Clinical trial NCT04296032: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Fugl-Meyer Assessment-upper extremity
timeFrame: Change from Baseline at 9 weeks
Secondary outcomes:
measure: Box and block test
timeFrame: Change from Baseline at 9 weeks
measure: Dynanometer
timeFrame: Change from Baseline at 9 weeks
measure: Active range of motion of shoulder and elbow
timeFrame: Change from Baseline at 9 weeks
measure: Stroke Impact Scale
timeFrame: Change from Baseline at 9 weeks
measure: Modified Physical Activity Enjoyment Scale
timeFrame: Every training session during 18 sessions, total sessions continued to 9 weeks
measure: Adverse effect times
timeFrame: Every training session during 18 sessions, total sessions continued to 9 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
Study officials:
affiliation: Taipei Medical University, Taiwan, R.O.C.
name: Hsinchieh Lee
role: PRINCIPAL_INVESTIGATOR
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