StrokeNCT02285933
Virtual Reality Exercise for Stroke Rehabilitation in Inpatients Who Are Unable to Stand
A study testing virtual reality training in people with Stroke, run by Bruyère Health Research Institute. at 1 site in Canada.
Trial summary
The purpose of this study is to determine if the addition of 10 to 12 sessions of sitting balance exercises using virtual reality training will provide additional gains in balance ability and function over standard inpatient rehabilitation in stroke patients. 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 reality training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to 30 Mar 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ischemic or hemorrhagic stroke in the left or right cortical or subcortical regions
- medically stable
- cannot stand independently for >1 minute or cannot stand at all
- can sit for at least 20 minutes with or without trunk support and can sit for at least 1 minute without trunk support
- able to provide informed consent
Who cannot join
- unstable cardiovascular, respiratory, endocrine, orthopedic or neurological condition that precludes exercise of low to moderate intensity
- vestibular deficits or vertigo
- seizure activity in the previous 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Addition of Virtual Reality Training to a Standard Program of Inpatient Rehabilitation Improve Sitting Balance Ability and Function After Stroke? A Blinded Randomized Controlled Trial.
The purpose of this study is to determine if the addition of 10 to 12 sessions of sitting balance exercises using virtual reality training will provide additional gains in balance ability and function over standard inpatient rehabilitation in stroke patients.
Read the detailed description
Introduction Sitting balance may be affected by stroke, resulting in functional impairment and reduced mobility. Early return of sitting balance predicts greater return of motor function and mobility after stroke. Task-specific therapy is effective but patients must be motivated to perform the exercises repeatedly for the greatest benefit.
Virtual reality training (VRT) allows patients to do exercises while interacting with a video game interface. It is enjoyable and may encourage repetition of therapeutic exercises. Past work in our laboratory showed that standing balance exercises performed with VRT produced additional improvements in gait speed and leg function over traditional inpatient rehabilitation (1). Because of legislative change in Ontario most stroke rehabilitation inpatients today cannot stand independently. There have been no studies on the effect of VRT on sitting balance.
Purpose To assess whether additional sitting balance exercises performed via VRT can improve sitting balance and sitting function (ex. reaching) in stroke rehabilitation inpatients.
Hypothesis The addition of VRT for sitting balance will significantly improve sitting balance and function, beyond the gains realized from traditional inpatient rehabilitation.
Experimental Approach In this blinded randomized control trial funded by the Heart \& Stroke Foundation, 76 participants with stroke will be recruited from an inpatient rehabilitation unit. This number will provide enough power to detect a large effect size (0.83) with the primary outcome measure and accounting for a 20% drop-out rate. Individuals who are medically stable and who can sit for at least 20 minutes with or without trunk support but cannot stand independently for more than one minute will be eligible. These criteria will target our selection to those who need to work most on sitting balance. Participants will be randomized into experimental and control groups.
Participants in both groups will perform VRT for 30-50 minutes daily for 10-12 sessions, in addition to their rehabilitation program. VRT will be delivered with Jintronix software and motion capture technology. Exercises for the experimental group will challenge sitting balance control, reaching and shifting the base of support. Control group exercises will require limited hand and arm movements, to equalize the additional time spent in an engaging activity without working on trunk balance. Control group participants will be strapped into their chair to minimize trunk movement. A CONFORMat pressure mat will be used to monitor centre of pressure changes during the intervention.
Outcome measures will be performed pre-, post- and 1 month post-intervention, by an assessor blinded to group allocation. The primary outcome measure will be the Function in Sitting Test. Secondary outcome measures will be: Ottawa Sitting Scale, Reaching Performance Scale, Wolf Motor Function Test and quantitative measures of postural control performed in sitting. Two-way analyses of variance [factors: time (pre-, post-, 1 month post-)and group(experimental, control)] and Tukey's post-hoc analyses will be used to test the effect of VRT on the outcome measures.
Significance and Knowledge Translation If we show that the addition of sitting balance exercises via VRT to traditional rehabilitation improves sitting balance and function, VRT may be added to inpatients' rehabilitation therapy. The ultimate goal is to improve the quality of patients' lives and decrease the burden on their caregivers. Since the Jintronix system is portable, we hope to acquire funding for several units. We would then be able to assess the use of VRT by therapists for inpatients and outpatients with stroke.
