Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-04 @ 8:40 AM
Study NCT ID:
NCT06468059
Status:
COMPLETED
Last Update Posted:
2025-09-17
First Post:
2024-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mgeil@kennesaw.edu', 'phone': '(470) 578-4805', 'title': 'Mark Geil', 'organization': 'Kennesaw State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'For each intervention, the period of time for adverse event monitoring was the 3 to 4 hour period during which the device was worn for the in-lab gait sessions. The participants did not wear the experimental intervention for home or daily use in this study.', 'description': 'The risks associated with study participation are no greater than minimal risk as defined in 45 CFR 46.102(i): "Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."', 'eventGroups': [{'id': 'EG000', 'title': 'Prescribed Ankle', 'description': 'Prescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Layered Low Profile Foot (LPF)', 'description': 'Layered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Energy Stored (TES)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prescribed Ankle', 'description': 'Prescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.'}, {'id': 'OG001', 'title': 'Layered Low Profile Foot (LPF)', 'description': 'Layered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 1 day', 'description': 'TES is the amount of energy absorbed by the ankle joint during early and middle stance. It is the integral of the product of joint torque and angular velocity, as determined through inverse dynamics.', 'unitOfMeasure': 'Joules', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ankle Quasi-Stiffness (AQS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prescribed Ankle', 'description': 'Prescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.'}, {'id': 'OG001', 'title': 'Layered Low Profile Foot (LPF)', 'description': 'Layered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 1 day', 'description': 'AQS is a measure of joint deformation under an applied load. It is extracted from the torque-angle relationship during walking determined through inverse dynamics. The ideal AQS varies from person to person, but in this study we were interested in seeing if the prostheses could achiever lower AQS.', 'unitOfMeasure': 'Newton meters per degree', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Walking Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prescribed Ankle', 'description': 'Prescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.'}, {'id': 'OG001', 'title': 'Layered Low Profile Foot (LPF)', 'description': 'Layered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.27', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 1 day', 'description': 'This is the linear rate of change of position when a person walks, typically given in m/s.', 'unitOfMeasure': 'Meters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Likert Scale Rating of Device Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prescribed Ankle', 'description': 'Prescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.'}, {'id': 'OG001', 'title': 'Layered Low Profile Foot (LPF)', 'description': 'Layered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 1 day', 'description': "A 1 to 10 rating of device satisfaction where the pre-trial perceived device satisfaction of the participant's prescribed ankle is defined as a 5 out of 10. 1 is defined as completely unacceptable, and 10 is defined as ideal performance.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Layered Low Profile Foot (LPF) vs. Prescribed Ankle', 'description': 'In this arm, subjects will first test the LPF and then complete the tests with their prescribed ankle.\n\nLayered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior while simultaneously exhibiting high mechanical strength.\n\nPrescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.'}, {'id': 'FG001', 'title': 'Prescribed Ankle vs. Layered Low Profile Foot (LPF)', 'description': 'In this arm, subjects will first complete the tests with their prescribed ankle and then test the LPF.\n\nLayered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior while simultaneously exhibiting high mechanical strength.\n\nPrescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '6 subjects were enrolled between 3/21/2024 and 7/16/2024 at Kennesaw State University.', 'preAssignmentDetails': '6 of 6 patients completed this crossover study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Layered Low Profile Foot (LPF) vs. Prescribed Ankle', 'description': 'In this arm, subjects will first test the LPF and then complete the tests with their prescribed ankle.\n\nLayered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior while simultaneously exhibiting high mechanical strength.\n\nPrescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.'}, {'id': 'BG001', 'title': 'Prescribed Ankle vs. Layered Low Profile Foot (LPF)', 'description': 'In this arm, subjects will first complete the tests with their prescribed ankle and then test the LPF.\n\nLayered Low Profile Foot: The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior while simultaneously exhibiting high mechanical strength.