Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-28 @ 7:30 AM
Study NCT ID:
NCT03164356
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2017-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'danieb25@uw.edu', 'phone': '206-221-5873', 'title': 'Daniel Ballesteros', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'through study completion, 4 years', 'description': 'Adverse Events were monitored/assessed, but none observed', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1 - Pre and Post Modification Observation, No Intervention', 'description': 'In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2 - Treatment Group, Pre and Post Modification', 'description': "Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3.", 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Arm 2 - Control Group, Pre and Post Modification', 'description': "Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist.", 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Arm 2 - Treatment Group Prosthetists, Pre and Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well.", 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Arm 2 - Control Group Prosthetists, Pre and Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well.", 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Significant Increases in Socket Comfort Score (SCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.'}, {'id': 'OG001', 'title': 'Arm 2 - Treatment', 'description': "Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3.\n\nBioimpedance monitor: Participant in aim 1 will be monitored using the bioimpedance monitor. Data obtained from the arm 1 cohort will be used to inform socket modifications made for arm 2 cohort."}, {'id': 'OG002', 'title': 'Arm 3 - Control', 'description': "Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist."}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.', 'description': "Participants are asked to quantify the overall comfort of their prosthesis by giving it a score between 0 and 10 with 0 as the least comfortable possible and 10 being the most comfortable possible. SCS scores were acquired both pre and post making modifications to the participant's prosthesis. For analysis purposes, the number of participants that had a significant positive change are counted for this outcome. Participants that had little to no change (a score difference \\<2) in SCS or had a negative change in SCS score were not counted.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Primary outcome measures from each group were collected pre and post modifications to their prosthesis. The experimental arm involved sharing bioimpedance data with the participants' prosthetist."}, {'type': 'SECONDARY', 'title': "Number of Participants With Net-Positive Increase in Prosthesis Satisfaction, Measured by the Patient's Overall Satisfaction With Their Entire Prosthesis", 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Pre and Post Modification Observation, No Intervention', 'description': 'In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.'}, {'id': 'OG001', 'title': 'Arm 2 - Treatment Group, Pre and Post Modification', 'description': "Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3."}, {'id': 'OG002', 'title': 'Arm 2 - Control Group, Pre and Post Modification', 'description': "Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist."}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.', 'description': 'Participants are asked to indicate their overall satisfaction with their prosthesis by drawing a line on a continuous scale running from extremely unhappy to extremely happy (0 to 100). For analysis purposes, the number of participants that had a net positive change are counted for this outcome. Participants that had a net negative or no change were not counted.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Primary outcome measures from each group were collected pre and post modifications to their prosthesis. The experimental arm involved sharing bioimpedance data with the participants' prosthetist."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Net-Positive Change in Ambulation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Pre and Post Modification Observation, No Intervention', 'description': 'In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.'}, {'id': 'OG001', 'title': 'Arm 2 - Treatment Group, Pre and Post Modification', 'description': "Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3."}, {'id': 'OG002', 'title': 'Arm 2 - Control Group, Pre and Post Modification', 'description': "Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist."}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.', 'description': 'Participants are asked to indicate their overall ability to walk with their prosthesis by drawing a line on a continuous scale running from "Cannot Walk at All" to "No Problem Walking" (0 to 100, respectively). They are also asked questions related to ambulation ability in unique circumstances, such as walking in close spaces, up and down stairs, up and down hills, on streets, on sidewalks, and on slippery surfaces. For analysis purposes, the number of participants that had a net positive change are counted for this outcome. Participants that had a net negative or no change were not counted.