(1) McEwen D et al. Stroke 2014;45:1853-1855
- Conditions
- Stroke
- Being tested
- virtual reality training, control
- Keywords
- stroke, physical therapy specialty, exercise therapy, virtual reality, man-machine systems, randomized control trial, inpatients, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality trainingOther
Each participant will engage in 10-12 sessions of 30-50 minutes each of virtual reality training (VRT) using Jintronix Rehabilitation Software and three-dimensional motion capture technology. A camera captures the movements of the participant and allows him or her to control an avatar, which interacts with the game. Exercises challenge sitting balance control, reaching and shifting the base of support; for example, controlling a ball as it rolls down a maze or reaching to put dishes away in a virtual kitchen. The difficulty of the games is monitored to maintain a challenge to sitting balance. The participant sits on a CONFORMat pressure mat which continuously monitors his or her centre of pressure to ensure that the participant is adequately challenged during the VRT.
controlOther
Each participant will engage in 10-12 sessions of 30-50 minutes each of virtual reality training (VRT) using Jintronix Rehabilitation Software and three-dimensional motion capture technology. A camera captures the movements of the participant and allows him or her to control an avatar, which interacts with the game. Control group exercises require limited hand and arm movements; for example, using an arm to move a fish along a simple pathway or using the arms to pop balloons without reaching. Control group participants are strapped into their chair to minimize trunk movement. The participant sits on a CONFORMat pressure mat which continuously monitors his or her centre during the VRT.
| Study group | Role | What they receive |
|---|---|---|
| VRT | Experimental | sitting balance exercises delivered via virtual reality training Receives: Other: virtual reality training |
| control | Active comparator | virtual reality training requiring limited arm movements and no challenge to sitting balance Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Function In Sitting Test (FIST) from baseline to after 10-12 treatment sessions
assesses static, dynamic and reactional sitting balance
Measured: baseline, immediately after 10-12 treatments
Change in the Function In Sitting Test (FIST) from baseline to 1 month after second assessment
assesses static, dynamic and reactional sitting balance
Measured: baseline,1 month after second assessment
Secondary outcomes (17)
Change in the Ottawa Sitting Scale (OSS) from baseline to after 10-12 treatment sessions
assesses static and dynamic sitting balance
Measured: baseline, immediately after 10-12 treatments
Change in the Ottawa Sitting Scale (OSS) from baseline to 1 month after second assessment
assesses static and dynamic sitting balance
Measured: baseline, 1 month after second assement
Change in Limits of stability in sitting (LoS) from baseline to after 10-12 treatment sessions
assesses dynamic sitting balance using a force plate or pressure mat
Measured: before treatment, immediately after 10-12 treatments
Change in Limits of stability in sitting (LoS) from baseline to 1 month after second assessment
assesses dynamic sitting balance using a force plate or pressure mat
Measured: baseline, 1 month after second assement
Change in Postural sway in sitting from baseline to after 10-12 treatment sessions
assesses static sitting balance using a force plate or pressure mat
Measured: baseline, immediately after 10-12 treatments
Change in Postural sway in sitting from baseline to 1 month after second assessment
assesses static sitting balance using a force plate or pressure mat
Measured: baseline, 1 month after second assement
Change in the Reaching Performance Scale (RPS) from baseline to after 10-12 treatment sessions
assesses sitting balance function during reaching
Measured: baseline, immediately after 10-12 treatments
Change in the Reaching Performance Scale (RPS) from baseline to 1 month after second assessment
assesses sitting balance function during reaching
Measured: baseline, 1 month after second assement
Change in the Wolf Motor Function Test (WMFT) from baseline to after 10-12 treatment sessions
assesses sitting balance function using global arm function
Measured: baseline, immediately after 10-12 treatments
Change in the Wolf Motor Function Test (WMFT) from baseline to 1 month after second assessment
assesses sitting balance function using global arm function
Measured: baseline, 1 month after second assement
Change in The Motivation for Physical Activity Questionnaire from baseline to after 10-12 treatment sessions
Likert scale from 0-6 to assess motivation to engage in exercise
Measured: before treatment, immediately after 10-12 treatments
Change in The Motivation for Physical Activity Questionnaire from baseline to 1 month after second assessment
Likert scale from 0-6 to assess motivation to engage in exercise
Measured: baseline, 1 month after second assement
Change in the Behavioral Regulation in Exercise Questionnaire (BREQ-2) from baseline to after 10-12 treatment sessions
assesses quality of motivation to engage in exercise
Measured: baseline, immediately after 10-12 treatments
Change in the Behavioral Regulation in Exercise Questionnaire (BREQ-2) from baseline to 1 month after second assessment
assesses quality of motivation to engage in exercise
Measured: baseline, 1 month after second assessment
Psychosocial Impact of Assistive Devices Scale (PIADS)
assesses the psychosocial impact of assistive devices or technology on "functional independence, well-being and quality of life"
Measured: immediately after 10-12 treatments
Psychosocial Impact of Assistive Devices Scale (PIADS)
assesses the psychosocial impact of assistive devices or technology on "functional independence, well-being and quality of life"
Measured: 1 month after first assement
The ability to enroll an average of five new participants a month, to obtain a consent rate of 60% of eligible patients and a rate of protocol violations resulting in noncompliance with VRT of less than 10%.
assesses the feasibility of performing a larger multicentre trial of VRT with rehabilitation inpatients
Measured: immediately after 76 participants have finished the protocol and assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startJan 2015
- Primary completion1 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruyère Health Research Institute.
