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Completed

NCT Number: NCT01414686

Virtual Environment Rehabilitation for Chronic Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of South Carolina - Public Health Research Building

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Commercially-Available Interactive Video Games

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

Commercially-Available Interactive Video Games for Individuals With Chronic Mobility and Balance Deficits Post-Stroke

Acronym: VEHAB

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 11, 2011
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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