StrokeNCT01304017
Virtual Reality Intervention for Stroke Rehabilitation
A study testing Virtual Reality and Traditional Therapy in people with Stroke, run by Sheba Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual Reality and Traditional Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
Read more
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).
Read the 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:
- Daily walking post intervention will increase significantly more in the VR therapy groups compared to the traditional therapy groups.
- Daily use of the weak upper extremity post intervention will increase significantly more in the VR therapy groups compared to the traditional therapy groups.
- Daily walking on follow-up will be significantly higher in the VR therapy groups compared to the traditional therapy groups.
- 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;
- 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.
- 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.
- Participation in ADL post intervention and on follow-up will be significantly higher in the VR therapy groups compared to the traditional therapy groups.
- 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.
- Conditions
- Stroke
- Being tested
- Virtual Reality, Traditional Therapy
- Keywords
- rehabilitation, stroke, intervention, physical activity, participation
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Also called 'Community based' VR program
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 TherapyOther
Also called 'Community based' Traditional therapy 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startSep 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Dr. Harold Weingarden MD, Sheba Medical Center
- Investigators
- Debbie Rand, PhD, Study director, Tel Aviv UniversityHarold Weingarden, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304017
- Sponsor's protocol ID
- SHEBA-10-8401-HW-CTIL
- Status last verified
- Jun 2015
- First submitted
- 16 Feb 2011
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 25952586
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Intervention for Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT01304017
- Acronym / sponsor ID
- SHEBA-10-8401-HW-CTIL
- Conditions
- Stroke
- Keywords
- rehabilitation, stroke, intervention, physical activity, participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- European Commission
- Study start
- Sep 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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:
- Daily walking post intervention will increase significantly more in the VR therapy groups compared to the traditional therapy groups.
- Daily use of the weak upper extremity post intervention will increase significantly more in the VR therapy groups compared to the traditional therapy groups.
- Daily walking on follow-up will be significantly higher in the VR therapy groups compared to the traditional therapy groups.
- 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;
- 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.
- 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.
- Participation in ADL post intervention and on follow-up will be significantly higher in the VR therapy groups compared to the traditional therapy groups.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Therapy | Experimental | Other: Virtual RealityThe 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 | Active comparator | Other: Traditional TherapyThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityAlso: 'Community based' VR programThe 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 Therapy |
| Traditional TherapyAlso: 'Community based' Traditional therapy programThe 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 | Traditional Therapy |
Primary outcome
Physical activity of the lower and upper extremities
Time frame: 6 months
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.
7 secondary outcomes
The Fugl-Meyer Motor Assessment (FMA) (upper extremity subtest)
Time frame: 6 months
The Action Research Arm Test (ARAT)
Time frame: 6 months
The Box and Blocks test
Time frame: 6 months
The 10-meter walk test (10MWT)
Time frame: 6 months
Timed get up & Go Test
Time frame: 6 months
The Executive Functions Route Finding Test (EFRT)
Time frame: 6 months
Walking while Talking (WWT)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Derived from this study: PubMed 25952586Givon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debbie Rand, PhD study director
Tel Aviv University
Harold Weingarden, MD principal investigator
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Traditional Therapy in people with Stroke, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity of the lower and upper extremities (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01304017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.