Virtual Reality Intervention for Stroke Rehabilitation

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).

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Virtual Reality; Other: Traditional Therapy

Detailed Description

In Israel there are approximately 16,000 new cases of stroke per year and recently stroke has been recognized by the Israeli health-care policy planners as a top priority disease. Individuals who have sustained a stroke constitute a large population with significant needs for rehabilitation. The most common symptom following stroke is paresis or paralysis to half of the body, contralateral to the side of brain lesion. These individuals experience difficulties performing basic activities of daily life (BADL) such as dressing and walking, in addition to instrumental activities of daily life (IADL) such as shopping and cooking.

Physical activity has been strongly recommended for these individuals to maintain their functional level which was achieved during rehabilitation. In addition regular physical activity can prevent secondary conditions such as heart disease, diabetes, obesity and decreases the risk of a recurrent stroke. Reduced physical activity can also lead to disuse atrophy and cardiovascular de-conditioning, which can result in deterioration of the person's physical 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 has been recognized to be a main factor in facilitating recovery post stroke and an important factor in preventing a recurrent stroke and due to the fact that individuals with stroke are not participating sufficiently in physical activity. Their physical and functional ability may deteriorate leading to expensive hospitalization and devastating outcomes, therefore, I suggest to carry out this study.

STUDY OBJECTIVES:

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.

METHODS:

A Randomized Controlled Trial (RCT) comparing VR therapy to traditional therapy will be applied. Eligible participants will be randomly allocated to the experimental or the control group. Blind assessors will assess their ability pre and post a 3-month intervention and at 3-month follow-up. Novel instrumentation of VR systems and video-game consoles will be applied for the intervention of the experimental group and accelerometers (that measure the intensity and duration of movement) will be utilized for assessing 'free-living' daily physical activity of the upper and lower extremities of both groups. In addition clinical assessments will be administered to assess the motor and functional ability of these individuals.

The main hypotheses are:

1. Daily walking post intervention will increase significantly more in the VR therapy groups compared to the traditional therapy groups.
2. Daily use of the weak upper extremity post intervention will increase significantly more in the VR therapy groups compared to the traditional therapy groups.
3. Daily walking on follow-up will be significantly higher in the VR therapy groups compared to the traditional therapy groups.
4. Daily use of the weak upper extremity on follow-up will increase significantly more in the VR therapy groups compared to the traditional therapy groups.

Secondary hypotheses;

1. Post intervention and on follow-up, the motor and functional ability of the weak upper extremity of the individuals in the VR therapy group will improve significantly more compared to the motor and functional ability of the weak upper extremity of individuals in the traditional therapy group.
2. Post intervention and on follow-up, the motor and functional ability of the weak lower extremity and balance of the individuals in the VR therapy group will improve significantly more compared to the individuals in the traditional therapy group.
3. Participation in ADL post intervention and on follow-up will be significantly higher in the VR therapy groups compared to the traditional therapy groups.
4. The executive functions of the individuals post intervention and on follow-up will be significantly higher in the VR therapy group compared to the traditional therapy group.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: '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 Names: 'Community based' Traditional therapy program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Fugl-Meyer Motor Assessment (FMA) (upper extremity subtest)	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.	6 months
The Action Research Arm Test (ARAT)	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.	6 months
The Box and Blocks test	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.	6 months
The 10-meter walk test (10MWT)	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.	6 months
Timed get up & Go Test	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.	6 months
The Executive Functions Route Finding Test (EFRT)	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.	6 months
Walking while Talking (WWT)	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.	6 months

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: European Commission
• Investigators: Study Director: Debbie Rand, PhD, Tel Aviv University; Principal Investigator: Harold Weingarden, MD, Sheba Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: February 16, 2011
• First Submitted That Met QC Criteria: February 24, 2011
• First Posted (Estimate): February 25, 2011

Study Record Updates

• Last Update Posted (Estimate): June 23, 2015
• Last Update Submitted That Met QC Criteria: June 21, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: physical activity; stroke; rehabilitation; intervention; participation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: SHEBA-10-8401-HW-CTIL