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Primary outcome measures from each group were collected pre and post modifications to their prosthesis. The experimental arm involved sharing bioimpedance data with the participants' prosthetist."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Net-Positive Change in Residual Limb Health Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Pre and Post Modification Observation, No Intervention', 'description': 'In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.'}, {'id': 'OG001', 'title': 'Arm 2 - Treatment Group, Pre and Post Modification', 'description': "Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3."}, {'id': 'OG002', 'title': 'Arm 2 - Control Group, Pre and Post Modification', 'description': "Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist."}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.', 'description': 'Participants are asked to indicate how much their residual limb sweats, smells, swells, develops rashes, develops ingrown hairs, and develops blisters, while wearing their prosthesis.They indicate this by drawing a line on a continuous scale running from "Extreme Amount" to "Not At All" (0 to 100, respectively). For analysis purposes, the number of participants that had a net positive change are counted for this outcome. Participants that had a net negative or no change were not counted.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Primary outcome measures from each group were collected pre and post modifications to their prosthesis. The experimental arm involved sharing bioimpedance data with the participants' prosthetist."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Net-Positive Change in Prosthesis Utility Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Pre and Post Modification Observation, No Intervention', 'description': 'In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.'}, {'id': 'OG001', 'title': 'Arm 2 - Treatment Group, Pre and Post Modification', 'description': "Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3."}, {'id': 'OG002', 'title': 'Arm 2 - Control Group, Pre and Post Modification', 'description': "Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist."}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.', 'description': 'Participants are asked to indicate various features related to the utility of their prosthesis by drawing a line on a continuous scale that ranges from "Terrible" to "Excellent" (0 to 100, respectively). Features include prosthesis fit, weight, comfort while standing, comfort while sitting, balance, effort, feel, and donning. For analysis purposes, the number of participants that had a net positive change are counted for this outcome. Participants that had a net negative or no change were not counted.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Primary outcome measures from each group were collected pre and post modifications to their prosthesis. The experimental arm involved sharing bioimpedance data with the participants' prosthetist."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Net-Positive Change in Prosthesis Well Being Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 - Pre and Post Modification Observation, No Intervention', 'description': 'In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.'}, {'id': 'OG001', 'title': 'Arm 2 - Treatment Group, Pre and Post Modification', 'description': "Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3."}, {'id': 'OG002', 'title': 'Arm 2 - Control Group, Pre and Post Modification', 'description': "Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist."}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.', 'description': 'Prosthesis users indicate their well being since their amputation and also rank their overall quality of life by marking a line on a scale ranging from "worst possible life" to "best possible life" (0 to 100, respectively). Participants who showed a positive net increase in this category were counted for each aim.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Primary outcome measures from each group were collected pre and post modifications to their prosthesis. The experimental arm involved sharing bioimpedance data with the participants' prosthetist."}, {'type': 'SECONDARY', 'title': 'Prosthetist Communication Assessment Score, Measured by the Communication Efficacy Between the Prosthetist and Their Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - Treatment Group Prosthetists, Pre Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}, {'id': 'OG001', 'title': 'Arm 2 - Control Group Prosthetists, Pre-Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '10'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, prior to socket modification', 'description': "Participants' prosthetists are asked to rate their ability to communicate the need for sock or behavioral changes to their patients participating in the study. They will indicate the score using a scale from 0 to 10 with 10 being the best possible communication and 0 being the worst possible communication.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Only participants that completed surveys both pre and post modifications to their patient's sockets were included in this analysis."}, {'type': 'SECONDARY', 'title': 'Types of Socket Modifications Implemented Per Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - Treatment Group, Pre and Post Modification', 'description': "Participants' socket modifications were based only on their prosthetists. Prosthetists for this group did not receive any bioimpedance data to inform their decisions."