Virtual Environment Rehabilitation for Chronic Stroke (VEHAB)

April 17, 2019 updated by: Stacy Fritz, University of South Carolina

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina - Public Health Research Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • Stroke
  • Nintendo Wii
  • Gaming
  • Playstation
NO_INTERVENTION: Delayed Treatment Group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
change from pre to post and change from pre to follow-up (3 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
change from pre to post and change from pre to follow-up (3 months)
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.
post (5 weeks)
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.
Post test (5 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stacy L Fritz, PhD, University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00001904

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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