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute, University of Ottawa, Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Hillel Finestone, Bruyère Health Research Institute.
- Investigators
- Hillel M Finestone, MD, Principal investigator, Bruyère Health Research Institute.Heidi Sveistrup, PhD, Study director, University of OttawaMartin Bilodeau, PhD, Study director, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285933
- Sponsor's protocol ID
- G-14-0005830
- Status last verified
- Apr 2017
- First submitted
- 3 Nov 2014
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: As this is not part of a larger, multi-centre trial, we do not plan to share our data.
Publications
McEwen D, Taillon-Hobson A, Bilodeau M, Sveistrup H, Finestone H. Virtual reality exercise improves mobility after stroke: an inpatient randomized controlled trial. Stroke. 2014 Jun;45(6):1853-5. doi: 10.1161/STROKEAHA.114.005362. Epub 2014 Apr 24.
PubMed 24763929Sheehy L, Taillon-Hobson A, Sveistrup H, Bilodeau M, Fergusson D, Levac D, Finestone H. Does the addition of virtual reality training to a standard program of inpatient rehabilitation improve sitting balance ability and function after stroke? Protocol for a single-blind randomized controlled trial. BMC Neurol. 2016 Mar 31;16:42. doi: 10.1186/s12883-016-0563-x.
PubMed 27036515Sheehy L, Taillon-Hobson A, Sveistrup H, Bilodeau M, Finestone H. Implementation of a randomized controlled trial on an inpatient stroke rehabilitation unit: Lessons learned. Contemp Clin Trials Commun. 2020 Apr 6;18:100563. doi: 10.1016/j.conctc.2020.100563. eCollection 2020 Jun.
PubMed 32617429Sheehy L, Taillon-Hobson A, Sveistrup H, Bilodeau M, Yang C, Finestone H. Sitting Balance Exercise Performed Using Virtual Reality Training on a Stroke Rehabilitation Inpatient Service: A Randomized Controlled Study. PM R. 2020 Aug;12(8):754-765. doi: 10.1002/pmrj.12331. Epub 2020 Feb 21.
PubMed 31970898
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Addition of Virtual Reality Training to a Standard Program of Inpatient Rehabilitation Improve Sitting Balance Ability and Function After Stroke? A Blinded Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02285933
- Acronym / sponsor ID
- G-14-0005830
- Conditions
- Stroke
- Keywords
- stroke, physical therapy specialty, exercise therapy, virtual reality, man-machine systems, randomized control trial, inpatients, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Bruyère Health Research Institute.University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute, University of Ottawa, Heart and Stroke Foundation of Canada
- Study start
- Jan 2015 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 7 Nov 2014 (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.
The purpose of this study is to determine if the addition of 10 to 12 sessions of sitting balance exercises using virtual reality training will provide additional gains in balance ability and function over standard inpatient rehabilitation in stroke patients.
Detailed description
Introduction Sitting balance may be affected by stroke, resulting in functional impairment and reduced mobility. Early return of sitting balance predicts greater return of motor function and mobility after stroke. Task-specific therapy is effective but patients must be motivated to perform the exercises repeatedly for the greatest benefit.
Virtual reality training (VRT) allows patients to do exercises while interacting with a video game interface. It is enjoyable and may encourage repetition of therapeutic exercises. Past work in our laboratory showed that standing balance exercises performed with VRT produced additional improvements in gait speed and leg function over traditional inpatient rehabilitation (1). Because of legislative change in Ontario most stroke rehabilitation inpatients today cannot stand independently. There have been no studies on the effect of VRT on sitting balance.
Purpose To assess whether additional sitting balance exercises performed via VRT can improve sitting balance and sitting function (ex. reaching) in stroke rehabilitation inpatients.
Hypothesis The addition of VRT for sitting balance will significantly improve sitting balance and function, beyond the gains realized from traditional inpatient rehabilitation.