}, {'id': 'OG001', 'title': 'Arm 2 - Control Group, Pre and Post Modification', 'description': "Participants' socket modifications were based on their prosthetists after said prosthetists received bioimpedance data."}], 'classes': [{'title': 'New Socket', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Socket pad/insert', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'socket relief', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Suspension change', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, prior to socket modification', 'description': 'Participants\' prosthetists are asked the type of socket modification(s) that they implemented in free response format. Responses were simplified into 5 categories related to common modification changes. The most common themes were: fabrication of a new socket, addition of socket pads or an insert, creating socket reliefs, changing socket suspension, and other. Changes that fell under the "other" category were not necessarily related to changes in socket shape, such as changes in overall prosthesis alignment, prosthesis foot, fabrication materials, etc.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Only participants who completed the survey and whose patients completed pre and post-modification testing were included in this analysis. Prosthetists' responses from both the control and treatment groups are counted for this metric. Some prosthetists had more than one participant in the study which may impact total counts for this metric."}, {'type': 'SECONDARY', 'title': 'Effect of Socket Modification, Measured by the Impact of the Physical Modification Made to the Prosthesis to Socket Fit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - Treatment Group Prosthetists, Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}, {'id': 'OG001', 'title': 'Arm 2 - Control Group Prosthetists, Post-Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '10'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Participants\' prosthetists from both groups were asked to rate the effectiveness of the modification(s) that they implemented on a scale of 0 to 10 in which 10 is "Excellent" and 0 is "Terrible".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who completed the survey and whose patients completed pre and post modification treatment group testing were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Strategies Recommended to Minimize Limb Fluid Volume Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - Treatment Group Prosthetists, Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}, {'id': 'OG001', 'title': 'Arm 2 - Control Group Prosthetists, Post-Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}], 'classes': [{'title': 'New Sock Regimen', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Periodic Doffing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Activity Regimen', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Self-Care Regimen', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': "Participants' prosthetists are asked what changes to the participant's volume management strategy they recommended in free-response format. The following common themes were pulled from their responses: new sock regimen, periodic doffing, new activity regimen, new self-care regimen, other, and none. A count for how many prosthetists mentioned the same theme was tabulated.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who completed the survey and whose patients completed pre and post modification testing were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Effect of Volume Management Strategy, Measured by the Impact of the Changes in Volume Management to Socket Fit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - Treatment Group Prosthetists, Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}, {'id': 'OG001', 'title': 'Arm 2 - Control Group Prosthetists, Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Participants\' prosthetists are asked to rate the effectiveness of the strategies that they recommended on a scale of 0 to 10 in which 10 is "Excellent" and 0 is "Terrible".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who completed the survey and whose patients completed pre and post modification testing were included in this analysis. Note: two control group prosthetists did not provide an answer for this portion of the survey.'}, {'type': 'SECONDARY', 'title': 'Modification/Strategy Satisfaction, Measured by Overall Satisfaction of All Methods Employed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - Treatment Group Prosthetists, Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}, {'id': 'OG001', 'title': 'Arm 2 - Control Group Prosthetists, Post-Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '10'}, {'value': '7.9', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to rate their overall satisfaction with the socket modification and/or volume management change that was used for each participant by indicating a score from 0 to 10 with 10 being "Extremely Satisfied" and 0 being "Not Satisfied".