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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618732
• Other study ID #: HMRF02133096
• Status: Completed
• Phase: N/A
• Start date: August 3, 2015
• Est. completion date: February 1, 2017

Study information

• Verified date: August 2018
• Source: Shatin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: February 1, 2017
• Est. primary completion date: February 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Bilateral movement-based computer training

• Video-directed conventional training

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shatin Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)