Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02735265
• Other study ID #: TMU-JIRB 201412023
• Status: Completed
• Phase: N/A
• First received: March 21, 2016
• Last updated: April 11, 2016
• Start date: February 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 =?

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale	balance function	Change from Baseline at 6 weeks and 3 month follow up	Yes
Secondary	Modified barthel index	Activity of daily live ability	Change from Baseline at 6 weeks and 3 month follow up	Yes
Secondary	Activities-specific Balance Confidence scale	balance confidence	Change from Baseline at 6 weeks and 3 month follow up	Yes
Secondary	Stroke Impact Scale	quality of life	Change from Baseline at 6 weeks and 3 month follow up	Yes
Secondary	Modified Physical Activity Enjoyment Scale	pleasure 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	balance function for Weight bearing symmetry and dynamic standing balance	Change from Baseline at 6 weeks and 3 month follow up	Yes
Secondary	Functional reach test	balance function	Change from Baseline at 6 weeks and 3 month follow up	Yes
Secondary	Timed up and go-cognition	balance function	Change from Baseline at 6 weeks and 3 month follow up	Yes