Virtual Reality Intervention for Stroke Rehabilitation

NCT01304017 | Completed

• 1 other identifier: SHEBA-10-8401-HW-CTIL
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

In Israel approximately 16,000 people have a stroke each year. Most of these people suffer from weakness or paralysis of half of their body which leads to difficulties performing basic activities of daily life (BADL) such as dressing and walking. Due to the stroke, these individuals need to undergo intensive rehabilitation. After rehabilitation, physical activity has been strongly recommended to maintain their functional level which was achieved during rehabilitation. In addition regular physical activity can prevent secondary condition However, recent findings suggest that people with stroke do not perform enough physical activity with their upper and lower extremities. The use of Virtual Reality (VR) for rehabilitation has been found to have potential for encouraging active purposeful movement. Many researchers have assessed the feasibility \& usability of different VR systems and environments for individuals with stroke. Costly VR systems in addition to off-the-shelf video game consoles (e.g. Sony PlayStation EyeToy, Nintendo Wii) have been found to have great potential to encourage active purposeful movement. However, to date, only a limited number of studies have investigated the effectiveness of VR therapy post-stroke. Since physical activity is important after stroke and the fact that individuals with stroke are not participating sufficiently in physical activity, I suggest to carry out this study. The overall aim of this study is to assess the effectiveness of using novel technology of VR therapy to promote the participation in daily physical activity of individuals with stroke. A 'Community based' VR program will be compared to a traditional therapy program in promoting daily physical activity of the lower and upper extremities. It is hypothesized that the VR intervention will be more efficient than the traditional therapy in promoting physical activity (walking and use of the weak upper extremity).

Conditions

Stroke

Keywords

rehabilitation; stroke; intervention; physical activity; participation

Outcome Measures

Primary Outcomes (1)

• Physical activity of the lower and upper extremities

  Physical activity of the lower and upper extremities will be measured using accelerometers to quantify the amount of hand usage, the number of steps taken per day and energy expenditure.

  6 months

Secondary Outcomes (7)

• The Fugl-Meyer Motor Assessment (FMA) (upper extremity subtest)

  6 months

• The Action Research Arm Test (ARAT)

  6 months

• The Box and Blocks test

  6 months

• The 10-meter walk test (10MWT)

  6 months

• Timed get up & Go Test

  6 months

Study Arms (2)

Virtual Reality Therapy

EXPERIMENTAL

The VR-therapy will include the playing of various virtual reality or video-games which encourages the use of the extremities while sitting and standing.

Other: Virtual Reality

Traditional Therapy

ACTIVE COMPARATOR

The traditional therapy will include exercises for balance and walking and for the upper extremity using traditional therapeutic tools such as balls, weights, chairs, bands, steps, etc.

Other: Traditional Therapy

Interventions

Virtual Reality OTHER

The VR-therapy will include the playing of various virtual reality or video-games which encourages the use of the extremities while sitting and standing

Also known as: 'Community based' VR program

Virtual Reality Therapy

Traditional Therapy OTHER

The traditional therapy will include exercise for balance and walking and for the upper extremity using traditional therapeutic tools such as balls, weights, chairs, bands, steps, etc.

Also known as: 'Community based' Traditional therapy program

Traditional Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who have sustained a stroke at least 6 months prior to the study.
• Are living in the community.
• Are not receiving rehabilitation treatments.
• Are experiencing difficulty using their legs and/or arms
• Are able to walk 10 meters (with or without assistance)
• Able to understand and follow simple instructions and to sign the informed consent form (assessed using MMSE score \< 20/30 points).
• Are willing to commit to attend two treatment sessions per week for 3 months.

You may not qualify if:

• Have suffered in the past from epilepsy seizures
• Have a neurological or orthopedic condition other than stroke that prevented independence in walking and BADL prior the stroke.
• Have uncontrolled high blood pressure or unstable cardio-vascular condition (according to a letter from the family doctor).
• Have vision deficits that cannot be corrected with glasses

Sponsors & Collaborators

• Sheba Medical Center: lead
• European Commission: collaborator

Related Publications (1)

• Givon N, Zeilig G, Weingarden H, Rand D. Video-games used in a group setting is feasible and effective to improve indicators of physical activity in individuals with chronic stroke: a randomized controlled trial. Clin Rehabil. 2016 Apr;30(4):383-92. doi: 10.1177/0269215515584382. Epub 2015 May 7.

  PMID: 25952586 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Debbie Rand, PhD

  Tel Aviv University

  STUDY DIRECTOR

• Harold Weingarden, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Day Rehabilitation Unit

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 25, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 23, 2015

Record last verified: 2015-06