Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-29 @ 8:47 PM
Study NCT ID:
NCT03965403
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2019-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Upper Extremity Rehabilitation With the BURT Robotic Arm
Sponsor:
Organization:
Raw JSON
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Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.\n\nArm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.43', 'spread': '11.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Assessment of upper-extremity function by the performance time of the Wolf Motor Function Test). The average of the 15 items is reported. The time ranges from 0 to 120 seconds. A decrease in performance time is associated with improved upper-extremity function.', 'unitOfMeasure': 'Time (seconds)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline in Motor Activity Log Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm Motor Function Retraining With BURT', 'description': 'All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. 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Higher scores are associated with better movement quality.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm Motor Function Retraining With BURT', 'description': 'All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.\n\nArm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Subject not meeting eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm Motor Function Retraining With BURT', 'description': 'All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. 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The average of the 15 items is reported. The time ranges from 0 to 120 seconds. A decrease in performance time is associated with improved upper-extremity function.'}, {'measure': 'Changes From Baseline in Motor Activity Log Scores', 'timeFrame': '6 weeks', 'description': 'Use of upper extremity in daily life. The self-reported amount of use is reported on a scale from 0 to 5. A score of zero is assigned when the hemiparetic side is not used during the activity of daily living, a score of 5 is assigned when the hemiparetic side is used as much as before the stroke. The 30 items of the scale are averaged. Higher scores are a sign of better use in daily life.'}, {'measure': 'Changes From Baseline in Modified Ashworth Scale Scores', 'timeFrame': '6 weeks', 'description': 'Assessment of muscle tone for upper extremity muscles. Score rank from 0 (no tone) to 4 (no movement possible). Lower scores indicates a better outcome.\n\nTone at the shoulder and elbow were measured'}, {'measure': 'Changes From Baseline in Articulations Range of Motion', 'timeFrame': '6 weeks', 'description': 'Assessment of active arm range of motion with goniometry. Results are reported in degrees and higher ranges include better outcomes.'}, {'measure': 'Changes From Baseline in Manual Muscle Testing Scale Scores', 'timeFrame': '6 weeks', 'description': 'Assessment of arm muscle strength using the manual muscle testing scale ranking from 0 (no contraction) to 10 (maximal strength). Higher scores indicate better outcomes.'}, {'measure': 'Changes From Baseline in Wolf Motor Function Test Scores (FAS Subcale)', 'timeFrame': '6 weeks', 'description': 'Assessment of upper-extremity function with the Functional ability subscale of the Wolf Motor Function Test.\n\nThe average of the 15 items is reported. Scores ranges from 0 to 5, they rate the quality of the movement performance. 0= do not attempt, up to 5= identical to contralateral side. Higher scores are associated with better movement quality.'}], 'primaryOutcomes': [{'measure': 'Changes From Baseline in Fugl-Meyer Upper Extremity Scores', 'timeFrame': '6 weeks', 'description': 'Assessment of upper extremity impairments. Individual items of the scale are summed for a total score ranking from 0 to 66. Higher scores indicate better outcomes.'}], 'secondaryOutcomes': [{'measure': 'Changes From Baseline in Goal Attainment Scale Scores', 'timeFrame': '6 weeks', 'description': "Standardized measure of goals selection and scaling to calculate the extend to which the participant's goals are met.\n\nThe Goal Attainment Scale ranges from -2 to +2. Positive scores indicates goals are better than expected, score of 0 indicates goals are met and negative scores indicates goals aren't met."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['stroke', 'hemiparesis', 'Robotic'], 'conditions': ['Stroke', 'Hemiparesis']}, 'descriptionModule': {'briefSummary': "The overall objective of the proposed study is to carry out usability and design-evaluation assessments of the BURT robotic device for delivering long-term intervention in stroke survivors. The BURT is an upper extremity robotic device that enables the user to see and feel engaging games that encourage intensive therapy. The investigators intend to recruit up to 10 stroke survivors over the course of the study. Participants will train their arm with the BURT for 18 sessions over approximately 6 weeks then participate in a question/answer formatted discussion with research staff to discuss the usability of the device. The investigators will also assess participant's arm function at baseline and after the training sessions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female, age 18-80;\n* Having had a stroke (ischemic or hemorrhagic) at least 6 months prior to study\n* Moderate to severe upper-limb motor impairments (score of 15-45 out of 66 on the Fugl- Meyer Scale);\n* Community dwelling;\n* Able to physically fit in the device.\n\nExclusion Criteria:\n\n* Current participation in rehabilitation program targeting upper extremity function;\n* Cognitive impairment resulting to inability to follow instructions or inability to sustain attention for more than 10 minutes;\n* Visual impairments not corrected with lenses (visual loss);\n* Aphasia sufficient to limit comprehension and completion of the treatment protocol;\n* No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy;\n* Increased muscle tone (passive movement is difficult);\n* Previous diagnosis of neurological diseases other than stroke;\n* Other conditions affecting function of the stroke affected upper limb;\n* Individuals who present with the following: open wounds, fragile skin, active infection'}, 'identificationModule': {'nctId': 'NCT03965403', 'briefTitle': 'Upper Extremity Rehabilitation With the BURT Robotic Arm', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': 'Upper Extremity Rehabilitation With the BURT Robotic Arm: a Feasibility Study', 'orgStudyIdInfo': {'id': '2016P002590'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm motor function retraining with BURT', 'description': 'All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.', 'interventionNames': ['Device: Arm motor function retraining with BURT']}], 'interventions': [{'name': 'Arm motor function retraining with BURT', 'type': 'DEVICE', 'description': 'Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions', 'armGroupLabels': ['Arm motor function retraining with BURT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Spaulding Rehabilitation Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Director of the Motion Analysis Laboratory', 'investigatorFullName': 'Paolo Bonato', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}