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who completed the survey and whose patients completed pre and post modification testing were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Prosthetist Impression of Bioimpedance Results, Measured by General Feedback From Clinicians on the Bioimpedance Data They Are Given', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - Treatment Group Prosthetists, Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}], 'classes': [{'title': 'Found results helpful/interesting', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Results aligned with physiological expectations', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Results did not align with physiological expectations', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Highlighted detail of results', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to describe their impression of the bioimpedance results in a free response format. Common themes were gathered from responses and a count for each was tabulated based on gathered responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who completed the survey and whose patients completed pre and post modification testing in the "Treatment" group were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Prosthetist Use of Bioimpedance Results, Measured by General Feedback on How the Clinicians Use the Bioimpedance Data They Are Given', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - Treatment Group Prosthetists, Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}], 'classes': [{'title': 'To discuss daily activity patterns with patient', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'To communicate socket management topics with patient', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'To communicate physiological issues with patient', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'To inform socket modifications', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Unsure/Did Not Use', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to describe, in free response format how they used the bioimpedance results to inform their clinical practice. Common themes were gathered from responses and a count for each was tabulated based on gathered responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who completed the survey and whose patients completed pre and post modification testing in the "Treatment" group were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Bioimpedance Usefulness for Socket Design, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - Treatment Group Prosthetists, Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Participants\' prosthetists are asked to rate the effectiveness of the strategies that they recommended on a scale of 0 to 10 in which 10 is "Very Useful" and 0 is "Not Useful".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who completed the survey and whose patients completed pre and post modification testing in the "Treatment" group were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Bioimpedance for Volume Management, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - Treatment Group Prosthetists, Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to rate the utility of bioimpedance results in recommending volume management strategies to their patients. The rating scale is 0 to 10 with 10 being "Very Useful" and 0 being "Not Useful".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who completed the survey and whose patients completed pre and post-modification testing in the "Treatment" group were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Continuing Use of Bioimpedance Results, Measured by How Likely Clinicians Will be to Use Bioimpedance Data in the Future', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - Treatment Group Prosthetists, Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to indicate how likely they are to request bioimpedance data for their other patients by selecting a score from 0 to 10 with 10 with being "Very Likely" and 0 being "Not Likely at All".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who completed the survey and whose patients completed pre and post modification testing in the "Treatment" group were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Impact of Bioimpedance, Measured by How Bioimpedance Data Changed the Way Prosthetists Approach Problem Issues of Socket Fit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - Treatment Group Prosthetists, Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to quantify the impact that the bioimpedance had on the manner in which they approached the issue by rating the impact from 0 to 10 with 10 being "Very Impactful" and 0 being "No Impact".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who completed the survey and whose patients completed pre and post modification testing in the "Treatment" group were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - Treatment Group Prosthetists, Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}], 'classes': [{'title': 'magnitude of fluid volume change over the whole day', 'categories': [{'title': 'Identified as useful', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Did not identify as useful', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'fluid volume change by regions of the limb', 'categories': [{'title': 'Identified as useful', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Did not identify as useful', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'fluid volume change from different activities', 'categories': [{'title': 'Identified