StrokePhase 1WiiSTARNCT02637791
A Low Cost Virtual Reality System for Home Based Rehabilitation of the Upper Limb Following Stroke
A Phase 1 study testing Virtual glove in people with Stroke, run by University of Nottingham.
Trial summary
Stroke is the third most common cause of mortality and the leading cause of long term disability worldwide with over 900,000 people living in England who have had a stroke. 75% of survivors regain their ability to walk again, however it is estimated that between 55 and 75% fail to regain satisfactory use of their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual glove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Sep 2013
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed diagnosis of stroke, no longer receiving any other intensive rehabilitation (intermediate care, early supported discharge) still experiencing residual upper limb dysfunction.
Who cannot join
- no detectable movement in the upper limb; premorbid disability in upper limb function; severe symptomatic arm or shoulder pain; severe visual impairments; other neurological illnesses such as head injury or multiple sclerosis; unstable medical condition; psychiatric illness; epilepsy triggered by screen images; cardiac pacemaker; unable to tolerate sitting in a chair for 30 minutes or follow a two stage command or living in a care home.
About this study
Stroke is the third most common cause of mortality and the leading cause of long term disability worldwide with over 900,000 people living in England who have had a stroke. 75% of survivors regain their ability to walk again, however it is estimated that between 55 and 75% fail to regain satisfactory use of their impaired arm. This limits the person's independence, ability to care for themselves and reduces their quality of life. Research indicates that for optimal recovery, high levels of rehabilitation are required yet current provision often fails to meet the required levels of intensity and duration of therapy.
In conjunction with stroke patients, their families and therapists, the team developed a low cost system (the virtual glove) to encourage stroke survivors to practice arm exercises at home. The system tracks infrared light emitting diodes (LEDs) positioned on the fingers turning the hand into a game controller to play games that encourage the movements of reach, grasp and release that underlie activities of daily living.
Read more
Before examining its effectiveness, the purpose of the registered study is to determine how feasible a large trial would be in terms of whether sufficient participants could be recruited, whether they would use the glove and whether outcome measures could be collected.
Patients will be recruited if they are aged 18 years or over, are recovering from a stroke, no longer receive any other intensive rehabilitation but still experiencing difficulty using their arm. After baseline measures are collected they will be randomly allocated to either the intervention group or a control group. The intervention group will have the virtual glove and games at home for a period of eight weeks and be advised to use the equipment for 20 minutes, three times a day. The control group will continue to have whatever care they are already receiving but no new interventions.
Outcome measures will be collected at baseline, four weeks and after the equipment has been removed from their home. Outcome measures will include tests of arm function as well participant reports of how often they are using their affected arm and how easy they find activities of daily living. The therapists collecting the outcome measures will not know to which group the participants have been allocated.
Once all outcome measures are collected the two groups will be compared on how much their final outcome measures differ from those collected at baseline.
- Conditions
- Stroke
- Being tested
- Virtual glove
- Keywords
- Stroke, Rehabilitation, Virtual Reality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual gloveDevice
The intervention (the virtual glove) consists of a hand-mounted power unit, with four infra- red light emitting diodes (LEDs) mounted on the user's finger tips. The LEDs are tracked using one or two Nintendo Wii motes mounted by the computer screen on which the games are displayed to translate the location of the user's hand, fingers and thumb in 3D space. Three games have been produced especially for the project with the help of therapists and stroke patients. In order to play them, users have to perform the movements of reach to grasp, grasp and release, pronation and supination that are necessary to effect many activities of daily living.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The virtual glove in their homes for a period of 8 weeks and advised to try to build up to using the system for a maximum of 20 minutes 3 times a day for 8 weeks. Receives: Device: Virtual glove |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test change from baseline at 4 weeks and 8 weeks
Change from baseline to 4 weeks and from baseline to 8 weeks in the Wolf Motor Function Test
Measured: Baseline, 4 weeks and 8 weeks
Secondary outcomes (1)
Nine-Hole Peg Test
Measured: Baseline, 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startNov 2009
- Primary completionDec 2012
- Study completionSep 2013
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 University of NottinghamThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham Trent University
- Responsible party
- Sponsor
- Investigators
- Marion Walker, PhD, Study director, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637791
- Sponsor's protocol ID
- 10057
- Acronym
- WiiSTAR
- Status last verified
- Dec 2015
- First submitted
- 15 Dec 2015
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Low Cost Virtual Reality System for Home Based Rehabilitation of the Upper Limb Following Stroke
- ClinicalTrials.gov ID
- NCT02637791
- Acronym / sponsor ID
- WiiSTAR / 10057
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, Virtual Reality
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham Trent University
- Study start
- Nov 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 22 Dec 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.
