Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-27 @ 4:13 AM
Study NCT ID:
NCT03618732
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2017-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial of Bilateral Movement-based Computer Games Training to Improve Motor Function of Upper Limb and Quality of Life in Sub-acute Stroke Patient
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'stratified, single-blinded, intervention and controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-05', 'studyFirstSubmitDate': '2017-10-06', 'studyFirstSubmitQcDate': '2018-08-05', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 4 weeks', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA-UE scores measure motor impairment of upper extremity. The motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist and hand.'}, {'measure': 'Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 8 weeks', 'timeFrame': 'Change from baseline to 8 weeks', 'description': 'The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA-UE scores measure motor impairment of upper extremity. The motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist and hand.'}, {'measure': 'Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to followup', 'timeFrame': 'Change from baseline to 12 weeks (4 weeks after training ended)', 'description': 'The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA-UE scores measure motor impairment of upper extremity. The motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist and hand.'}], 'secondaryOutcomes': [{'measure': 'Action Research Arm Test (ARAT) baseline to 4 weeks', 'timeFrame': 'Change from baseline to 4 weeks', 'description': "The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia. It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation."}, {'measure': 'Action Research Arm Test (ARAT) baseline to 8 weeks', 'timeFrame': 'Change from baseline to 8 weeks', 'description': "The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia. It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation."}, {'measure': 'Action Research Arm Test (ARAT) baseline to followup', 'timeFrame': 'Change from baseline to 12 weeks (4 weeks after training ended)', 'description': "The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia. It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation."}, {'measure': 'Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 4 weeks', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'The Short-Form Health Survey (SF-36) is a widely used, generic, patient-report measure created to assess health-related quality of life (HRQOL) in the general population. SF-36 is the most commonly used generic instrument for measuring quality of life.'}, {'measure': 'Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 8 weeks', 'timeFrame': 'Change from baseline to 8 weeks', 'description': 'The Short-Form Health Survey (SF-36) is a widely used, generic, patient-report measure created to assess health-related quality of life (HRQOL) in the general population. SF-36 is the most commonly used generic instrument for measuring quality of life.'}, {'measure': 'Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to followup', 'timeFrame': 'Change from baseline to 12 weeks (4 weeks after training ended)', 'description': 'The Short-Form Health Survey (SF-36) is a widely used, generic, patient-report measure created to assess health-related quality of life (HRQOL) in the general population. SF-36 is the most commonly used generic instrument for measuring quality of life.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'upper limb', 'motor control', 'function', 'bilateral movement', 'virtual reality'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This study aims at investigating whether bilateral movement-based training with computer games could augment motor function of paretic upper limb and improve quality of life in sub-acute stroke patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 45-85\n* Diagnosis of ischaemic brain injury or intracerebral hemorrhage by MRI or computed tomography 1 week to 6 months after the onset of current stroke\n* Scoring \\> 6 of 10 of Abbreviated Mental Test\n* Ability of the paretic hand to hold the game controller (minimal control)\n* Able to give informed consent of the study\n* Can understand instructions given by English or Cantonese\n\nExclusion Criteria:\n\n* Any additional medical, cardiovascular and orthopaedic condition that would hinder the proper assessment and treatment\n* Having cardiac pacemaker\n* Receptive dysphasia\n* Undergoing drug studies or other clinical trials'}, 'identificationModule': {'nctId': 'NCT03618732', 'briefTitle': 'A Randomized Controlled Trial of Bilateral Movement-based Computer Games Training to Improve Motor Function of Upper Limb and Quality of Life in Sub-acute Stroke Patient', 'organization': {'class': 'OTHER', 'fullName': 'Shatin Hospital'}, 'officialTitle': 'A Randomized Controlled Trial of Bilateral Movement-based Computer Games Training to Improve Motor Function of Upper Limb and Quality of Life in Sub-acute Stroke Patient', 'orgStudyIdInfo': {'id': 'HMRF02133096'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bilateral movement-based computer training', 'description': 'All subjects underwent 16 sessions of assigned treatment (2 times per week; for 8 weeks; 3 hours standardized rehabilitation program per visit) There was 1.5 hours standardized conventional physiotherapy training a 1.5 hours multi-disciplinary program which consisted of standardized occupational therapy, speech therapy and nursing care.\n\nSubjects in Intervention Group will be assigned an additional 30 minutes bilateral movement-based computer games(Able-X) training program of upper limb.', 'interventionNames': ['Other: Bilateral movement-based computer training']}, {'type': 'OTHER', 'label': 'Video-directed conventional training', 'description': 'All subjects underwent 16 sessions of assigned treatment (2 times per week; for 8 weeks; 3 hours standardized rehabilitation program per visit) There was 1.5 hours standardized conventional physiotherapy training a 1.5 hours multi-disciplinary program which consisted of standardized occupational therapy, speech therapy and nursing care.', 'interventionNames': ['Other: Video-directed conventional training']}], 'interventions': [{'name': 'Bilateral movement-based computer training', 'type': 'OTHER', 'armGroupLabels': ['Bilateral movement-based computer training']}, {'name': 'Video-directed conventional training', 'type': 'OTHER', 'armGroupLabels': ['Video-directed conventional training']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shatin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lam So Ling, Stefanie', 'investigatorAffiliation': 'Shatin Hospital'}}}}