Virtual Environment Rehabilitation for Chronic Stroke (VEHAB)
|ClinicalTrials.gov Identifier: NCT01414686|
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : August 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Commercially-Available Interactive Video Games||Phase 2|
Objective: To determine if playing active video games results in improved balance and motor performance.
Design: Randomized-matched, single-blind, control group cross-over study Setting: Laboratory Patients: Participants with chronic hemiparesis post-stroke were randomly assigned to a gaming group or normal activity control group.
Interventions: Gaming systems provided an interactive interface of real-time movement of either themselves or an avatar on the screen. Participants played games 1 hour/day, 4 days/week, for 5 weeks, totaling 20 hours of game-play. The intervention was strictly game-play without physical therapy. All games were played in standing position and trainers supervised to protect against loss of balance.
Measurements: Both groups were tested prior to and following the 5 weeks (post-test) and 3 months following the completion of the intervention/control. Outcome measures included: Fugl-Meyer Motor Exam, Single Leg Stance time, symmetrical weight bearing, Berg Balance Scale, Dynamic Gait Index, Timed Up and Go, Six Minute Walk, 3 Meter Walk, step length differential, and perception of recovery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Commercially-Available Interactive Video Games for Individuals With Chronic Mobility and Balance Deficits Post-Stroke|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||June 2011|
|Experimental: Immediate Treatment Group||
Other: Commercially-Available Interactive Video Games
Two commercially available gaming platforms were used in this study, the Nintendo Wii and the Sony PS 2. The Wii games included "Wii Sports" and "Wii Fit"; PS games included the EyeToy "Play 2" and "Kinetic". Each of these games provides multiple mini games which pose different movement challenges, including dynamic balance, speed, accuracy, general mobility, and weight shifts.
Game play was performed 1 hour/day, 4 days/ week, for a period of 5 weeks, totaling 20 hours.
|No Intervention: Delayed Treatment Group|
- Balance (Berg Balance Scale) [ Time Frame: change from pre to post and change from pre to follow-up (3 months) ]Do determine the influence of active gaming on balance in individuals with chronic stroke
- balance (Berg Balance Scale) [ Time Frame: change from pre to post and change from pre to follow-up (3 months) ]Determine whether the Nintendo Wii games or the Sony PlayStation 2 EyeToy a) offers superior improvement of balance
- balance (Berg Balance Scale) [ Time Frame: post (5 weeks) ]Determine whether individuals with low or high fall risk show greater improvements in balance following participation in an interactive video game session.
- Participant Perception [ Time Frame: Post test (5 weeks) ]Determine whether the Nintendo Wii games or the Sony PlayStation 2 EyeToy offers superior participant perception of 1) enjoyability of the game, 2) feasibility for independent use of the game, and 3) improvement in perceived mobility as a result of the game.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414686
|United States, South Carolina|
|University of South Carolina - Public Health Research Building|
|Columbia, South Carolina, United States, 29208|
|Principal Investigator:||Stacy L Fritz, PhD||University of South Carolina|