Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-01-03 @ 10:13 PM
Study NCT ID:
NCT05626894
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2022-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2022-11-06', 'studyFirstSubmitQcDate': '2022-11-15', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Canadian Occupational Performance Measure (COPM)', 'timeFrame': 'Change from baseline Canadian Occupational Performance Measure (COPM) score at 6 months', 'description': 'Semi-structured interview to assess outcomes in the areas of self-care, productivity and leisure. Score from 0 (worst) to 10 (best).'}, {'measure': 'Number of times the activity goals are reached', 'timeFrame': 'At 6 months', 'description': 'Number of times the activity goals set are reached over the study duration'}], 'primaryOutcomes': [{'measure': 'Change in Motor Activity Log-Amount of Use', 'timeFrame': 'Change from baseline Motor Activity Log-Amount of Use score at 6 months', 'description': 'Self-reported measure of upper-extremity performance. Score from 0 (worst) to 5 (best)'}, {'measure': 'Change in Fugl-Meyer Upper-Extremity', 'timeFrame': 'Change from baseline Fugl-Meyer Upper-Extremity score at 6 months', 'description': 'Observed measure of upper-extremity motor impairment following a stroke. Score from 0 (worst) to 66 (best)'}, {'measure': 'Change in Upper-Extremity Activity Counts', 'timeFrame': 'Change from baseline Upper-Extremity Activity Counts score at 6 months', 'description': 'Activity of the hemiparetic upper-extremity in the home setting as measured with wrist-worn accelerometers'}], 'secondaryOutcomes': [{'measure': 'Change in Motor Activity Log-Quality of Use', 'timeFrame': 'Change from baseline Motor Activity Log-Quality of Use score at 6 months', 'description': 'Self-reported measure of upper-extremity quality of use. Score from 0 (worst) to 5 (best)'}, {'measure': 'Change in Wolf-Motor Function Test - Time subscale', 'timeFrame': 'Change from baseline Wolf-Motor Function Test - Time subscale score at 6 months', 'description': 'Observed (timed) measure of upper-extremity function. Time from 0 to 120 seconds (maximum time allowed to attempt to perform a motor task)'}, {'measure': 'Change in Wolf-Motor Function Test - Functional ability subscale', 'timeFrame': 'Change from baseline Wolf-Motor Function Test - Functional ability subscale score at 6 months', 'description': 'Measure of upper-extremity quality of movement based on visual observation. Score from 0 (worst) to 5 (best)'}, {'measure': 'Change in Stroke Impact Scale (SIS)', 'timeFrame': 'Change from baseline Stroke Impact Scale (SIS) score at 6 months', 'description': 'Self-reported measure of quality of life after a stroke. Score from 0 (best) to 42 (worst)'}, {'measure': 'Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale', 'timeFrame': 'Change from baseline Stroke Self-Efficacy Questionnaire (SSEQ) - Activity subscale score at 6 months', 'description': 'Self-reported measure of upper-extremity efficacy in activities of daily living. Score from 0 (worst) to 10 (best).'}, {'measure': 'Change in Stroke Self-Efficacy Questionnaire (SSEQ) - Self-management subscale', 'timeFrame': 'Change from baseline Self-Efficacy Questionnaire (SSEQ) - Self-management subscale score at 6 months', 'description': 'Self-reported measure of upper-extremity efficacy in activities of daily living. Score from 0 (worst) to 10 (best).'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['StrokeWear', 'BioSensics', 'Behavioral intervention'], 'conditions': ['Stroke', 'Stroke Sequelae', 'Hemiparesis;Poststroke/CVA']}, 'descriptionModule': {'briefSummary': 'The proposed study is a two-arm randomized clinical trial designed to assess the effects of the StrokeWear system on clinical outcomes over a period of 6-months in chronic stroke survivors. The Intervention group will use StrokeWear system in combination to a motor and behavioral home intervention whereas the Control group will follow usual care which consists of a home-exercise plan (HEP).', 'detailedDescription': 'The proposed study is a two-arm randomized clinical trial designed to assess the effects of the StrokeWear system on clinical outcomes over a period of 6-months in chronic stroke survivors. The Intervention group will use StrokeWear system in combination to a motor and behavioral home intervention whereas the Control group will follow usual care which consists of a home-exercise plan (HEP).\n\nStudy participants will be asked to take part in 4 evaluation study visits: one screening and enrollment visit, and three evaluation visits (at baseline, at 3 months and at 6 months - at the intervention completion). Subject upper-extremity motor function will be assessed across domains of the International Classification of Functioning, Disability and Health (ICF) model. Groups will be stratified by baseline motor impairment and stroke chronicity.\n\nSubjects randomized to the intervention group will take part of weekly coaching sessions during the first month, bi-weekly sessions during the months 2 and 3, and monthly sessions during months 4-6. These sessions will be held in-person or remotely, based on the study participant preference.