Virtual Reality Intervention for Stroke Rehabilitation

Stroke Clinical Trial

Official title:

Virtual Reality Intervention for Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304017
• Other study ID #: SHEBA-10-8401-HW-CTIL
• Status: Completed
• Phase: N/A
• First received: February 16, 2011
• Last updated: June 21, 2015
• Start date: September 2011
• Est. completion date: August 2013

Study information

• Verified date: June 2015
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	European Commission

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	Yes