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

NCT03618732 | Completed

• 1 other identifier: HMRF02133096
• Study Type: interventional
• Target: 93
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Action Research Arm Test (ARAT) baseline to 4 weeks

  Change from baseline to 4 weeks

• Action Research Arm Test (ARAT) baseline to 8 weeks

  Change from baseline to 8 weeks

• 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 4 weeks

  Change from baseline to 4 weeks

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

  Change from baseline to 8 weeks

Study Arms (2)

Bilateral movement-based computer training

EXPERIMENTAL

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

Video-directed conventional training

OTHER

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

Interventions

Bilateral movement-based computer training OTHER

Bilateral movement-based computer training

Video-directed conventional training OTHER

Video-directed conventional training

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shatin Hospital: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: stratified, single-blinded, intervention and controlled study

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: August 7, 2018
• Study Start: August 3, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share