Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-01 @ 10:43 PM
Study NCT ID:
NCT04296032
Status:
COMPLETED
Last Update Posted:
2021-09-24
First Post:
2020-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Virtual Reality Game on Upper Extremity Function for Stroke
Sponsor:
Taipei Medical University Shuang Ho Hospital
Organization:
Study Overview
Official Title:
Effects of Wearable Sensor Based Virtual Reality Game on Upper Extremity Function for Patients With Stroke
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: