Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-29 @ 12:35 AM
Study NCT ID:
NCT01157195
Status:
COMPLETED
Last Update Posted:
2018-09-28
First Post:
2010-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], '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'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-26', 'studyFirstSubmitDate': '2010-06-17', 'studyFirstSubmitQcDate': '2010-07-02', 'lastUpdatePostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Motor Activity Log (MAL) Arm Use Scale at 2 weeks', 'timeFrame': 'Baseline to 2 weeks (average)', 'description': 'Well-validated structured interview that assesses how much and how well the more-affected arm after stroke has been used to accomplish everyday activities over a specified period.'}], 'secondaryOutcomes': [{'measure': 'Change in Wolf Motor Function Test (WMFT) Performance Rate at 2 weeks', 'timeFrame': 'Baseline to 2 weeks (average)', 'description': 'Well-validated laboratory motor performance test that assesses how quickly an individual can perform upper-extremity tasks with the more-affected arm after stroke.'}, {'measure': 'Change in MAL Arm Use Scale at 6 months', 'timeFrame': 'Baseline to 6 months (average)', 'description': 'See primary outcome.'}, {'measure': 'Change in MAL Arm Use Scale at 12 months', 'timeFrame': 'Baseline to 12 months (average)', 'description': 'See primary outcome.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stroke', 'chronic', 'arm', 'rehabilitation', 'tele-health'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '10659807', 'type': 'BACKGROUND', 'citation': 'Taub E, Uswatte G, Pidikiti R. Constraint-Induced Movement Therapy: a new family of techniques with broad application to physical rehabilitation--a clinical review. J Rehabil Res Dev. 1999 Jul;36(3):237-51.'}]}, 'descriptionModule': {'briefSummary': 'Constraint-Induced Movement therapy, also known as CI therapy, is an approach to physical rehabilitation derived from basic behavioral and neuroscience research. It has been shown to be efficacious for rehabilitating use of the more-affected arm in individuals more than one year after stroke with mild to moderate motor impairment. The first component of the therapy is intensive training in use of the more-affected arm on functional tasks for 3 hours daily for 10 consecutive weekdays. The second is wearing a protective safety mitt on the less-affected hand for all waking hours of the approximately 2-week treatment period that it is safe to do so. The purpose of the mitt is to discourage use of the less-affected arm. The third is a group of behavioral techniques designed to transfer gains from the treatment setting to the real world, which takes a therapist, on average, 30 minutes to implement on each treatment day.\n\nThe purpose of this project is to develop and test a method for automating the delivery of this efficacious treatment in a way that the therapy can be provided in stroke patients\' homes. After developing an automated CI therapy workstation that has tele-health capabilities, the investigators will conduct a randomized controlled trial to evaluate whether CI therapy delivered in the home using this workstation with remote supervision by a therapist via an Internet-based audiovisual link provides outcomes that are just as good as CI therapy delivered by a "live" therapist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more than 1 year after stroke\n* some ability to voluntarily open fingers on more affected side of body\n* some ability to voluntarily raise wrist on more affected side of body\n* ability to stand independently for two minutes\n* ability to transfer from sit to stand independently\n\nExclusion Criteria:\n\n* serious, concurrent medical conditions including frailty\n* excessive spasticity (high muscle tone) in more affected arm\n* impairment in thinking that makes compliance with study activities difficult'}, 'identificationModule': {'nctId': 'NCT01157195', 'briefTitle': 'Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation', 'orgStudyIdInfo': {'id': 'F071227003'}, 'secondaryIdInfos': [{'id': 'R01HD053750', 'link': 'https://reporter.nih.gov/quickSearch/R01HD053750', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CI therapy', 'interventionNames': ['Behavioral: CI therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Tele-AutoCITE', 'description': 'AutoCITE stands for Automated Constraint Induced Therapy Extender.', 'interventionNames': ['Behavioral: Tele-AutoCITE']}], 'interventions': [{'name': 'Tele-AutoCITE', 'type': 'BEHAVIORAL', 'description': 'Automated, remotely-administered form of CI therapy', 'armGroupLabels': ['Tele-AutoCITE']}, {'name': 'CI therapy', 'type': 'BEHAVIORAL', 'description': 'CI therapy is a behavioral approach to physical rehabilitation that has three components: 1. intense training of the more affected arm for several hours daily for multiple consecutive days, 2. restraint of the less affected arm during training hours and afterwards during the treatment period, 3. A package of behavioral techniques designed to transfer gains from the treatment setting to daily life. In this trial, CI therapy will be administered for 3 1/2 hours per day for 10 consecutive weekdays.', 'armGroupLabels': ['CI therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Gitendra Uswatte, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Psychology Department, University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychology', 'investigatorFullName': 'Gitendra Uswatte', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}