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Clinical Trials/NCT03618732
NCT03618732
Completed
Not Applicable

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

Shatin Hospital0 sites93 target enrollmentAugust 3, 2015
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Shatin Hospital
Enrollment
93
Primary Endpoint
Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 4 weeks
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 3, 2015
End Date
February 1, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shatin Hospital
Responsible Party
Principal Investigator
Principal Investigator

Lam So Ling, Stefanie

Principal Investigator

Shatin Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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

  • Action Research Arm Test (ARAT) baseline to followup(Change from baseline to 12 weeks (4 weeks after training ended))
  • Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 8 weeks(Change from baseline to 8 weeks)
  • Action Research Arm Test (ARAT) baseline to 8 weeks(Change from baseline to 8 weeks)
  • Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 4 weeks(Change from baseline to 4 weeks)
  • Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to followup(Change from baseline to 12 weeks (4 weeks after training ended))
  • Action Research Arm Test (ARAT) baseline to 4 weeks(Change from baseline to 4 weeks)

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