as useful', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Did not identify as useful', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'rate of fluid volume change over the whole day', 'categories': [{'title': 'Identified as useful', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Did not identify as useful', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'rate of fluid volume change over specific activity intervals', 'categories': [{'title': 'Identified as useful', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Did not identify as useful', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Other (pressure mapping based on limb volume)', 'categories': [{'title': 'Identified as useful', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Did not identify as useful', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to select from a list which bioimpedance data was most useful to them. The list items are: magnitude of fluid volume change over the whole day, fluid volume change by regions of the limb, fluid volume change from different activities, rate of fluid volume change over the whole day, and rate of fluid volume change over specific activity intervals', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who completed the survey and whose patients completed pre and post modification testing in the "Treatment" group were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Bioimpedance and Communication Measured by General Feedback on Whether Prosthetist-patient Communication is Improved Through Use of Bioimpedance Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - Treatment Group Prosthetists, Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to indicate the degree to which their use bioimpedance results improved the communication between them and their patients. They indicate this by selecting a value from 0 to 10 with 10 being "Highly Impactful" and 0 being "No Impact".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who completed the survey and whose patients completed pre and post modification testing in the "Treatment" group were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Outcome Enhancement, Measured by the Degree to Which Outcomes Are Improved Using Bioimpedance Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2 - Treatment Group Prosthetists, Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to indicated the degree to which clinical outcomes were enhanced by the use of bioimpedance results. They indicate this by selecting a value from 0 to 10 with 10 being "Positive Impact" and 0 being "Negative Impact".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants who completed the survey and whose patients completed pre and post modification testing in the "Treatment" group were included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1 - Pre and Post Modification Observation, No Intervention', 'description': 'In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.'}, {'id': 'FG001', 'title': 'Arm 2 - Treatment Group, Pre and Post Modification', 'description': "Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3."}, {'id': 'FG002', 'title': 'Arm 2 - Control Group, Pre and Post Modification', 'description': "Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist."}, {'id': 'FG003', 'title': 'Arm 2 - Prosthetists, Pre and Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Study timeframe interrupted by Coronavirus disease 2019 (COVID-19)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Subject Incarcerated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Prosthetist unable to participate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '68', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1 - Pre and Post Modification Observation, No Intervention', 'description': 'In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.'}, {'id': 'BG001', 'title': 'Arm 2 - Treatment Group, Pre and Post Modification', 'description': "Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3."}, {'id': 'BG002', 'title': 'Arm 2 - Control Group, Pre and Post Modification', 'description': "Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist."}, {'id': 'BG003', 'title': 'Arm 2 - Treatment Group Prosthetists, Pre and Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}, {'id': 'BG004', 'title': 'Arm 2 - Control Group Prosthetists, Pre and Post Modifications', 'description': "Participant's in Arm 2 had their prosthetists recruited as well. Prosthetists for participants in both control and treatment groups were surveyed regarding modifications to their patient's socket. Prosthetists for participants in Arm 2 were also given pre-modification bioImpedance data as a supplement to their socket modification process and were surveyed regarding this data as well."}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '68', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-27', 'size': 288788, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-28T18:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-28', 'studyFirstSubmitDate': '2017-03-16', 'resultsFirstSubmitDate': '2022-01-14', 'studyFirstSubmitQcDate': '2017-05-19', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-25', 'studyFirstPostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Significant Increases in Socket Comfort Score (SCS)', 'timeFrame': 'Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.', 'description': "Participants are asked to quantify the overall comfort of their prosthesis by giving it a score between 0 and 10 with 0 as the least comfortable possible and 10 being the most comfortable possible. SCS scores were acquired both pre and post making modifications to the participant's prosthesis. For analysis purposes, the number of participants that had a significant positive change are counted for this outcome. Participants that had little to no change (a score difference \\<2) in SCS or had a negative change in SCS score were not counted."