Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-05 @ 6:18 PM
Study NCT ID:
NCT03005457
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2016-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Assess the Feasibility and Initial Efficacy of Therapist-as-consultant, Game-based CI Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-25', 'studyFirstSubmitDate': '2016-12-21', 'studyFirstSubmitQcDate': '2016-12-25', 'lastUpdatePostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Motor Activity Log', 'timeFrame': 'Week 0 and Week 3', 'description': 'Self-report measure of arm use for daily activities'}, {'measure': 'Change in Wolf Motor Function Test', 'timeFrame': 'Week 0 and Week 3', 'description': 'Objective measure of motor function in a laboratory setting'}], 'secondaryOutcomes': [{'measure': 'Kinematic Data', 'timeFrame': 'Week 0 and Week 3', 'description': 'Kinematic data recorded during game play'}, {'measure': 'Brief Kinesthesia test', 'timeFrame': 'Week 0 and Week 3', 'description': 'Clinical Assessment of sensation'}, {'measure': 'Patient Health Questionnaire', 'timeFrame': 'Week 0 and Week 3', 'description': 'Measures Depression'}, {'measure': 'Strok Specific Quality of Life Scale', 'timeFrame': 'Week 0 and Week 3', 'description': 'Quality of life measurement'}, {'measure': 'Weschler Adult Intelligence Scale Symbol Seach', 'timeFrame': 'Week 0 and Week 3', 'description': 'Cognitive processing speed assessment'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': 'Week 0 and Week 3', 'description': 'Baseline cognitive screen'}, {'measure': 'Survey', 'timeFrame': 'Week 0 and Week 3', 'description': 'Survey on satisfaction with the intervention'}, {'measure': 'Mitt Compliance', 'timeFrame': 'Week 0 and Week 3', 'description': 'Hours of use'}, {'measure': 'Total game-play time', 'timeFrame': 'Week 0 and Week 3'}, {'measure': 'Gestures', 'timeFrame': 'Week 0 and Week 3', 'description': 'Number of gestures of each type registered in game'}, {'measure': 'Bilateral activity monitors', 'timeFrame': 'Week 0 and Week 3', 'description': 'Objective measure of arm use'}, {'measure': 'Action Research Arm Test (ARAT)', 'timeFrame': 'Week 0 and Week 3', 'description': 'Asses Changes in Limb Function'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke', 'Hemiparesis', 'Upper Extremity Dysfunction']}, 'referencesModule': {'references': [{'pmid': '30246613', 'type': 'DERIVED', 'citation': 'Kelly KM, Borstad AL, Kline D, Gauthier LV. Improved quality of life following constraint-induced movement therapy is associated with gains in arm use, but not motor improvement. Top Stroke Rehabil. 2018 Oct;25(7):467-474. doi: 10.1080/10749357.2018.1481605. Epub 2018 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'Pilot study to assess the feasibility and initial efficacy of therapist-as-consultant, game-based CI therapy. Pre/post study design. Participant received a target of 30 hours game-based motor intervention, 100 hours constraint of the less affected upper extremity, and 5 hours therapist consultation (including completion of a behavioral contract at the first study visit). Duration of intervention was 10 consecutive weekdays, with pre-treatment and post-treatment testing performed within 1 week prior to and 1 week post-intervention by an independent tester.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide signed and dated informed consent form\n* Willing to comply with all study procedures and be available for the duration of the study\n* Male or female aged \\> 17\n* Preserved ability to comprehend English and participate in basic elements of the therapy\n* Community-dwelling\n* Experienced mild to moderate hemiparesis at least six months prior\n* Can independently operate the gaming system (those with severe cognitive impairments can usually achieve this)\n* Corrected vision of at least 20/70 as assessed by their ability to identify game objects on the monitor from 5 feet away\n\nExclusion Criteria:\n\n* concurrent participation in other experimental upper extremity trials\n* concurrent participation in other outpatient rehabilitation for their upper extremity\n* Botox within the last 3 months (confound)\n* near-normal motor function (9-hole Peg Test score above the 10th percentile of a normative sample)\n* minimal nonuse (Motor Activity Log at baseline \\>2.5, Accelerometry \\> 60%)\n* major medical issues that would interfere with study treatments or make intensive rehabilitation difficult to tolerate'}, 'identificationModule': {'nctId': 'NCT03005457', 'briefTitle': 'Pilot Study to Assess the Feasibility and Initial Efficacy of Therapist-as-consultant, Game-based CI Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'A Low-cost Virtual Reality Gaming Platform for Neurorehabilitation of Hemiparesis', 'orgStudyIdInfo': {'id': '60047824'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stroke', 'interventionNames': ['Behavioral: Hemiparesis Therapy with VR']}, {'type': 'EXPERIMENTAL', 'label': 'Hemiparesis other', 'interventionNames': ['Behavioral: Hemiparesis Therapy with VR']}], 'interventions': [{'name': 'Hemiparesis Therapy with VR', 'type': 'BEHAVIORAL', 'description': 'An in-home therapist-as-consultant model of CI therapy in which motor practice with shaping and the Motor Activity Log with problem solving were delivered via a custom avatar-based video game called Recovery Rapids', 'armGroupLabels': ['Hemiparesis other', 'Stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University, 2154 Dodd Hall', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Will be shared upon publication acceptance.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nationwide Children', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Prof. PM&R', 'investigatorFullName': 'Lynne Gauthier , PhD', 'investigatorAffiliation': 'Ohio State University'}}}}