Virtual Environment Rehabilitation for Chronic Stroke (VEHAB)

This study has been completed.
Sponsor:
Information provided by:
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01414686
First received: August 8, 2011
Last updated: August 10, 2011
Last verified: August 2011
  Purpose

More than half of individuals post-stroke have residual movement disabilities, including reduced mobility, balance, and increased risk of falling. There is a need for innovative, long-term and economically-feasible interventions for those with chronic stroke. Recently, a focus has been placed on the use of virtual reality and interactive gaming as a low cost and effective manner of treating movement disorders. Yet few studies have investigated interactive gaming platforms effect on balance following stroke. The proposed study is a randomized, single-blind, control group cross-over study for individuals with chronic stroke designed to examine an innovative therapeutic approach by investigating the effects of commercially-available gaming systems on balance, mobility and fear of falling in a sample of individuals with chronic motor deficits following stroke.


Condition Intervention Phase
Stroke
Other: Commercially-Available Interactive Video Games
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Commercially-Available Interactive Video Games for Individuals With Chronic Mobility and Balance Deficits Post-Stroke

Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Balance (Berg Balance Scale) [ Time Frame: change from pre to post and change from pre to follow-up (3 months) ] [ Designated as safety issue: Yes ]
    Do determine the influence of active gaming on balance in individuals with chronic stroke


Secondary Outcome Measures:
  • balance (Berg Balance Scale) [ Time Frame: change from pre to post and change from pre to follow-up (3 months) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: May 2008
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Other Names:
  • Gaming
  • Nintendo Wii
  • Playstation
  • Stroke
No Intervention: Delayed Treatment Group

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than 6 months following stroke
  • Ability to walk 10 feet with or without assistance
  • 18 years of age or older
  • Clinical presentation of unilateral hemiplegia post-stroke
  • Ability to follow simple two-step instructions

Exclusion Criteria:

  • Unable to ambulate 150 feet prior to stroke
  • History of serious chronic obstructive pulmonary disease or oxygen dependence
  • Severe weight bearing pain
  • Lower-extremity amputation
  • Non-healing ulcers on the lower extremity
  • Renal dialysis or end stage liver disease
  • Legal blindness or deafness or severe visual or hearing impairment
  • A history of significant psychiatric illness defined by diagnosis of bipolar affective disorder, psychosis, or schizophrenia
  • Life expectancy less than one year
  • Severe arthritis or orthopaedic problems that limit passive ranges of motion of lower extremity: Knee flexion contracture of -10 degrees, Knee flexion ROM < 90 degrees, hip flexion contracture > 25 degrees, ankle plantar flexion contracture > 15 degrees
  • History of deep venous thrombosis or pulmonary embolism within 6 months
  • Uncontrollable diabetes: diabetic coma, frequent insulin reactions
  • Severe hypertension with systolic > 200mmHg and diastolic > 110mmHg at rest
  • Intracranial hemorrhage related to aneurysm rupture or an arteriovenous malformation (hemorrhagic infarctions will not be excluded)
  • History of severe seizure disorder; other neurological conditions such as multiple sclerosis or Parkinson's Disease
  • Pain that is scored greater than 5 out of 10 on a visual analog scale and limits daily activity
  • Any health problems judged by their screening physician to put the client at significant risk of harm during the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414686

Locations
United States, South Carolina
University of South Carolina - Public Health Research Building
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
Investigators
Principal Investigator: Stacy L Fritz, PhD University of South Carolina
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Stacy Fritz, University of South Carolina
ClinicalTrials.gov Identifier: NCT01414686     History of Changes
Other Study ID Numbers: Robert Wood Johnson Foundation
Study First Received: August 8, 2011
Last Updated: August 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 30, 2014