}], 'secondaryOutcomes': [{'measure': "Number of Participants With Net-Positive Increase in Prosthesis Satisfaction, Measured by the Patient's Overall Satisfaction With Their Entire Prosthesis", 'timeFrame': 'Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.', 'description': 'Participants are asked to indicate their overall satisfaction with their prosthesis by drawing a line on a continuous scale running from extremely unhappy to extremely happy (0 to 100). For analysis purposes, the number of participants that had a net positive change are counted for this outcome. Participants that had a net negative or no change were not counted.'}, {'measure': 'Number of Participants With Net-Positive Change in Ambulation Score', 'timeFrame': 'Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.', 'description': 'Participants are asked to indicate their overall ability to walk with their prosthesis by drawing a line on a continuous scale running from "Cannot Walk at All" to "No Problem Walking" (0 to 100, respectively). They are also asked questions related to ambulation ability in unique circumstances, such as walking in close spaces, up and down stairs, up and down hills, on streets, on sidewalks, and on slippery surfaces. For analysis purposes, the number of participants that had a net positive change are counted for this outcome. Participants that had a net negative or no change were not counted.'}, {'measure': 'Number of Participants With Net-Positive Change in Residual Limb Health Score', 'timeFrame': 'Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.', 'description': 'Participants are asked to indicate how much their residual limb sweats, smells, swells, develops rashes, develops ingrown hairs, and develops blisters, while wearing their prosthesis.They indicate this by drawing a line on a continuous scale running from "Extreme Amount" to "Not At All" (0 to 100, respectively). For analysis purposes, the number of participants that had a net positive change are counted for this outcome. Participants that had a net negative or no change were not counted.'}, {'measure': 'Number of Participants With Net-Positive Change in Prosthesis Utility Score', 'timeFrame': 'Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.', 'description': 'Participants are asked to indicate various features related to the utility of their prosthesis by drawing a line on a continuous scale that ranges from "Terrible" to "Excellent" (0 to 100, respectively). Features include prosthesis fit, weight, comfort while standing, comfort while sitting, balance, effort, feel, and donning. For analysis purposes, the number of participants that had a net positive change are counted for this outcome. Participants that had a net negative or no change were not counted.'}, {'measure': 'Number of Participants With Net-Positive Change in Prosthesis Well Being Score', 'timeFrame': 'Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.', 'description': 'Prosthesis users indicate their well being since their amputation and also rank their overall quality of life by marking a line on a scale ranging from "worst possible life" to "best possible life" (0 to 100, respectively). Participants who showed a positive net increase in this category were counted for each aim.'}, {'measure': 'Prosthetist Communication Assessment Score, Measured by the Communication Efficacy Between the Prosthetist and Their Patient', 'timeFrame': 'Baseline, prior to socket modification', 'description': "Participants' prosthetists are asked to rate their ability to communicate the need for sock or behavioral changes to their patients participating in the study. They will indicate the score using a scale from 0 to 10 with 10 being the best possible communication and 0 being the worst possible communication."}, {'measure': 'Types of Socket Modifications Implemented Per Group', 'timeFrame': 'Baseline, prior to socket modification', 'description': 'Participants\' prosthetists are asked the type of socket modification(s) that they implemented in free response format. Responses were simplified into 5 categories related to common modification changes. The most common themes were: fabrication of a new socket, addition of socket pads or an insert, creating socket reliefs, changing socket suspension, and other. Changes that fell under the "other" category were not necessarily related to changes in socket shape, such as changes in overall prosthesis alignment, prosthesis foot, fabrication materials, etc.'}, {'measure': 'Effect of Socket Modification, Measured by the Impact of the Physical Modification Made to the Prosthesis to Socket Fit', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Participants\' prosthetists from both groups were asked to rate the effectiveness of the modification(s) that they implemented on a scale of 0 to 10 in which 10 is "Excellent" and 0 is "Terrible".'