Stroke is the third most common cause of mortality and the leading cause of long term disability worldwide with over 900,000 people living in England who have had a stroke. 75% of survivors regain their ability to walk again, however it is estimated that between 55 and 75% fail to regain satisfactory use of their impaired arm. This limits the person's independence, ability to care for themselves and reduces their quality of life. Research indicates that for optimal recovery, high levels of rehabilitation are required yet current provision often fails to meet the required levels of intensity and duration of therapy.
In conjunction with stroke patients, their families and therapists, the team developed a low cost system (the virtual glove) to encourage stroke survivors to practice arm exercises at home. The system tracks infrared light emitting diodes (LEDs) positioned on the fingers turning the hand into a game controller to play games that encourage the movements of reach, grasp and release that underlie activities of daily living.
Before examining its effectiveness, the purpose of the registered study is to determine how feasible a large trial would be in terms of whether sufficient participants could be recruited, whether they would use the glove and whether outcome measures could be collected.
Patients will be recruited if they are aged 18 years or over, are recovering from a stroke, no longer receive any other intensive rehabilitation but still experiencing difficulty using their arm. After baseline measures are collected they will be randomly allocated to either the intervention group or a control group. The intervention group will have the virtual glove and games at home for a period of eight weeks and be advised to use the equipment for 20 minutes, three times a day. The control group will continue to have whatever care they are already receiving but no new interventions.
Outcome measures will be collected at baseline, four weeks and after the equipment has been removed from their home. Outcome measures will include tests of arm function as well participant reports of how often they are using their affected arm and how easy they find activities of daily living. The therapists collecting the outcome measures will not know to which group the participants have been allocated.
Once all outcome measures are collected the two groups will be compared on how much their final outcome measures differ from those collected at baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Virtual gloveThe virtual glove in their homes for a period of 8 weeks and advised to try to build up to using the system for a maximum of 20 minutes 3 times a day for 8 weeks. |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- confirmed diagnosis of stroke, no longer receiving any other intensive rehabilitation (intermediate care, early supported discharge) still experiencing residual upper limb dysfunction.
Key exclusion criteria (1 listed)
- no detectable movement in the upper limb; premorbid disability in upper limb function; severe symptomatic arm or shoulder pain; severe visual impairments; other neurological illnesses such as head injury or multiple sclerosis; unstable medical condition; psychiatric illness; epilepsy triggered by screen images; cardiac pacemaker; unable to tolerate sitting in a chair for 30 minutes or follow a two stage command or living in a care home.
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 gloveThe intervention (the virtual glove) consists of a hand-mounted power unit, with four infra- red light emitting diodes (LEDs) mounted on the user's finger tips. The LEDs are tracked using one or two Nintendo Wii motes mounted by the computer screen on which the games are displayed to translate the location of the user's hand, fingers and thumb in 3D space. Three games have been produced especially for the project with the help of therapists and stroke patients. In order to play them, users have to perform the movements of reach to grasp, grasp and release, pronation and supination that are necessary to effect many activities of daily living. | Device | Intervention |
Primary outcome
Wolf Motor Function Test change from baseline at 4 weeks and 8 weeks
Time frame: Baseline, 4 weeks and 8 weeks
Change from baseline to 4 weeks and from baseline to 8 weeks in the Wolf Motor Function Test
1 secondary outcome
Nine-Hole Peg Test
Time frame: Baseline, 4 weeks and 8 weeks
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 Dec 2015.
Related trials for Stroke
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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.
Marion Walker, PhD study director
University of Nottingham
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Virtual glove in people with Stroke, run by University of Nottingham.
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 1 inclusion and 1 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 Dec 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Wolf Motor Function Test change from baseline at 4 weeks and 8 weeks (time frame: Baseline, 4 weeks and 8 weeks). 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 23 Dec 2015.