Effects of Wearable Sensor Based Virtual Reality Game on Balance for Stroke

Taipei Medical University

Status: Completed

Conditions: Stroke

Treatments: Behavioral: standard treatment; Behavioral: balance training; Behavioral: virtual reality treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04297774

TMU-JIRB N201912048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

virtual reality group

Experimental group

Description:

18 sessions of standard treatment plus virtual reality treatment.

Treatment:

Behavioral: standard treatment

Behavioral: virtual reality treatment

standard treatment group

Active Comparator group

Description:

18 sessions of standard treatment plus balance training.

Treatment:

Behavioral: balance training

Behavioral: standard treatment