Clinical trial NCT04297774: Effects of Wearable Sensor Based Virtual Reality Game on Balance for Stroke
Official title: Effects of Wearable Sensor Based Virtual Reality Game on Balance 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: 40
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: Pablo is a new virtual reality (VR) game combined with wearable motion sensor system which can targeted intervention in an interactive environment, immediate and sensitive feedback about the user's performance, a motivating effect due to game-based feature. Unlike commercial camera systems such as Kinect or force platforms, the systems require a continuous sightline or restrict the base of support which may increase risk of falling. Few of studies had investigated the rehabilitation effects on balance with Pablo for patients with stroke. The purpose of this study is to investigate the effects of virtual reality training through Pablo system in patients with chronic stroke.

Detailed description: Pablo is a new virtual reality (VR) game combined with wearable motion sensor system which can targeted intervention in an interactive environment, immediate and sensitive feedback about the user's performance, a motivating effect due to game-based feature. Unlike commercial camera systems such as Kinect or force platforms, the systems require a continuous sightline or restrict the base of support which may increase risk of falling. Few of studies had investigated the rehabilitation effects on balance with Pablo for patients with stroke.

PURPOSE: The purpose of this study is to investigate the effects of virtual reality training through Pablo system in patients with chronic stroke.

METHODS: A prospective, randomized, controlled, blinded assessor design was used. Patients with stroke were recruited and randomly assigned to a "virtual reality(VR) group" (n = 20) and "functional balance training (FBT) group" (n = 20). After 18 training sessions (60 minutes per session, 2 sessions per week), outcome measures which included the Berg Balance Scale, the Timed Up and Go Test (cognition), a gait analysis, the Activities-Specific Balance Confidence scale, Stroke Impact Scale (SIS), Level of pleasure, and frequency of adverse events. The data were analyzed using nonparametric tests, and significance was indicated at α \< 0.05.

Eligibility criteria: Inclusion Criteria:

* Patients were included if they had first stroke with hemiplegia.
* Could stand for 5 minutes without support.
* Chronicity of \>6 months.
* Could understand instructions.
* Brunnstrom stage of LE ≥Ⅲ.

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.

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Change from Baseline to 9 weeks follow up
Secondary outcomes:
measure: Functional reach test
timeFrame: Change from Baseline to 9 weeks follow up
measure: Time up and go-cognition
timeFrame: Change from Baseline to 9 weeks follow up
measure: Activities-specific Balance Confidence scale
timeFrame: Change from Baseline to 9 weeks follow up
measure: Stroke Impact Scale-physical domain
timeFrame: Change from Baseline to 9 weeks follow up
measure: Modified Physical Activity Enjoyment Scale
timeFrame: Every training session during 18 sessions, total sessions continued to 9 weeks
measure: Adverse event times
timeFrame: Every training session during 18 sessions, total sessions continued to 9 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
Study officials:
affiliation: Taipei Medical University, Taiwan, R.O.C.
name: Hsinchieh Lee, master
role: PRINCIPAL_INVESTIGATOR
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