Effects of Virtual Reality Game on Upper Extremity Function for Stroke

September 23, 2021 updated by: Taipei Medical University Shuang Ho Hospital

Effects of Wearable Sensor Based Virtual Reality Game on Upper Extremity Function for Patients With Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan
        • Taipei Medical University Shuang Ho Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: virtual reality group
Standard treatment 30 minutes plus virtual reality game 30 minutes, twice a week for 9 weeks.
Behavioral: virtual reality game traning
The controllers were attached to upper extremity to control the game. The game could train the shoulder, elbow, and wrist control.
Behavioral: standard treatment
The program included bilateral hand, grasp/release, and pinch activities.
ACTIVE_COMPARATOR: standard treatment group
Standard treatment 60 minutes, twice a week for 9 weeks.
Behavioral: standard treatment
The program included bilateral hand, grasp/release, and pinch activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment-upper extremity
Time Frame: Change from Baseline at 9 weeks
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.
Change from Baseline at 9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and block test
Time Frame: Change from Baseline at 9 weeks
The Box and block test (BBT) measures unilateral gross manual dexterity. The BBT score denotes the number of blocks transferred within 60 s.
Change from Baseline at 9 weeks
Dynanometer
Time Frame: Change from Baseline at 9 weeks
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.
Change from Baseline at 9 weeks
Active range of motion of shoulder and elbow
Time Frame: Change from Baseline at 9 weeks
The active range of motion of shoulder and elbow were measured through pablo system.
Change from Baseline at 9 weeks
Stroke Impact Scale
Time Frame: Change from Baseline at 9 weeks
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.
Change from Baseline at 9 weeks
Modified Physical Activity Enjoyment Scale
Time Frame: Every training session during 18 sessions, total sessions continued to 9 weeks
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).
Every training session during 18 sessions, total sessions continued to 9 weeks
Adverse effect times
Time Frame: Every training session during 18 sessions, total sessions continued to 9 weeks
To record the adverse effect times during the therapy.
Every training session during 18 sessions, total sessions continued to 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Investigators

  • Principal Investigator: Hsinchieh Lee, Taipei Medical University, Taiwan, R.O.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2020

Primary Completion (ACTUAL)

June 25, 2021

Study Completion (ACTUAL)

July 25, 2021

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (ACTUAL)

March 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMU-JIRB N201912049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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