Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games

April 11, 2016 updated by: Taipei Medical University Shuang Ho Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality group
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.
Behavioral: Virtual reality
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.
Behavioral: Standard treatment
CG: 90 minute of standard treatment. 12 training sessions (90 minutes a time, 2 times a week)
Active Comparator: Standard treatment only group
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.
Behavioral: Standard treatment
CG: 90 minute of standard treatment. 12 training sessions (90 minutes a time, 2 times a week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale
Time Frame: Change from Baseline at 6 weeks and 3 month follow up
balance function
Change from Baseline at 6 weeks and 3 month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified barthel index
Time Frame: Change from Baseline at 6 weeks and 3 month follow up
Activity of daily live ability
Change from Baseline at 6 weeks and 3 month follow up
Activities-specific Balance Confidence scale
Time Frame: Change from Baseline at 6 weeks and 3 month follow up
balance confidence
Change from Baseline at 6 weeks and 3 month follow up
Stroke Impact Scale
Time Frame: Change from Baseline at 6 weeks and 3 month follow up
quality of life
Change from Baseline at 6 weeks and 3 month follow up
Modified Physical Activity Enjoyment Scale
Time Frame: Every training session during 6 weeks (total 12 sessions (2 times weekly))
pleasure scale
Every training session during 6 weeks (total 12 sessions (2 times weekly))
Adverse event times
Time Frame: Every training session during 6 weeks (total 12 sessions (2 times weekly))
Every training session during 6 weeks (total 12 sessions (2 times weekly))
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
Change from Baseline at 6 weeks and 3 month follow up
Functional reach test
Time Frame: Change from Baseline at 6 weeks and 3 month follow up
balance function
Change from Baseline at 6 weeks and 3 month follow up
Timed up and go-cognition
Time Frame: Change from Baseline at 6 weeks and 3 month follow up
balance function
Change from Baseline at 6 weeks and 3 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Investigators

  • Study Chair: Hsinchieh Lee, master, Taipei Medical University, Taiwan, R.O.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Estimate)

April 12, 2016

Last Update Submitted That Met QC Criteria

April 11, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMU-JIRB 201412023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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