Virtual Environment Rehabilitation for Chronic Stroke

NCT01414686 | Completed Phase 2

• 1 other identifier: Pro00001904
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Balance (Berg Balance Scale)

  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 Outcomes (3)

• balance (Berg Balance Scale)

  change from pre to post and change from pre to follow-up (3 months)

• balance (Berg Balance Scale)

  post (5 weeks)

• Participant Perception

  Post test (5 weeks)

Study Arms (2)

Immediate Treatment Group

EXPERIMENTAL

Other: Commercially-Available Interactive Video Games

Delayed Treatment Group

NO INTERVENTION

Interventions

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.

Also known as: Gaming, Nintendo Wii, Playstation, Stroke

Immediate Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina - Public Health Research Building

Columbia, South Carolina, 29208, United States

Location

Related Links

• University of South Carolina Rehabilitation Lab Website

MeSH Terms

Conditions

Stroke

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stacy L Fritz, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 11, 2011
• Study Start: May 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 19, 2019

Record last verified: 2019-04

Locations

US (1)