StrokePhase 2VEHABNCT01414686
Virtual Environment Rehabilitation for Chronic Stroke
A Phase 2 study testing Commercially-Available Interactive Video Games in people with Stroke, run by University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Commercially-Available Interactive Video Games
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina - Public Health Research Building
Columbia, South Carolina, 29208
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Commercially-Available Interactive Video Games
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercially-Available Interactive Video GamesOther
Also called Gaming, Nintendo Wii, Playstation, Stroke
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment Group | Experimental | Not described Receives: Other: Commercially-Available Interactive Video Games |
| Delayed Treatment Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance (Berg Balance Scale)
Do determine the influence of active gaming on balance in individuals with chronic stroke
Measured: change from pre to post and change from pre to follow-up (3 months)
Secondary outcomes (3)
balance (Berg Balance Scale)
Determine whether the Nintendo Wii games or the Sony PlayStation 2 EyeToy a) offers superior improvement of balance
Measured: change from pre to post and change from pre to follow-up (3 months)
balance (Berg Balance Scale)
Determine whether individuals with low or high fall risk show greater improvements in balance following participation in an interactive video game session.
Measured: post (5 weeks)
Participant Perception
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.
Measured: Post test (5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startMay 2008
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacy Fritz, University of South Carolina
- Investigators
- Stacy L Fritz, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414686
- Sponsor's protocol ID
- Pro00001904
- Acronym
- VEHAB
- Status last verified
- Apr 2019
- First submitted
- 8 Aug 2011
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Commercially-Available Interactive Video Games for Individuals With Chronic Mobility and Balance Deficits Post-Stroke
- ClinicalTrials.gov ID
- NCT01414686
- Acronym / sponsor ID
- VEHAB / Pro00001904
- Conditions
- Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment Group | Experimental | Other: Commercially-Available Interactive Video Games |
| Delayed Treatment Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercially-Available Interactive Video GamesAlso: Gaming, Nintendo Wii, Playstation, StrokeTwo 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 | Immediate Treatment Group |
Primary outcome
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
3 secondary outcomes
balance (Berg Balance Scale)
Time frame: change from pre to post and change from pre to follow-up (3 months)
balance (Berg Balance Scale)
Time frame: post (5 weeks)
Participant Perception
Time frame: Post test (5 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- University of South Carolina Rehabilitation Lab WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy L Fritz, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Commercially-Available Interactive Video Games in people with Stroke, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (Berg Balance Scale) (time frame: change from pre to post and change from pre to follow-up (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.