\n\nSubjects randomized to the control group will take part of monthly visits, held in-person or remotely (based on study participant preference), to re-evaluate the home-exercise plan and prescribe an update list of exercises for the following month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, 18-85 years of age at the time of enrollment;\n* Anterior circulation ischemic stroke at least 6 months and up to 5 years prior to study enrollment;\n* Unilateral upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 20 and 45;\n* Intact cognitive function to understand the study procedures and goal setting (MMSE score above 23 and able to follow 3 step command);\n* Being familiar and comfortable with the use of a tablet or smartphone.\n\nExclusion Criteria:\n\n* Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe performance of UE tasks;\n* Visual impairments as assessed by the NIH Stroke Scale Visual Field subscale (only subjects with no visual loss will participate in the study); or hemispatial neglect that would impair the subject ability to see feedback on the app screen (as assessed with the star cancellation test);\n* Individuals with open wounds or recent fracture (less than 3 months) in the UE, fragile skin or active infection as evaluated by the study therapist;\n* Individuals currently enrolled in a UE rehabilitation program (i.e., OT, research study)\n* Upper-extremity orthopedic injuries or severe pain resulting in movement limitations;\n* Diagnosis of other neurological disease (i.e., Parkinson's disease, multiple sclerosis, ...);\n* Severe proprioceptive deficits that impair the ability to process the vibration feedback, as assessed by physical examination during screening as assessed by the study therapist;\n* Not understanding spoken or written English;\n* Recent (less than 3 months) Botox injection in the UE or plan to undergo injections during the study timeline;\n* Contralateral motor deficits as assessed by clinical examination;\n* Brainstem and cerebellar stroke."}, 'identificationModule': {'nctId': 'NCT05626894', 'briefTitle': 'Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': 'A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Home Daily Life of Chronic Stroke Survivors', 'orgStudyIdInfo': {'id': '2022P002943'}, 'secondaryIdInfos': [{'id': 'R44HD084035', 'link': 'https://reporter.nih.gov/quickSearch/R44HD084035', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'StrokeWear Motor and Behavioral Intervention', 'description': 'Stroke survivors randomized to this group will receive standard occupational and physical therapy in addition to a behavioral intervention aimed to encourage stroke survivors to use their affect arm during the performance of activities of daily living.', 'interventionNames': ['Combination Product: StrokeWear Motor and Behavioral Intervention']}, {'type': 'SHAM_COMPARATOR', 'label': 'Usual Care', 'description': 'Stroke survivors randomized to this group will receive standard occupational and physical therapy.', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'StrokeWear Motor and Behavioral Intervention', 'type': 'COMBINATION_PRODUCT', 'description': 'The intervention will consist of 1) the use of StrokeWear for goal directed movements (GDM) feedback and goal setting, 2) use of daily activity action planning (DAAP) to foster planned hemiparetic UE use during daily activities in the home and community, and 3) patient empowerment. Patient empowerment in this study will occur over 6-months as patients gain the ability to use the StrokeWear technology independently and develop skills to manage their GDM and DAAP.', 'armGroupLabels': ['StrokeWear Motor and Behavioral Intervention']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'The intervention will consist in a sham version of the StrokeWear system and usual clinical care under the direction of a clinician. The sham version of the StrokeWear system will include sensing and recording technology to detect GDMs. However, study participants will not receive feedback from the system regarding the GDM counts.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paolo Bonato, PhD', 'role': 'CONTACT', 'email': 'pbonato@partners.org', 'phone': '617-952-6319'}, {'name': 'Paolo Bonato, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spaulding Rehabilitation Hospital Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Paolo Bonato, PhD', 'role': 'CONTACT', 'email': 'pbonato@partners.org', 'phone': '617-952-6319'}], 'overallOfficials': [{'name': 'Paolo Bonato, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spaulding Rehabilitation Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'BioSensics', 'class': 'INDUSTRY'}, {'name': 'MGH Institute of Health Professions', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Motion Analysis Laboratory', 'investigatorFullName': 'Paolo Bonato', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}