Skip to main content
OpenTrials
Completed

NCT Number: NCT03618732

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilateral movement-based computer training

Other

Video-directed conventional training

Other

Primary outcomes

  1. Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 4 weeks

    Time frame: Change from 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.

  2. Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 8 weeks

    Time frame: Change from 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.

  3. Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to followup

    Time frame: Change 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 outcomes

  1. Action Research Arm Test (ARAT) baseline to 4 weeks

    Time frame: Change from 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.

  2. Action Research Arm Test (ARAT) baseline to 8 weeks

    Time frame: Change from 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.

  3. Action Research Arm Test (ARAT) baseline to followup

    Time frame: Change 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.

  4. Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 4 weeks

    Time frame: Change from 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.

  5. Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 8 weeks

    Time frame: Change from 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.

  6. Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to followup

    Time frame: Change 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.

Sponsors and collaborators

Lead sponsor

Shatin Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 7, 2018
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.