StrokeHome-VRNCT02393170
Home-based -Virtual Reality Intervention for Stroke Rehabilitation
A study testing self-training using video-games and traditional self-training in people with Stroke, run by Sheba Medical Center at 1 site in Israel.
Trial summary
On-going rehabilitation is needed to maintain and improve the weaker upper extremity following stroke. Community rehabilitation programs for stroke individuals in the chronic stage are often difficult to be implement. Consequently, many individuals remain without structured interventional programs. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- self-training using video-games and traditional self-training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2014to Aug 2015
- 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
- 6 to 36 months after stroke onset
- lived in the community with family or a caregiver
- mild to moderate weakness the affected upper extremity
- without significant cognitive deficit
- able to walk at least 10-meters (with or without assistance).
Who cannot join
- Other neurological conditions
- Epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality Intervention for Stroke Rehabilitation - Home Based (Stage 2)
On-going rehabilitation is needed to maintain and improve the weaker upper extremity following stroke. Community rehabilitation programs for stroke individuals in the chronic stage are often difficult to be implement. Consequently, many individuals remain without structured interventional programs. Self-training programs, where individuals can independently continue to exercise at home, might answer this challenge. However, since exercising alone is boring and not motivating, individuals often stop the prescribed exercises and remain inactive. The use of video-games for self-training might answer this challenge.
Therefore, the investigators aimed to assess the feasibility of using video-games for self-training after stroke. Specifically the investigators aim to compare the (1) training time, (2) satisfaction and (3) effectiveness of a self-training program using video-games compared to a traditional self-training program.
Read the detailed description
This is a single-blind randomized controlled trial with four assessments; two before and two following the 5-week self training intervention.
Individuals are requested to perform the self training (video-games or traditional exercises) 60 minutes a day for 5 weeks.
- Conditions
- Stroke
- Being tested
- self-training using video-games, traditional self-training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-training using video-gamesOther
Individuals will receive a video-game console and will be taught how to play the games.
They will be requested to play 60 minutes a day for 5 weeks.
traditional self-trainingOther
Individuals will receive a manual and equipment and will be taught how to perform the exercises. They will be requested to perform the exercises 60 minutes a day for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| self-training using video-games | Experimental | Participants will receive a video-game console and will be asked to play video-games for one hour a day X 6 days a week for 5 weeks. Receives: Other: self-training using video-games |
| traditional self-training | Active comparator | Participants will receive a manual and kit of a traditional self-training program and will be asked to perform the program one hour a day X 6 days a week for 5 weeks. Receives: Other: traditional self-training |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-training time
Self-training time for the 5-week program as documented on a daily log sheet by the participants in both self-training programs. The mean weekly training hours per week will also be calculated.
Measured: week 9
Change in Action Research Arm Test
change in functional ability of the weaker upper extremity
Measured: week 0, week 4, week 9, week 13
Secondary outcomes (6)
Change in Box and Block Test
Change in dexterity of the weaker upper extremity as assessed by the Box and Block Test
Measured: week 0, week 4, week 9, week 13
Change in The Functional Reach Test
Change in standing balance
Measured: week 4, week 9, week 13
Daily enjoyment from the self-training
For each daily session participants rated their perceived enjoyment (1-5 points).
Measured: week 9
Change in the Motor Activity Log (MAL)
Change in daily use of the weaker upper extremity by using the MAL. This self-report questionnaire generates two seperate scores ranging from 0 to 5, regarding the amount and quality of the weaker upper extremity
Measured: week 0, week 4, week 9, week 13
Daily exertion from the self-training
For each daily session participants rated their perceived exertion (6-20 on the Borg scale). A mean score will be calculated per week.
Measured: week 9
Satisfaction from the self-training program
Satisfaction from the 5-week program and their perceived benefit from the program for improving their weaker upper extremity and balance on a 5-point Likert scale from "not at all" to "very much".
Measured: week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Debbie Rand, OT, PhD, Study director, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393170
- Sponsor's protocol ID
- SHEBA-14-1764-HW-CTIL
- Acronym
- Home-VR
- Status last verified
- Feb 2016
- First submitted
- 22 Feb 2015
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Intervention for Stroke Rehabilitation - Home Based (Stage 2)
- ClinicalTrials.gov ID
- NCT02393170
- Acronym / sponsor ID
- Home-VR / SHEBA-14-1764-HW-CTIL
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- European Commission
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 19 Mar 2015 (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.
On-going rehabilitation is needed to maintain and improve the weaker upper extremity following stroke. Community rehabilitation programs for stroke individuals in the chronic stage are often difficult to be implement. Consequently, many individuals remain without structured interventional programs. Self-training programs, where individuals can independently continue to exercise at home, might answer this challenge. However, since exercising alone is boring and not motivating, individuals often stop the prescribed exercises and remain inactive. The use of video-games for self-training might answer this challenge.
Therefore, the investigators aimed to assess the feasibility of using video-games for self-training after stroke. Specifically the investigators aim to compare the (1) training time, (2) satisfaction and (3) effectiveness of a self-training program using video-games compared to a traditional self-training program.
Detailed description
This is a single-blind randomized controlled trial with four assessments; two before and two following the 5-week self training intervention.
Individuals are requested to perform the self training (video-games or traditional exercises) 60 minutes a day for 5 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-training using video-games | Experimental | Other: self-training using video-gamesParticipants will receive a video-game console and will be asked to play video-games for one hour a day X 6 days a week for 5 weeks. |
| traditional self-training | Active comparator | Other: traditional self-trainingParticipants will receive a manual and kit of a traditional self-training program and will be asked to perform the program one hour a day X 6 days a week for 5 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 6 to 36 months after stroke onset
- lived in the community with family or a caregiver
- mild to moderate weakness the affected upper extremity
- without significant cognitive deficit
- able to walk at least 10-meters (with or without assistance).
Key exclusion criteria (2 listed)
- Other neurological conditions
- Epilepsy
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 |
|---|---|---|
| self-training using video-gamesIndividuals will receive a video-game console and will be taught how to play the games. They will be requested to play 60 minutes a day for 5 weeks. | Other | self-training using video-games |
| traditional self-trainingIndividuals will receive a manual and equipment and will be taught how to perform the exercises. They will be requested to perform the exercises 60 minutes a day for 5 weeks. | Other | traditional self-training |
Primary outcome
self-training time
Time frame: week 9
Self-training time for the 5-week program as documented on a daily log sheet by the participants in both self-training programs. The mean weekly training hours per week will also be calculated.
Change in Action Research Arm Test
Time frame: week 0, week 4, week 9, week 13
change in functional ability of the weaker upper extremity
6 secondary outcomes
Change in Box and Block Test
Time frame: week 0, week 4, week 9, week 13
Change in The Functional Reach Test
Time frame: week 4, week 9, week 13
Daily enjoyment from the self-training
Time frame: week 9
Change in the Motor Activity Log (MAL)
Time frame: week 0, week 4, week 9, week 13
Daily exertion from the self-training
Time frame: week 9
Satisfaction from the self-training program
Time frame: week 9
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 15 Feb 2016.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
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, OT, PhD study director
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-training using video-games and traditional self-training in people with Stroke, run by Sheba Medical Center at 1 site in Israel.
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 5 inclusion and 2 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 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
self-training time (time frame: week 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2016.