Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-11 @ 5:32 PM
Study NCT ID:
NCT03084705
Status:
COMPLETED
Last Update Posted:
2021-03-29
First Post:
2017-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wearable Device for Motivating Hand Use After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-15', 'releaseDate': '2024-09-20'}, {'resetDate': '2025-05-09', 'releaseDate': '2025-04-24'}, {'resetDate': '2025-07-22', 'releaseDate': '2025-07-02'}], 'estimatedResultsFirstSubmitDate': '2024-09-20'}}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-24', 'studyFirstSubmitDate': '2017-03-14', 'studyFirstSubmitQcDate': '2017-03-14', 'lastUpdatePostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Box and Blocks Test (BBT)', 'timeFrame': '3 months', 'description': 'To measure unilateral gross manual dexterity'}], 'secondaryOutcomes': [{'measure': 'Action Research Arm Test (ARAT)', 'timeFrame': '3 months', 'description': 'To evaluate specific changes in arm function from handling objects differing in size, weight and shape'}, {'measure': 'Fugl-Meyer Motor Assessment (FM)', 'timeFrame': '3 months', 'description': 'To assess motor functioning, balance, joint functioning thru performance based movement'}, {'measure': 'Motor Activity Log (MAL)', 'timeFrame': '3 months', 'description': 'To evaluate self-reported functional use of the limb'}, {'measure': 'Amount of upper extremity activity', 'timeFrame': '3 months', 'description': 'To evaluate the daily amount of upper extremity activity by using the wearable sensor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Stroke']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine the effectiveness of interactive feedback from a wearable device that senses hand function, the Manumeter, in improving upper extremity function in a pilot, randomized controlled trial with chronic stroke patients', 'detailedDescription': 'In this randomized controlled trial, the investigators will compare two groups of chronic stroke participants Group 1 of study participants will use the Manumeter with interactive functions to monitor and motivate upper extremity functional activity. Group 2 of study participants will use the Manumeter but receive no feedback and will be given the current standard-of-care, a booklet describing a home exercise program for increasing upper extremity exercise. The investigators hypothesize that study participants who interactively monitor functional activity with the Manumeter will improve their upper extremity function significantly more.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 80 years of age\n* Experienced one or multiple strokes at least six months previously\n* Upper Extremity Fugl-Meyer Score \\< 60 out of 66\n* Absence of moderate to severe upper limb pain (\\< 3 on the a 10 point visual-analog pain scale)\n* Ability to understand the instructions to operate the device\n\nExclusion Criteria:\n\n* 80 years of age and above\n* Implanted pacemaker\n* moderate to severe pain in affected arm\n* severe tone in affected arm as measured on a standard clinical scale\n* language problem that would prevent from properly understanding instructions\n* currently pregnant\n* difficulty in understanding or complying with the instructions given by the experimenter\n* inability to perform the experimental task that will be studied'}, 'identificationModule': {'nctId': 'NCT03084705', 'briefTitle': 'Wearable Device for Motivating Hand Use After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'An Interactive, Wearable Device for Measuring and Motivating Hand Use After Stroke', 'orgStudyIdInfo': {'id': 'NIH HS# 2017-4119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Manumeter with interactive feedback', 'description': 'Study participants will receive an experimental manumeter and interactive feedback from the manumeter to monitor and motivate their upper extremity functional activities.', 'interventionNames': ['Device: Manumeter']}, {'type': 'EXPERIMENTAL', 'label': 'Manumeter without interactive feedback', 'description': 'Study participants will receive an experimental manumeter but receive no feedback from the manumeter, and will be given the current standard-of-care for increasing upper extremity exercise booklet to perform at home.', 'interventionNames': ['Device: Manumeter']}], 'interventions': [{'name': 'Manumeter', 'type': 'DEVICE', 'description': 'A manumeter is a first-of-its-kind magnetic sensor to wirelessly detect hand and arm movement in a socially acceptable and easy to don package. The study participants will wear a small magnet as a ring, and a sensing/logging wristband detects changes in the magnetic field as the ring moves; the wristband can detect arm accelerations.', 'armGroupLabels': ['Manumeter with interactive feedback', 'Manumeter without interactive feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'David Reinkensmeyer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'David Reinkensmeyer', 'investigatorAffiliation': 'University of California, Irvine'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-09-20', 'type': 'RELEASE'}, {'date': '2024-10-15', 'type': 'RESET'}, {'date': '2025-04-24', 'type': 'RELEASE'}, {'date': '2025-05-09', 'type': 'RESET'}, {'date': '2025-07-02', 'type': 'RELEASE'}, {'date': '2025-07-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'David Reinkensmeyer, Professor, University of California, Irvine'}}}}