Stroke AcuteNCT06864741
Virtual Reality Rehabilitation for Stroke Patients in the Hospital and at Home.
A study testing Virtual reality guided motor rehabilitation in people with Stroke Acute, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The goal of this clinical trial is to test whether a low-cost virtual reality (VR) motor rehabilitation platform can improve motor recovery in people recovering from a first-time ischemic stroke both in the hospital and at home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Acute
- What is being tested?
- Virtual reality guided motor rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- clinical diagnosis of first-time ischemic stroke involving the middle cerebral artery, confirmed by CT or MRI;
- score between 6 and 40 on Fugl-Meyer Assessment's Upper Limb Extremity Subscore (FM - UE), indicating moderate to severe motor deficit;
- ability and willingness to provide consent (score of 18 or more on the Montreal Cognitive Assessment) or assent (for scores lower than 18 on MoCA with consent provided by an authorized third party with the necessary legal authority to consent on behalf of patient)
- INPATIENT ARM: less than 5 weeks since stroke onset with admission to Valley Regional Hospital in Kentville, NS, Canada
- OUTPATIENT ARM: less than 3 months since stroke onset with discharge to home setting located within 1 hour drive of Valley Regional Hospital in Kentville, NS, Canada
Who cannot join
- brainstem, cerebellar or bilateral stroke lesion
- a secondary neurological condition (e.g., Parkinson's disease)
- musculoskeletal injuries interfering with task performance
- an uncorrected visual deficit due to stroke or other etiologies
- apraxia as identified by clinical assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Valley Regional Hospital
Kentville, Nova Scotia, B4N 5E3
Daniel H Affiliated Scientist (Research), PhD, 902-585-1220, daniel.blustein@acadiau.ca
Daniel H Blustein, PhD
About this study
Official title: Acute Stroke Rehabilitation Using a Low-cost Virtual Reality Platform: a Pilot Study.
The goal of this clinical trial is to test whether a low-cost virtual reality (VR) motor rehabilitation platform can improve motor recovery in people recovering from a first-time ischemic stroke both in the hospital and at home. The study focuses on adults aged 18 and older who have experienced moderate to severe upper limb motor deficits.
The main questions it aims to answer are:
Read more
- Can VR-based motor therapy improve upper limb motor function compared to standard care?
- Is VR-based motor therapy a feasible and acceptable treatment option for stroke patients?
Researchers will compare patients receiving VR therapy to those receiving standard care to see if the VR therapy leads to greater improvements in motor recovery and more positive patient experiences.
Participants will:
- Complete standardized assessments of motor function and quality of life at multiple time points.
- Participate in VR therapy sessions (if in the treatment group), using gamified activities designed to improve upper limb movement.
- Provide feedback on their experience with the VR system, including ease of use, motion sickness, and engagement.
This study will help determine whether VR-based rehabilitation can be a practical, effective way to improve access to therapy and recovery outcomes for stroke patients, especially in rural settings with limited rehabilitation resources.
- Conditions
- Stroke Acute
- Being tested
- Virtual reality guided motor rehabilitation
- Keywords
- stroke, rehabilitation, motor disorder, virtual reality
- Medical subject headings
- Stroke, Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality guided motor rehabilitationBehavioural
Custom rehabilitation exercises running on a Meta Quest 2/3S/3 head mounted virtual reality display.
| Study group | Role | What they receive |
|---|---|---|
| In Hospital - Standard of Care | No intervention | Inpatient standard of care for acute stroke |
| In Hospital - Virtual Reality Rehabilitation | Experimental | Inpatient supplementary rehabilitation delivered through a virtual reality headset Receives: Behavioral: Virtual reality guided motor rehabilitation |
| At Home - Standard of care | No intervention | Outpatient standard of care for acute stroke |
| At Home - Virtual Reality Rehabilitation | Experimental | Outpatient supplementary rehabilitation delivered through a virtual reality headset Receives: Behavioral: Virtual reality guided motor rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment effectiveness in hospital
Measure if patients receiving supplementary VR motor therapy show improved motor recovery compared to receiving standard care in hospital using the Fugl-Meyer Assessment's Upper Limb Extremity Subscore. Values range from 0 to 66 with lower scores indicating a larger motor deficit.
Measured: From enrollment to one week following the end of treatment at day 26
Treatment effectiveness at home
Measure if patients receiving supplementary VR motor therapy show improved motor recovery compared to receiving standard care for home-based patients using the Fugl-Meyer Assessment's Upper Limb Extremity Subscore. Values range from 0 to 100 with lower scores indicating a larger motor deficit.
