Ignite Creation Date:
2025-12-24 @ 11:59 PM
Ignite Modification Date:
2026-01-25 @ 9:55 AM
Study NCT ID:
NCT06786858
Status:
RECRUITING
Last Update Posted:
2025-01-22
First Post:
2023-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hand Exoskeleton Training Study
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2025-01-15', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Upper Extremity (FMA-UE) Test', 'timeFrame': 'Change from baseline Fugl-Meyer score at 6 weeks', 'description': 'Evaluates and measures recovery in post-stroke hemiplegic patients. The FMA-UE Test will assess upper limb motor impairments for this study. It is a 33-item test that measures motor and reflex function in the upper body. Each item is scored on a scale of 0-2, with 0 indicating inability, 1 indicating beginning ability, and 2 indicating normal. The total score ranges from 0-66, highest score indicating no disability.'}, {'measure': 'Action Research Arm Test (ARAT)', 'timeFrame': 'Change from baseline ARAT score at 6 weeks', 'description': 'The ARAT is 19-item clinical assessment used to measure the functional ability of the upper extremity, particularly in individuals recovering from a stroke, by evaluating their performance on tasks like grasping, gripping, pinching, and gross arm movements. It is scored on a four-level ordinal scale (0-3). Highest score indicating normal movement.'}, {'measure': 'Motor Activity Log', 'timeFrame': 'Change from baseline MAL score at 6 weeks', 'description': 'The Motor Activity Log will be used to assess use of the limb at home. Respondents rate how they use their more-impaired arm for activities of daily living (ADLs) in the home (brushing teeth, buttoning a shirt, etc.).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': "The goal of this study is to evaluate the HandMATE device's effectiveness in the rehabilitation of stroke patients and asses if the HandMATE application is received well by stroke survivors.\n\nParticipants will use the HandMate device in clinic and in the home. They will also complete clinical upper extremity assessments.", 'detailedDescription': 'This study will evaluate the effectiveness of novel device and its potential to help stroke victims regain functional use of their hand and regain independent living. The study will also evaluate the potential of the device to be used at home, this would allow increased therapy intensity and decreased overall treatment costs (fewer therapist hours required and decreased travel costs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 21 or older\n* diagnosis of stroke more than 6 months prior confirmed from MRI or CT\n* voluntary hand activity (score of 1 or more, finger extension item, Fugl-Meyer Test)\n* adequate cognitive status\n* Impaired ability to open affected hand\n\nExclusion Criteria:\n\n* hemispatial neglect\n* severe sensory loss (2 or more on the sensory item, NIH Stroke Scale/Score)\n* receiving or planning to receive antispasticity medications during enrollment into the study\n* less than full passive range of motion in finger joints\n* receiving physical or occupational therapy outside of study protocols\n* have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols'}, 'identificationModule': {'nctId': 'NCT06786858', 'acronym': 'HandMATE', 'briefTitle': 'Hand Exoskeleton Training Study', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'Home Training for Upper Limb Stroke Rehabilitation Using a Hand Exoskeleton', 'orgStudyIdInfo': {'id': '00004431'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HandMate Use', 'description': 'HandMate device fitted for a stroke participant.', 'interventionNames': ['Device: HandMate']}], 'interventions': [{'name': 'HandMate', 'type': 'DEVICE', 'description': 'HandMate device is used for 20 hours in 4 weeks. Device is then used in the home for 3 months at discretion of participant.', 'armGroupLabels': ['HandMate Use']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan L Grainger', 'role': 'CONTACT', 'email': 'megan.l.grainger@medstar.net', 'phone': '202-877-1464'}], 'facility': 'MedStar National Rehabilitation Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'centralContacts': [{'name': 'Megan L Grainger', 'role': 'CONTACT', 'email': 'megan.l.grainger@medstar.net', 'phone': '2028771464'}], 'overallOfficials': [{'name': 'Pete Lum, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MedStar RI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}