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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Stroke

Intervention / Treatment
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* Other: Bilateral movement-based computer training
* Other: Video-directed conventional training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 45-85 Diagnosis of ischaemic brain injury or intracerebral hemorrhage by MRI or computed tomography 1 week to 6 months after the onset of current stroke Scoring > 6 of 10 of Abbreviated Mental Test Ability of the paretic hand to hold the game controller (minimal control) Able to give informed consent of the study Can understand instructions given by English or Cantonese Exclusion Criteria: Any additional medical, cardiovascular and orthopaedic condition that would hinder the proper assessment and treatment Having cardiac pacemaker Receptive dysphasia Undergoing drug studies or other clinical trials

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: stratified, single-blinded, intervention and controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral movement-based computer training<br>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. Subjects in Intervention Group will be assigned an additional 30 minutes bilateral movement-based computer games(Able-X) training program of upper limb. | Other: Bilateral movement-based computer training<br> <br> |
| Other: Video-directed conventional training<br>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. | Other: Video-directed conventional training<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 4 weeks | 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. | Change from baseline to 4 weeks | 
| Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 8 weeks | 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. | Change from baseline to 8 weeks | 
| Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to followup | 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. | Change from baseline to 12 weeks (4 weeks after training ended) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test (ARAT) baseline to 4 weeks | 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. | Change from baseline to 4 weeks | 
| Action Research Arm Test (ARAT) baseline to 8 weeks | 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. | Change from baseline to 8 weeks | 
| Action Research Arm Test (ARAT) baseline to followup | 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. | Change from baseline to 12 weeks (4 weeks after training ended) | 
| Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 4 weeks | 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. | Change from baseline to 4 weeks | 
| Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 8 weeks | 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. | Change from baseline to 8 weeks | 
| Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to followup | 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. | Change from baseline to 12 weeks (4 weeks after training ended) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, upper limb, motor control, function, bilateral movement, virtual reality