Experimental Approach In this blinded randomized control trial funded by the Heart \& Stroke Foundation, 76 participants with stroke will be recruited from an inpatient rehabilitation unit. This number will provide enough power to detect a large effect size (0.83) with the primary outcome measure and accounting for a 20% drop-out rate. Individuals who are medically stable and who can sit for at least 20 minutes with or without trunk support but cannot stand independently for more than one minute will be eligible. These criteria will target our selection to those who need to work most on sitting balance. Participants will be randomized into experimental and control groups.
Participants in both groups will perform VRT for 30-50 minutes daily for 10-12 sessions, in addition to their rehabilitation program. VRT will be delivered with Jintronix software and motion capture technology. Exercises for the experimental group will challenge sitting balance control, reaching and shifting the base of support. Control group exercises will require limited hand and arm movements, to equalize the additional time spent in an engaging activity without working on trunk balance. Control group participants will be strapped into their chair to minimize trunk movement. A CONFORMat pressure mat will be used to monitor centre of pressure changes during the intervention.
Outcome measures will be performed pre-, post- and 1 month post-intervention, by an assessor blinded to group allocation. The primary outcome measure will be the Function in Sitting Test. Secondary outcome measures will be: Ottawa Sitting Scale, Reaching Performance Scale, Wolf Motor Function Test and quantitative measures of postural control performed in sitting. Two-way analyses of variance [factors: time (pre-, post-, 1 month post-)and group(experimental, control)] and Tukey's post-hoc analyses will be used to test the effect of VRT on the outcome measures.
Significance and Knowledge Translation If we show that the addition of sitting balance exercises via VRT to traditional rehabilitation improves sitting balance and function, VRT may be added to inpatients' rehabilitation therapy. The ultimate goal is to improve the quality of patients' lives and decrease the burden on their caregivers. Since the Jintronix system is portable, we hope to acquire funding for several units. We would then be able to assess the use of VRT by therapists for inpatients and outpatients with stroke.
(1) McEwen D et al. Stroke 2014;45:1853-1855
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRT | Experimental | Other: virtual reality trainingsitting balance exercises delivered via virtual reality training |
| control | Active comparator | Other: controlvirtual reality training requiring limited arm movements and no challenge to sitting balance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ischemic or hemorrhagic stroke in the left or right cortical or subcortical regions
- medically stable
- cannot stand independently for >1 minute or cannot stand at all
- can sit for at least 20 minutes with or without trunk support and can sit for at least 1 minute without trunk support
- able to provide informed consent
Key exclusion criteria (3 listed)
- unstable cardiovascular, respiratory, endocrine, orthopedic or neurological condition that precludes exercise of low to moderate intensity
- vestibular deficits or vertigo
- seizure activity in the previous 6 months
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 reality trainingEach participant will engage in 10-12 sessions of 30-50 minutes each of virtual reality training (VRT) using Jintronix Rehabilitation Software and three-dimensional motion capture technology. A camera captures the movements of the participant and allows him or her to control an avatar, which interacts with the game. Exercises challenge sitting balance control, reaching and shifting the base of support; for example, controlling a ball as it rolls down a maze or reaching to put dishes away in a virtual kitchen. The difficulty of the games is monitored to maintain a challenge to sitting balance. The participant sits on a CONFORMat pressure mat which continuously monitors his or her centre of pressure to ensure that the participant is adequately challenged during the VRT. | Other | VRT |
| controlEach participant will engage in 10-12 sessions of 30-50 minutes each of virtual reality training (VRT) using Jintronix Rehabilitation Software and three-dimensional motion capture technology. A camera captures the movements of the participant and allows him or her to control an avatar, which interacts with the game. Control group exercises require limited hand and arm movements; for example, using an arm to move a fish along a simple pathway or using the arms to pop balloons without reaching. Control group participants are strapped into their chair to minimize trunk movement. The participant sits on a CONFORMat pressure mat which continuously monitors his or her centre during the VRT. | Other | control |
Primary outcome
Change in the Function In Sitting Test (FIST) from baseline to after 10-12 treatment sessions
Time frame: baseline, immediately after 10-12 treatments
assesses static, dynamic and reactional sitting balance
Change in the Function In Sitting Test (FIST) from baseline to 1 month after second assessment
