Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games

Completed

Phase N/A Results N/A

Trial Description

Virtual reality balance training has already been used in stroke rehabilitation, and previous studies supported that could improve balance ability. Although the treatment effects were supported in studies, there are still limitations in clinical intervention and the study power is not enough.
Study will use Kinect for Xbox games for balance intervention. Investigators will recruit 60 patients with chronic stroke from Shung-ho hospital clinical rehabilitation and randomly assign participants to "standard treatment plus virtual reality group" (N=30) and "standard treatment only group" (N=30). There are total 12 sessions (2 times weekly) for both groups. Investigators will assess subjects' ability for 3 times (pre- and post-intervention, follow up in post 3 month).Investigators will also record the pleasure scale and adverse event after every training session. Hypothesis is that Kinect for Xbox intervention can significantly improve subjects' balance ability, confidence of balance, ADL, and QOL compared to the conventional rehabilitation. It may help to develop a new clinical model of virtual reality training for patients with chronic stroke.

Detailed Description

Many stroke survivors suffered postural and balance problems. Decreased mobility limits their daily life activities. Virtual reality balance training has already been used in stroke rehabilitation, and previous studies supported that could improve balance ability. The mechanism is multi-sensory feedback and repeated practices that could facilitate motor learning and brain neuroplasticity. Compared to conventional rehabilitation, VR rehabilitation could increase subjects' motivation and pleasure. Although the treatment effects were supported in studies, there are still limitations in clinical intervention and the study power is not enough.
The study will use Kinect for Xbox games for balance intervention. Kinect for Xbox doesn't need additional controller held by subjects and can detect the movement in real time to give subjects visual and auditory feedback immediately. Investigators will recruit 60 patients with chronic stroke from Shung-ho hospital clinical rehabilitation and randomly assign them to "standard treatment plus virtual reality group" (N=30) and "standard treatment only group" (N=30). There are total 12 sessions (2 times weekly) for both groups. Investigators will assess subjects' ability for 3 times (pre- and post-intervention, follow up in post 3 month). The outcome measures include Force plate, Functional reach test, Berg Balance Scale, Time up and go for balance evaluations, Modified barthel index for ADL ability, Activities-specific Balance Confidence scale for balance confidence, and Stroke Impact Scale for quality of life. Investigators will also record the pleasure scale and adverse event after every training session. Collected data will be analyzed with repeated measures 2-way analysis of variance (ANOVA), Turkey test post hoc and independent T sample test. Hypothesis is that Kinect for Xbox intervention can significantly improve subjects' balance ability, confidence of balance, ADL, and QOL compared to the conventional rehabilitation. It may help to develop a new clinical model of virtual reality training for patients with chronic stroke.

Conditions

Interventions

  • Virtual Reality Device
    Intervention Desc: 12 training sessions (90 minutes a time, 2 times a week) IG:45 minute of Kinect for Xbox games and 45 minute of standard treatment.
    ARM 1: Kind: Experimental
    Label: Virtual reality group
    Description: 45 min standard treatment plus 45 min virtual reality balance training used by Kinect for Xbox game. Game choosed based on motor learning principle. Training task such as reach or stepping in various direction, squat, stand up, upper trunk forward or lateral bench.
  • Standard treatment Other
    Intervention Desc: CG: 90 minute of standard treatment. 12 training sessions (90 minutes a time, 2 times a week)
    ARM 1: Kind: Experimental
    Label: Virtual reality group
    Description: 45 min standard treatment plus 45 min virtual reality balance training used by Kinect for Xbox game. Game choosed based on motor learning principle. Training task such as reach or stepping in various direction, squat, stand up, upper trunk forward or lateral bench.
    ARM 2: Kind: Experimental
    Label: Standard treatment only group
    Description: 90 min standard treatment. Depended on patient's ability, principle used by motor learning, sensory process, motor control, task oriented training, symmetry w't bearing.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Berg Balance Scale Change from Baseline at 6 weeks and 3 month follow up Yes
Secondary Modified barthel index Change from Baseline at 6 weeks and 3 month follow up Yes
Secondary Activities-specific Balance Confidence scale Change from Baseline at 6 weeks and 3 month follow up Yes
Secondary Stroke Impact Scale Change from Baseline at 6 weeks and 3 month follow up Yes
Secondary Modified Physical Activity Enjoyment Scale Every training session during 6 weeks (total 12 sessions (2 times weekly)) Yes
Secondary Adverse event times Every training session during 6 weeks (total 12 sessions (2 times weekly)) Yes
Secondary Force plate Change from Baseline at 6 weeks and 3 month follow up Yes
Secondary Functional reach test Change from Baseline at 6 weeks and 3 month follow up Yes
Secondary Timed up and go-cognition Change from Baseline at 6 weeks and 3 month follow up Yes

Sponsors