An interventional study of Virtual Reality and Traditional Therapy in Stroke, sponsored by Sheba Medical Center. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-06-23.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment
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).
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:
Secondary hypotheses;
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 47 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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 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
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
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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
No study locations are listed for this record.
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sheba Medical Center