Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games

NCT02735265 | Completed DMC

• 1 other identifier: TMU-JIRB 201412023
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke

Keywords

Rehabilitation; Virtual reality

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale

  balance function

  Change from Baseline at 6 weeks and 3 month follow up

Secondary Outcomes (8)

• Modified barthel index

  Change from Baseline at 6 weeks and 3 month follow up

• Activities-specific Balance Confidence scale

  Change from Baseline at 6 weeks and 3 month follow up

• Stroke Impact Scale

  Change from Baseline at 6 weeks and 3 month follow up

• Modified Physical Activity Enjoyment Scale

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

• Adverse event times

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

Study Arms (2)

Virtual reality group

EXPERIMENTAL

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; Behavioral: Standard treatment

Standard treatment only group

ACTIVE COMPARATOR

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

Interventions

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.

Virtual reality group

Standard treatment BEHAVIORAL

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

Standard treatment only group; Virtual reality group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hsinchieh Lee, master

  Taipei Medical University, Taiwan, R.O.C.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 12, 2016
• Study Start: February 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 12, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share