Time frame: baseline,1 month after second assessment
assesses static, dynamic and reactional sitting balance
17 secondary outcomes
Change in the Ottawa Sitting Scale (OSS) from baseline to after 10-12 treatment sessions
Time frame: baseline, immediately after 10-12 treatments
Change in the Ottawa Sitting Scale (OSS) from baseline to 1 month after second assessment
Time frame: baseline, 1 month after second assement
Change in Limits of stability in sitting (LoS) from baseline to after 10-12 treatment sessions
Time frame: before treatment, immediately after 10-12 treatments
Change in Limits of stability in sitting (LoS) from baseline to 1 month after second assessment
Time frame: baseline, 1 month after second assement
Change in Postural sway in sitting from baseline to after 10-12 treatment sessions
Time frame: baseline, immediately after 10-12 treatments
Change in Postural sway in sitting from baseline to 1 month after second assessment
Time frame: baseline, 1 month after second assement
Change in the Reaching Performance Scale (RPS) from baseline to after 10-12 treatment sessions
Time frame: baseline, immediately after 10-12 treatments
Change in the Reaching Performance Scale (RPS) from baseline to 1 month after second assessment
Time frame: baseline, 1 month after second assement
Change in the Wolf Motor Function Test (WMFT) from baseline to after 10-12 treatment sessions
Time frame: baseline, immediately after 10-12 treatments
Change in the Wolf Motor Function Test (WMFT) from baseline to 1 month after second assessment
Time frame: baseline, 1 month after second assement
Change in The Motivation for Physical Activity Questionnaire from baseline to after 10-12 treatment sessions
Time frame: before treatment, immediately after 10-12 treatments
Change in The Motivation for Physical Activity Questionnaire from baseline to 1 month after second assessment
Time frame: baseline, 1 month after second assement
Change in the Behavioral Regulation in Exercise Questionnaire (BREQ-2) from baseline to after 10-12 treatment sessions
Time frame: baseline, immediately after 10-12 treatments
Change in the Behavioral Regulation in Exercise Questionnaire (BREQ-2) from baseline to 1 month after second assessment
Time frame: baseline, 1 month after second assessment
Psychosocial Impact of Assistive Devices Scale (PIADS)
Time frame: immediately after 10-12 treatments
Psychosocial Impact of Assistive Devices Scale (PIADS)
Time frame: 1 month after first assement
The ability to enroll an average of five new participants a month, to obtain a consent rate of 60% of eligible patients and a rate of protocol violations resulting in noncompliance with VRT of less than 10%.
Time frame: immediately after 76 participants have finished the protocol and assessments
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 12 Apr 2017.
- Background: PubMed 24763929McEwen D, Taillon-Hobson A, Bilodeau M, Sveistrup H, Finestone H. Virtual reality exercise improves mobility after stroke: an inpatient randomized controlled trial. Stroke. 2014 Jun;45(6):1853-5. doi: 10.1161/STROKEAHA.114.005362. Epub 2014 Apr 24.
- Background: PubMed 27036515Sheehy L, Taillon-Hobson A, Sveistrup H, Bilodeau M, Fergusson D, Levac D, Finestone H. Does the addition of virtual reality training to a standard program of inpatient rehabilitation improve sitting balance ability and function after stroke? Protocol for a single-blind randomized controlled trial. BMC Neurol. 2016 Mar 31;16:42. doi: 10.1186/s12883-016-0563-x.
- Derived from this study: PubMed 32617429Sheehy L, Taillon-Hobson A, Sveistrup H, Bilodeau M, Finestone H. Implementation of a randomized controlled trial on an inpatient stroke rehabilitation unit: Lessons learned. Contemp Clin Trials Commun. 2020 Apr 6;18:100563. doi: 10.1016/j.conctc.2020.100563. eCollection 2020 Jun.
- Derived from this study: PubMed 31970898Sheehy L, Taillon-Hobson A, Sveistrup H, Bilodeau M, Yang C, Finestone H. Sitting Balance Exercise Performed Using Virtual Reality Training on a Stroke Rehabilitation Inpatient Service: A Randomized Controlled Study. PM R. 2020 Aug;12(8):754-765. doi: 10.1002/pmrj.12331. Epub 2020 Feb 21.
- Individual participant dataSharing planned: No. As this is not part of a larger, multi-centre trial, we do not plan to share our data.
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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.
Hillel M Finestone, MD principal investigator
Bruyère Health Research Institute.
Heidi Sveistrup, PhD study director
University of Ottawa
Martin Bilodeau, PhD study director
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality training in people with Stroke, run by Bruyère Health Research Institute. at 1 site in Canada.
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 3 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 12 Apr 2017. 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 Canada. 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?
Change in the Function In Sitting Test (FIST) from baseline to after 10-12 treatment sessions (time frame: baseline, immediately after 10-12 treatments). 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?
On the ClinicalTrials.gov record for NCT02285933, which also lists 4 linked publications.
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 12 Apr 2017.