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Effects of Virtual Reality Game on Upper Extremity Function for Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
virtual reality game traning
standard treatment
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • First stroke with hemiplegia,
  • Chronicity of >6 months
  • Could understand instructions
  • Brunnstrom stage of UE ≥IV.

Exclusion Criteria:

  • Patients who were aged <20 years and >75 years
  • Patients with visual or auditory impairment who were unable to see or hear the feedback from the device clearly
  • Montreal Cognitive Assessment <16
  • Modified Ashworth Scale score of >2
  • Patients with other medical symptoms that can affect movement were excluded.

Sites / Locations

  • Taipei Medical University Shuang Ho Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

virtual reality group

standard treatment group

Arm Description

Standard treatment 30 minutes plus virtual reality game 30 minutes, twice a week for 9 weeks.

Standard treatment 60 minutes, twice a week for 9 weeks.

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment-upper extremity
The Fugl-Meyer Assessment-upper extremity (FMA-UE) measures motor impairment in the upper extremity. The assessment consists of 33 items, including movement, reflex, grasp, and coordination, and a total score of 66.

Secondary Outcome Measures

Box and block test
The Box and block test (BBT) measures unilateral gross manual dexterity. The BBT score denotes the number of blocks transferred within 60 s.
Dynanometer
The grip dynamometer was used to measure the maximum isometric strength of the hand and forearm muscles. The mean score of 3 trials was calculated. For this measurement, the elbow was placed at 90° and the forearm was placed in mid-position.
Active range of motion of shoulder and elbow
The active range of motion of shoulder and elbow were measured through pablo system.
Stroke Impact Scale
The Stroke Impact Scale (SIS) is a quality of life measure designed specifically for patients with stroke. The instrument is a self-report questionnaire assessing eight domains: strength, hand function, activities of daily living (ADL)/instrumental ADL (IADL), mobility, communication, emotion, memory and thinking, and social participation.
Modified Physical Activity Enjoyment Scale
It is an scale that assesses enjoyment for physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" using a 7-point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate it).
Adverse effect times
To record the adverse effect times during the therapy.

Full Information

First Posted
March 2, 2020
Last Updated
September 23, 2021
Sponsor
Taipei Medical University Shuang Ho Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04296032
Brief Title
Effects of Virtual Reality Game on Upper Extremity Function for Stroke
Official Title
Effects of Wearable Sensor Based Virtual Reality Game on Upper Extremity Function for Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 2, 2020 (Actual)
Primary Completion Date
June 25, 2021 (Actual)
Study Completion Date
July 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Virtual reality training had already been used in stroke rehabilitation, and previous studies supported that it could improve upper extremity ability and increase motivation and pleasure than conventional methods. Pablo is a new VR game combined with motion sensor system which can detect subject's activities. Unlike commercial camera systems such as Kinect or XBOX, the systems require a continuous sightline or enough active range of motion which may increase risk of compensatory movement. Few of studies had investigated the rehabilitation effects on upper extremity with Pablo for patients with stroke.The purpose of this study is to investigate the effects of virtual reality upper extremity training through Pablo system in patients with chronic stroke.
Detailed Description
PURPOSE: The purpose of this study is to investigate the effects of virtual reality upper extremity training through Pablo system in patients with chronic stroke. METHODS:Patients with mild to moderate motor deficits were recruited and randomly assigned to "VR plus standard rehabilitation group"(n=19), and "standard rehabilitation group" (n=19). After 12 training sessions (60 minutes a time, 2 times a week), the performance was assessed by a blinded assessor. The outcome measures included Fugl-Meyer Assessment-Upper Limb section(FMAUE), Box and block test(BBT), Dynanometer, active range of motion of shoulder and elbow,and Stroke Impact Scale.Modified Physical Activity Enjoyment Scale and adverse effect were recorded after each sessions.Collected data will be analyzed with sample T test by SPSS version 20.0, and alpha level was set at 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
virtual reality group
Arm Type
Experimental
Arm Description
Standard treatment 30 minutes plus virtual reality game 30 minutes, twice a week for 9 weeks.
Arm Title
standard treatment group
Arm Type
Active Comparator
Arm Description
Standard treatment 60 minutes, twice a week for 9 weeks.
Intervention Type
Behavioral
Intervention Name(s)
virtual reality game traning
Intervention Description
The controllers were attached to upper extremity to control the game. The game could train the shoulder, elbow, and wrist control.
Intervention Type
Behavioral
Intervention Name(s)
standard treatment
Intervention Description
The program included bilateral hand, grasp/release, and pinch activities.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment-upper extremity
Description
The Fugl-Meyer Assessment-upper extremity (FMA-UE) measures motor impairment in the upper extremity. The assessment consists of 33 items, including movement, reflex, grasp, and coordination, and a total score of 66.
Time Frame
Change from Baseline at 9 weeks
Secondary Outcome Measure Information:
Title
Box and block test
Description
The Box and block test (BBT) measures unilateral gross manual dexterity. The BBT score denotes the number of blocks transferred within 60 s.
Time Frame
Change from Baseline at 9 weeks
Title
Dynanometer
Description
The grip dynamometer was used to measure the maximum isometric strength of the hand and forearm muscles. The mean score of 3 trials was calculated. For this measurement, the elbow was placed at 90° and the forearm was placed in mid-position.
Time Frame
Change from Baseline at 9 weeks
Title
Active range of motion of shoulder and elbow
Description
The active range of motion of shoulder and elbow were measured through pablo system.
Time Frame
Change from Baseline at 9 weeks
Title
Stroke Impact Scale
Description
The Stroke Impact Scale (SIS) is a quality of life measure designed specifically for patients with stroke. The instrument is a self-report questionnaire assessing eight domains: strength, hand function, activities of daily living (ADL)/instrumental ADL (IADL), mobility, communication, emotion, memory and thinking, and social participation.
Time Frame
Change from Baseline at 9 weeks
Title
Modified Physical Activity Enjoyment Scale
Description
It is an scale that assesses enjoyment for physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" using a 7-point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate it).
Time Frame
Every training session during 18 sessions, total sessions continued to 9 weeks
Title
Adverse effect times
Description
To record the adverse effect times during the therapy.
Time Frame
Every training session during 18 sessions, total sessions continued to 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First stroke with hemiplegia, Chronicity of >6 months Could understand instructions Brunnstrom stage of UE ≥IV. Exclusion Criteria: Patients who were aged <20 years and >75 years Patients with visual or auditory impairment who were unable to see or hear the feedback from the device clearly Montreal Cognitive Assessment <16 Modified Ashworth Scale score of >2 Patients with other medical symptoms that can affect movement were excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsinchieh Lee
Organizational Affiliation
Taipei Medical University, Taiwan, R.O.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University Shuang Ho Hospital
City
New Taipei City
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Effects of Virtual Reality Game on Upper Extremity Function for Stroke

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