\n\nPrescribed Ankle: The prescribed ankle is the prosthetic ankle that the subject wears for daily use.'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-08-13', 'size': 334455, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-08-13T14:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The control prosthesis and the experimental prosthesis are covered by a sock to prevent the participant from knowing which has been fit.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2024-06-07', 'resultsFirstSubmitDate': '2025-08-13', 'studyFirstSubmitQcDate': '2024-06-12', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-02', 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Energy Stored (TES)', 'timeFrame': 'through study completion, an average of 1 day', 'description': 'TES is the amount of energy absorbed by the ankle joint during early and middle stance. It is the integral of the product of joint torque and angular velocity, as determined through inverse dynamics.'}], 'secondaryOutcomes': [{'measure': 'Ankle Quasi-Stiffness (AQS)', 'timeFrame': 'through study completion, an average of 1 day', 'description': 'AQS is a measure of joint deformation under an applied load. It is extracted from the torque-angle relationship during walking determined through inverse dynamics. The ideal AQS varies from person to person, but in this study we were interested in seeing if the prostheses could achiever lower AQS.'}, {'measure': 'Walking Speed', 'timeFrame': 'through study completion, an average of 1 day', 'description': 'This is the linear rate of change of position when a person walks, typically given in m/s.'}, {'measure': 'Likert Scale Rating of Device Satisfaction', 'timeFrame': 'through study completion, an average of 1 day', 'description': "A 1 to 10 rating of device satisfaction where the pre-trial perceived device satisfaction of the participant's prescribed ankle is defined as a 5 out of 10. 1 is defined as completely unacceptable, and 10 is defined as ideal performance."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Amputation']}, 'descriptionModule': {'briefSummary': 'The investigators have developed a novel layered low-profile prosthetic foot that is able to provide enhanced compliance without sacrificing strength for individuals with transtibial amputation who have long residual limbs. It is hypothesized that the proposed prosthesis will offer similar benefits to these individuals as comparable higher profile prostheses offer users with shorter residual limbs. The primary goal of this Phase I proposal is to assess the degree to which the proposed prosthesis can provide benefits to prosthesis users in this population, along with characterizing the degree to which the novel prosthesis emulates its taller counterparts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-89 years old\n2. unilateral transtibial amputation\n3. daily use of a low profile foot\n4. cognitive ability to understand and willingness to provide informed consent and follow the study protocol\n\nExclusion Criteria:\n\n1. unable to perform walking for 2 minutes without an assistive device\n2. other health conditions which may prevent them from participating in the study'}, 'identificationModule': {'nctId': 'NCT06468059', 'briefTitle': 'Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot', 'organization': {'class': 'INDUSTRY', 'fullName': 'Little Room Innovations, LLC'}, 'officialTitle': 'Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot', 'orgStudyIdInfo': {'id': 'R43HD110316', 'link': 'https://reporter.nih.gov/quickSearch/R43HD110316', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Layered Low Profile Foot (LPF) vs. Prescribed Ankle', 'description': 'In this arm, subjects will first test the LPF and then complete the tests with their prescribed ankle.', 'interventionNames': ['Device: Layered Low Profile Foot', 'Device: Prescribed Ankle']}, {'type': 'EXPERIMENTAL', 'label': 'Prescribed Ankle vs. Layered Low Profile Foot (LPF)', 'description': 'In this arm, subjects will first complete the tests with their prescribed ankle and then test the LPF.', 'interventionNames': ['Device: Layered Low Profile Foot', 'Device: Prescribed Ankle']}], 'interventions': [{'name': 'Layered Low Profile Foot', 'type': 'DEVICE', 'otherNames': ['LPF'], 'description': 'The layered LPF is a novel low-profile prosthetic foot that provides compliant behavior while simultaneously exhibiting high mechanical strength.', 'armGroupLabels': ['Layered Low Profile Foot (LPF) vs. Prescribed Ankle', 'Prescribed Ankle vs. Layered Low Profile Foot (LPF)']}, {'name': 'Prescribed Ankle', 'type': 'DEVICE', 'otherNames': ['Daily Use Prosthesis'], 'description': 'The prescribed ankle is the prosthetic ankle that the subject wears for daily use.', 'armGroupLabels': ['Layered Low Profile Foot (LPF) vs. Prescribed Ankle', 'Prescribed Ankle vs. Layered Low Profile Foot (LPF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30144', 'city': 'Kennesaw', 'state': 'Georgia', 'country': 'United States', 'facility': 'Kennesaw State University', 'geoPoint': {'lat': 34.02343, 'lon': -84.61549}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Little Room Innovations, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kennesaw State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}