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Clinical Trials/NCT04296032
NCT04296032
Completed
Not Applicable

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

Taipei Medical University Shuang Ho Hospital1 site in 1 country37 target enrollmentMay 2, 2020
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Taipei Medical University Shuang Ho Hospital
Enrollment
37
Locations
1
Primary Endpoint
Fugl-Meyer Assessment-upper extremity
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2, 2020
End Date
July 25, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Taipei Medical University Shuang Ho Hospital
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Box and block test(Change from Baseline at 9 weeks)
  • Dynanometer(Change from Baseline at 9 weeks)
  • Stroke Impact Scale(Change from Baseline at 9 weeks)
  • Active range of motion of shoulder and elbow(Change from Baseline at 9 weeks)
  • Modified Physical Activity Enjoyment Scale(Every training session during 18 sessions, total sessions continued to 9 weeks)
  • Adverse effect times(Every training session during 18 sessions, total sessions continued to 9 weeks)

Study Sites (1)

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