}, {'measure': 'Strategies Recommended to Minimize Limb Fluid Volume Loss', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': "Participants' prosthetists are asked what changes to the participant's volume management strategy they recommended in free-response format. The following common themes were pulled from their responses: new sock regimen, periodic doffing, new activity regimen, new self-care regimen, other, and none. A count for how many prosthetists mentioned the same theme was tabulated."}, {'measure': 'Effect of Volume Management Strategy, Measured by the Impact of the Changes in Volume Management to Socket Fit', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Participants\' prosthetists are asked to rate the effectiveness of the strategies that they recommended on a scale of 0 to 10 in which 10 is "Excellent" and 0 is "Terrible".'}, {'measure': 'Modification/Strategy Satisfaction, Measured by Overall Satisfaction of All Methods Employed', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to rate their overall satisfaction with the socket modification and/or volume management change that was used for each participant by indicating a score from 0 to 10 with 10 being "Extremely Satisfied" and 0 being "Not Satisfied".'}, {'measure': 'Prosthetist Impression of Bioimpedance Results, Measured by General Feedback From Clinicians on the Bioimpedance Data They Are Given', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to describe their impression of the bioimpedance results in a free response format. Common themes were gathered from responses and a count for each was tabulated based on gathered responses.'}, {'measure': 'Prosthetist Use of Bioimpedance Results, Measured by General Feedback on How the Clinicians Use the Bioimpedance Data They Are Given', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to describe, in free response format how they used the bioimpedance results to inform their clinical practice. Common themes were gathered from responses and a count for each was tabulated based on gathered responses.'}, {'measure': 'Bioimpedance Usefulness for Socket Design, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Participants\' prosthetists are asked to rate the effectiveness of the strategies that they recommended on a scale of 0 to 10 in which 10 is "Very Useful" and 0 is "Not Useful".'}, {'measure': 'Bioimpedance for Volume Management, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to rate the utility of bioimpedance results in recommending volume management strategies to their patients. The rating scale is 0 to 10 with 10 being "Very Useful" and 0 being "Not Useful".'}, {'measure': 'Continuing Use of Bioimpedance Results, Measured by How Likely Clinicians Will be to Use Bioimpedance Data in the Future', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to indicate how likely they are to request bioimpedance data for their other patients by selecting a score from 0 to 10 with 10 with being "Very Likely" and 0 being "Not Likely at All".'}, {'measure': 'Impact of Bioimpedance, Measured by How Bioimpedance Data Changed the Way Prosthetists Approach Problem Issues of Socket Fit', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to quantify the impact that the bioimpedance had on the manner in which they approached the issue by rating the impact from 0 to 10 with 10 being "Very Impactful" and 0 being "No Impact".'}, {'measure': 'Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to select from a list which bioimpedance data was most useful to them. The list items are: magnitude of fluid volume change over the whole day, fluid volume change by regions of the limb, fluid volume change from different activities, rate of fluid volume change over the whole day, and rate of fluid volume change over specific activity intervals'}, {'measure': 'Bioimpedance and Communication Measured by General Feedback on Whether Prosthetist-patient Communication is Improved Through Use of Bioimpedance Data', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to indicate the degree to which their use bioimpedance results improved the communication between them and their patients. They indicate this by selecting a value from 0 to 10 with 10 being "Highly Impactful" and 0 being "No Impact".'}, {'measure': 'Outcome Enhancement, Measured by the Degree to Which Outcomes Are Improved Using Bioimpedance Data', 'timeFrame': 'Post modification, minimum 4 weeks after patient started study', 'description': 'Prosthetists are asked to indicated the degree to which clinical outcomes were enhanced by the use of bioimpedance results. They indicate this by selecting a value from 0 to 10 with 10 being "Positive Impact" and 0 being "Negative Impact".'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Limb Fluid Volume Management', 'Prosthetic Socket Modification'], 'conditions': ['Transtibial Amputee']}, 'referencesModule': {'references': [{'pmid': '22773260', 'type': 'BACKGROUND', 'citation': 'Sanders JE, Severance MR, Allyn KJ. Computer-socket manufacturing error: how much before it is clinically apparent? J Rehabil Res Dev. 2012;49(4):567-82. doi: 10.1682/jrrd.2011.05.0097.'}, {'pmid': '10659798', 'type': 'BACKGROUND', 'citation': 'Legro MW, Reiber G, del Aguila M, Ajax MJ, Boone DA, Larsen JA, Smith DG, Sangeorzan B. Issues of importance reported by persons with lower limb amputations and prostheses. J Rehabil Res Dev. 1999 Jul;36(3):155-63.'