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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03618732
Enrollment
93
Registered
2018-08-07
Start date
2015-08-03
Completion date
2017-02-01
Last updated
2018-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, upper limb, motor control, function, bilateral movement, virtual reality

Brief summary

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.

Interventions

OTHERVideo-directed conventional training
OTHERBilateral movement-based computer training

Sponsors

Shatin Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

stratified, single-blinded, intervention and controlled study

Eligibility

Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 4 weeksChange from baseline to 4 weeksThe 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.
Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 8 weeksChange from baseline to 8 weeksThe 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.
Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to followupChange from baseline to 12 weeks (4 weeks after training ended)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.

Secondary

MeasureTime frameDescription
Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 4 weeksChange from baseline to 4 weeksThe 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.
Action Research Arm Test (ARAT) baseline to 4 weeksChange from baseline to 4 weeksThe 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.
Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to followupChange from baseline to 12 weeks (4 weeks after training ended)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.
Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 8 weeksChange from baseline to 8 weeksThe 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.
Action Research Arm Test (ARAT) baseline to 8 weeksChange from baseline to 8 weeksThe 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.
Action Research Arm Test (ARAT) baseline to followupChange from baseline to 12 weeks (4 weeks after training ended)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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026