Virtual Reality Intervention for Stroke Rehabilitation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
European Commission
Tel Aviv University
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01304017
First received: February 16, 2011
Last updated: February 24, 2011
Last verified: February 2011
  Purpose

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).


Condition Intervention
Stroke
Other: Virtual Reality
Other: Traditional Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Virtual Reality Intervention for Stroke Rehabilitation

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Physical activity of the lower and upper extremities [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The Fugl-Meyer Motor Assessment (FMA) (upper extremity subtest) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To assess the motor impairment of the upper extremity after stroke. Each movement is graded on a 3-point scale and the total score for the upper extremity ranges from 0-60 points.

  • The Action Research Arm Test (ARAT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To assess the functional ability of the upper extremity by grasping and moving objects of different size and weight. It has four subtests; grasp, grip, pinch and gross movement. The total score is out of 57 points.

  • The Box and Blocks test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To assess manual dexterity. The subject is required to transfer as many blocks from one side of a box, over a divider, to the other side, in one minute. The number of blocks transported from one side of a box to the other in one minute is counted.

  • The 10-meter walk test (10MWT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To assess gait speed. Subjects will be asked to walk along a 14-m walkway at their comfortable walking speed using their usual walking aids. Gait speed will be calculated from the time taken to traverse the middle 10 meters, as measured by a stop-watch. The average speed will be calculated from 3 trials.

  • Timed get up & Go Test [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    To measure mobility. It includes standing from a seating position, walking, turning, stopping, and sitting down which are all important tasks needed for a person to be independently mobile. For the test, the person is asked to stand up from a standard chair and walk a distance of 3 meters, turn around and walk back to the chair and sit down again. The time to complete this is recorded.

  • The Executive Functions Route Finding Test (EFRT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To assess Executive Functioning. It involves the finding of an unfamiliar destination (office/room), located on a different floor from their current location. The examiner follows the participant and provides specific cues when needed.

  • Walking while Talking (WWT) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    To assess the ability to divide and switch attention between 2 tasks during a 6 meter walk, turn and return. Subjects will walk while reciting consecutive letters of the alphabet aloud and while reciting alternate letters of the alphabet (i.e., a, c, e,…). The walking time and the number of mistakes will be recorded.


Estimated Enrollment: 70
Study Start Date: September 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Virtual Reality Therapy
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
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 Name: 'Community based' VR program
Active Comparator: Traditional Therapy
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
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.
Other Name: 'Community based' Traditional therapy program

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Have suffered in the past from epilepsy seizures
  2. Have a neurological or orthopedic condition other than stroke that prevented independence in walking and BADL prior the stroke.
  3. Have uncontrolled high blood pressure or unstable cardio-vascular condition (according to a letter from the family doctor).
  4. Have vision deficits that cannot be corrected with glasses
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304017

Contacts
Contact: Debbie Rand, PhD 972-3-6406551 drand@post.tau.ac.il

Sponsors and Collaborators
Sheba Medical Center
European Commission
Tel Aviv University
Investigators
Study Director: Debbie Rand, PhD Tel Aviv University
Principal Investigator: Harold Weingarden, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Harold Weingarden, The Chaim Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01304017     History of Changes
Other Study ID Numbers: SHEBA-10-8401-HW-CTIL
Study First Received: February 16, 2011
Last Updated: February 24, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
rehabilitation
stroke
intervention
physical activity
participation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 14, 2014