}, {'pmid': '15827911', 'type': 'BACKGROUND', 'citation': 'Kavounoudias A, Tremblay C, Gravel D, Iancu A, Forget R. Bilateral changes in somatosensory sensibility after unilateral below-knee amputation. Arch Phys Med Rehabil. 2005 Apr;86(4):633-40. doi: 10.1016/j.apmr.2004.10.030.'}, {'pmid': '24933719', 'type': 'BACKGROUND', 'citation': 'Sanders JE, Cagle JC, Allyn KJ, Harrison DS, Ciol MA. How do walking, standing, and resting influence transtibial amputee residual limb fluid volume? J Rehabil Res Dev. 2014;51(2):201-12. doi: 10.1682/JRRD.2013.04.0085.'}, {'pmid': '22773526', 'type': 'BACKGROUND', 'citation': 'Sanders JE, Harrison DS, Allyn KJ, Myers TR, Ciol MA, Tsai EC. How do sock ply changes affect residual-limb fluid volume in people with transtibial amputation? J Rehabil Res Dev. 2012;49(2):241-56. doi: 10.1682/jrrd.2011.02.0022.'}, {'pmid': '22068373', 'type': 'BACKGROUND', 'citation': 'Sanders JE, Fatone S. Residual limb volume change: systematic review of measurement and management. J Rehabil Res Dev. 2011;48(8):949-86. doi: 10.1682/jrrd.2010.09.0189.'}, {'pmid': '8110166', 'type': 'BACKGROUND', 'citation': 'Van Loan MD, Withers P, Matthie J, Mayclin PL. Use of bioimpedance spectroscopy to determine extracellular fluid, intracellular fluid, total body water, and fat-free mass. Basic Life Sci. 1993;60:67-70. doi: 10.1007/978-1-4899-1268-8_13. 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Epub 2011 May 6.'}, {'pmid': '21095144', 'type': 'BACKGROUND', 'citation': 'Potier L, Abi Khalil C, Mohammedi K, Roussel R. Use and utility of ankle brachial index in patients with diabetes. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):110-6. doi: 10.1016/j.ejvs.2010.09.020. Epub 2010 Nov 20.'}, {'pmid': '9866429', 'type': 'BACKGROUND', 'citation': 'Owings MF, Kozak LJ. Ambulatory and inpatient procedures in the United States, 1996. Vital Health Stat 13. 1998 Nov;(139):1-119.'}, {'pmid': '15129395', 'type': 'BACKGROUND', 'citation': 'Pezzin LE, Dillingham TR, Mackenzie EJ, Ephraim P, Rossbach P. Use and satisfaction with prosthetic limb devices and related services. Arch Phys Med Rehabil. 2004 May;85(5):723-9. doi: 10.1016/j.apmr.2003.06.002.'}, {'pmid': '18295618', 'type': 'BACKGROUND', 'citation': 'Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.'}, {'pmid': '20803404', 'type': 'BACKGROUND', 'citation': 'Berke GM, Fergason J, Milani JR, Hattingh J, McDowell M, Nguyen V, Reiber GE. Comparison of satisfaction with current prosthetic care in veterans and servicemembers from Vietnam and OIF/OEF conflicts with major traumatic limb loss. J Rehabil Res Dev. 2010;47(4):361-71. doi: 10.1682/jrrd.2009.12.0193.'}], 'seeAlsoLinks': [{'url': 'https://www.sandia.gov/research/dynamic-socket/', 'label': 'Sandia National Laboratories, Dynamic socket'}]}, 'descriptionModule': {'briefSummary': "The purpose of the proposed study is to conduct research on individuals with lower limb amputation, evaluating if residual limb fluid volume data collected using a novel non-invasive device is beneficial towards prosthetic prescription, fit, and comfort as determined by amputee test subjects and practitioners (prosthetists). Participants' residual limb fluid volume will be monitored through bioimpedance analysis both before and after a practitioner-issued modification to the prosthesis as an observational cohort study and then as a blinded randomized control trial in which the data may or may not be shared with the practitioner before the modification is made to the prosthesis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Transtibial amputees, unilateral or bilateral\n* Amputation at least 18 months prior\n* Walking activity of at least 7 hours per week\n* Medicare functional classification level of 2 or higher\n* Residual limb length of at least 9 centimeters\n* Detrimental impacts to socket fit caused by residual limb volume fluctuations\n* Indication for augmented suspension, socket modification/change, sock application removal or activity modification\n\nExclusion Criteria:\n\n* Incidence of skin breakdown\n* Inability to ambulate continuously on a level walkway'}, 'identificationModule': {'nctId': 'NCT03164356', 'briefTitle': 'Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Portable Bioimpedance Monitoring: Testing a New Diagnostic Interface', 'orgStudyIdInfo': {'id': 'STUDY00000969'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Arm 1', 'description': 'In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.'}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 - Experimental', 'description': "Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3.", 'interventionNames': ['Device: Bioimpedance monitor']}, {'type': 'NO_INTERVENTION', 'label': 'Arm 3 - Control', 'description': "Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist."}], 'interventions': [{'name': 'Bioimpedance monitor', 'type': 'DEVICE', 'description': 'Participant in aim 1 will be monitored using the bioimpedance monitor. Data obtained from the arm 1 cohort will be used to inform socket modifications made for arm 2 cohort.', 'armGroupLabels': ['Arm 2 - Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Bioengineering', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Joan E Sanders, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Bioengineering', 'investigatorFullName': 'Joan Sanders', 'investigatorAffiliation': 'University of Washington'}}}}