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Completed

NCT Number: NCT02735265

Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic stroke person (onset>6m)
  • Could understand game command
  • Could stand unsupported or stand with advice at least 15 minute
  • Brunnstrom stage of LE ≥Ⅲ

Exclusion criteria

  • Age >75 years old or <20 years old
  • Severe visual or auditory impairment
  • Modified Ashworth Scale of LE ≥ 3
  • The Montreal Cognitive Assessment<16
  • Other medication(neural, cardio-pulmonary, musculoskeletal) that influence motor command during the game

Treatment and study plan

Virtual reality

Behavioral

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.

Standard treatment

Behavioral

CG: 90 minute of standard treatment. 12 training sessions (90 minutes a time, 2 times a week)

Primary outcomes

  1. Berg Balance Scale

    Time frame: Change from Baseline at 6 weeks and 3 month follow up

    balance function

Secondary outcomes

  1. Modified barthel index

    Time frame: Change from Baseline at 6 weeks and 3 month follow up

    Activity of daily live ability

  2. Activities-specific Balance Confidence scale

    Time frame: Change from Baseline at 6 weeks and 3 month follow up

    balance confidence

  3. Stroke Impact Scale

    Time frame: Change from Baseline at 6 weeks and 3 month follow up

    quality of life

  4. Modified Physical Activity Enjoyment Scale

    Time frame: Every training session during 6 weeks (total 12 sessions (2 times weekly))

    pleasure scale

  5. Adverse event times

    Time frame: Every training session during 6 weeks (total 12 sessions (2 times weekly))

  6. Force plate

    Time frame: Change from Baseline at 6 weeks and 3 month follow up

    balance function for Weight bearing symmetry and dynamic standing balance

  7. Functional reach test

    Time frame: Change from Baseline at 6 weeks and 3 month follow up

    balance function

  8. Timed up and go-cognition

    Time frame: Change from Baseline at 6 weeks and 3 month follow up

    balance function

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Official study title

Evaluation of the Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games for Patients With Stroke

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 12, 2016
Registry last updated
Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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