Measured: From enrollment through standard of care and VR treatment completion on Day 47
Treatment feasibility - Motion Sickness
Measure motion sickness levels immediately after each therapy sessions using the Virtual Reality Sickness Questionnaire. Values range from 0 to 100 with higher scores indicating more reported motion sickness.
Measured: From enrollment to one week following the end of treatment
Treatment feasibility - Attitudes towards technology
Measure attitudes towards the VR technology before and after the intervention using a VR Attitudes Survey. Values range from 0 to 6 with higher scores indicating more favorable attitudes towards the VR technology.
Measured: From enrollment to one week following the end of treatment
Patient engagement at home
Assess patient engagement with adaptive at-home rehabilitation using the percentage of daily sessions completed. Values range from 0% to 100% with higher scores indicating a higher rate of session completion.
Measured: From enrollment through standard of care and VR treatment completion on Day 47
Secondary outcomes (7)
Treatment effectiveness - Motor performance
Measure if patients receiving VR motor therapy show improved motor performance using the Box and Blocks Test. Values range from 0 to 150 with higher scores indicating improved motor performance.
Measured: From enrollment to one week following the end of treatment
Treatment effectiveness - Quality of life
Measure if patients receiving VR motor therapy show reduced disability and improved health-related quality of life using the Stroke Impact Scale. Values range from 0 to 100 with higher scores indicating reduced disability and higher quality of life.
Measured: From enrollment to one week following the end of treatment
VR motor assessment validity
Examine the validity of a VR motor assessment for monitoring stroke motor recovery trajectories in the real world. This will be explored by comparing data between the real-world and virtual Box and Blocks tests which will result in a correlation coefficient ranging from 0 to 1 with a higher value indicating a stronger alignment in metrics.
Measured: From enrollment to one week following the end of treatment
Gender differences in acceptance of VR rehabilitation technology
Analyze differences between women and men in relation to the acceptance of VR treatment, using the VR Attitudes Survey. Values range from 0 to 6 with higher scores indicating more favorable attitudes towards the VR technology.
Measured: From enrollment to one week following the end of treatment
Independent use of home-based VR treatment
By meeting certain criteria during the study, participants can qualify to complete VR sessions on their own. Measure the proportion of participants qualifying for independent operation.
Measured: From enrollment through standard of care and VR treatment completion on Day 47
Performance characteristics of stroke patients
Measure motor performance for each task over time using motor performance z-scores. Mean scores equal zero with deviations indicating distance in standard deviations from the mean (with no minimum or maximum). Higher scores indicate better motor performance.
Measured: From enrollment to last VR rehabilitation session
Barriers to treatment adoption
Qualitative feedback will be analyzed thematically to identify potential barriers and enablers of adopting VR stroke rehabilitation. This qualitative analysis does not use a quantitative scale.
Measured: From enrollment to one week following the last VR session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start15 Oct 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke AcuteStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Crossover
- Model description
- During the in-hospital phase, the study model is a parallel design. During the at-home phase, the study model is a crossover design. Participants may enroll in one or both phases of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Acadia University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864741
- Sponsor's protocol ID
- 70851
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Given the small sample size and single recruitment site, the investigators are uncertain if confidentiality can be ensured with sharing IPD. The investigators will address this with the institution's Research Ethics Board.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Stroke Rehabilitation Using a Low-cost Virtual Reality Platform: a Pilot Study.
- ClinicalTrials.gov ID
- NCT06864741
- Acronym / sponsor ID
- 70851
- Conditions
- Stroke Acute
- Keywords
- stroke, rehabilitation, motor disorder, virtual reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Acadia University
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Mar 2025 (actual)
- 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 goal of this clinical trial is to test whether a low-cost virtual reality (VR) motor rehabilitation platform can improve motor recovery in people recovering from a first-time ischemic stroke both in the hospital and at home. The study focuses on adults aged 18 and older who have experienced moderate to severe upper limb motor deficits.
The main questions it aims to answer are:
- Can VR-based motor therapy improve upper limb motor function compared to standard care?
- Is VR-based motor therapy a feasible and acceptable treatment option for stroke patients?
Researchers will compare patients receiving VR therapy to those receiving standard care to see if the VR therapy leads to greater improvements in motor recovery and more positive patient experiences.
Participants will:
- Complete standardized assessments of motor function and quality of life at multiple time points.
- Participate in VR therapy sessions (if in the treatment group), using gamified activities designed to improve upper limb movement.
- Provide feedback on their experience with the VR system, including ease of use, motion sickness, and engagement.
