Clinical trial NCT01414686: Virtual Environment Rehabilitation for Chronic Stroke
Official title: Commercially-Available Interactive Video Games for Individuals With Chronic Mobility and Balance Deficits Post-Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility 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

Primary outcomes:
measure: Balance (Berg Balance Scale)
timeFrame: change from pre to post and change from pre to follow-up (3 months)
Secondary outcomes:
measure: balance (Berg Balance Scale)
timeFrame: change from pre to post and change from pre to follow-up (3 months)
measure: balance (Berg Balance Scale)
timeFrame: post (5 weeks)
measure: Participant Perception
timeFrame: Post test (5 weeks)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina - Public Health Research Building
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Stacy L Fritz, PhD
role: PRINCIPAL_INVESTIGATOR
References: