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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Bilateral movement-based computer training; Other: Video-directed conventional training

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bilateral movement-based computer training; 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
Other: Video-directed conventional training; 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Shatin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: October 6, 2017
• First Submitted That Met QC Criteria: August 5, 2018
• First Posted (Actual): August 7, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 5, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: stroke; function; upper limb; virtual reality; motor control; bilateral movement
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HMRF02133096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No