An interventional study of virtual reality game traning and standard treatment in Stroke, sponsored by Taipei Medical University Shuang Ho Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-09-24.
Sponsored by Taipei Medical University Shuang Ho Hospital · Not applicable, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 37 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Taipei Medical University Shuang Ho Hospital is the lead sponsor of 100 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard treatment 30 minutes plus virtual reality game 30 minutes, twice a week for 9 weeks.
Behavioral: virtual reality game traning · Behavioral: standard treatment
Standard treatment 60 minutes, twice a week for 9 weeks.
Behavioral: standard treatment
The controllers were attached to upper extremity to control the game. The game could train the shoulder, elbow, and wrist control.
The program included bilateral hand, grasp/release, and pinch activities.
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.
Time frame: Change from Baseline at 9 weeks
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.
Time frame: Change from Baseline at 9 weeks
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.
Time frame: Change from Baseline at 9 weeks
Active range of motion of shoulder and elbow
The active range of motion of shoulder and elbow were measured through pablo system.
Time frame: Change from Baseline at 9 weeks
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.
Time frame: Change from Baseline at 9 weeks
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).
Time frame: Every training session during 18 sessions, total sessions continued to 9 weeks
Adverse effect times
To record the adverse effect times during the therapy.
Time frame: Every training session during 18 sessions, total sessions continued to 9 weeks
Plan to share: No
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Taipei Medical University Shuang Ho Hospital