This study will help determine whether VR-based rehabilitation can be a practical, effective way to improve access to therapy and recovery outcomes for stroke patients, especially in rural settings with limited rehabilitation resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- During the in-hospital phase, the study model is a parallel design. During the at-home phase, the study model is a crossover design. Participants may enroll in one or both phases of the study.
| Arm | Type | Receives |
|---|---|---|
| In Hospital - Standard of Care | No intervention | –Inpatient standard of care for acute stroke |
| In Hospital - Virtual Reality Rehabilitation | Experimental | Behavioral: Virtual reality guided motor rehabilitationInpatient supplementary rehabilitation delivered through a virtual reality headset |
| At Home - Standard of care | No intervention | –Outpatient standard of care for acute stroke |
| At Home - Virtual Reality Rehabilitation | Experimental | Behavioral: Virtual reality guided motor rehabilitationOutpatient supplementary rehabilitation delivered through a virtual reality headset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- clinical diagnosis of first-time ischemic stroke involving the middle cerebral artery, confirmed by CT or MRI;
- score between 6 and 40 on Fugl-Meyer Assessment's Upper Limb Extremity Subscore (FM - UE), indicating moderate to severe motor deficit;
- ability and willingness to provide consent (score of 18 or more on the Montreal Cognitive Assessment) or assent (for scores lower than 18 on MoCA with consent provided by an authorized third party with the necessary legal authority to consent on behalf of patient)
- INPATIENT ARM: less than 5 weeks since stroke onset with admission to Valley Regional Hospital in Kentville, NS, Canada
- OUTPATIENT ARM: less than 3 months since stroke onset with discharge to home setting located within 1 hour drive of Valley Regional Hospital in Kentville, NS, Canada
Key exclusion criteria (5 listed)
- brainstem, cerebellar or bilateral stroke lesion
- a secondary neurological condition (e.g., Parkinson's disease)
- musculoskeletal injuries interfering with task performance
- an uncorrected visual deficit due to stroke or other etiologies
- apraxia as identified by clinical assessment
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 guided motor rehabilitationCustom rehabilitation exercises running on a Meta Quest 2/3S/3 head mounted virtual reality display. | Behavioural | At Home - Virtual Reality Rehabilitation, In Hospital - Virtual Reality Rehabilitation |
Primary outcome
Treatment effectiveness in hospital
Time frame: From enrollment to one week following the end of treatment at day 26
Measure if patients receiving supplementary VR motor therapy show improved motor recovery compared to receiving standard care in hospital using the Fugl-Meyer Assessment's Upper Limb Extremity Subscore. Values range from 0 to 66 with lower scores indicating a larger motor deficit.
Treatment effectiveness at home
Time frame: From enrollment through standard of care and VR treatment completion on Day 47
Measure if patients receiving supplementary VR motor therapy show improved motor recovery compared to receiving standard care for home-based patients using the Fugl-Meyer Assessment's Upper Limb Extremity Subscore. Values range from 0 to 100 with lower scores indicating a larger motor deficit.
Treatment feasibility - Motion Sickness
Time frame: From enrollment to one week following the end of treatment
Measure motion sickness levels immediately after each therapy sessions using the Virtual Reality Sickness Questionnaire. Values range from 0 to 100 with higher scores indicating more reported motion sickness.
Treatment feasibility - Attitudes towards technology
Time frame: From enrollment to one week following the end of treatment
Measure attitudes towards the VR technology before and after the intervention using a VR Attitudes Survey. Values range from 0 to 6 with higher scores indicating more favorable attitudes towards the VR technology.
Patient engagement at home
Time frame: From enrollment through standard of care and VR treatment completion on Day 47
Assess patient engagement with adaptive at-home rehabilitation using the percentage of daily sessions completed. Values range from 0% to 100% with higher scores indicating a higher rate of session completion.
7 secondary outcomes
Treatment effectiveness - Motor performance
Time frame: From enrollment to one week following the end of treatment
Treatment effectiveness - Quality of life
Time frame: From enrollment to one week following the end of treatment
VR motor assessment validity
Time frame: From enrollment to one week following the end of treatment
Gender differences in acceptance of VR rehabilitation technology
Time frame: From enrollment to one week following the end of treatment
Independent use of home-based VR treatment
Time frame: From enrollment through standard of care and VR treatment completion on Day 47
Performance characteristics of stroke patients
Time frame: From enrollment to last VR rehabilitation session
Barriers to treatment adoption
Time frame: From enrollment to one week following the last VR session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided. Given the small sample size and single recruitment site, the investigators are uncertain if confidentiality can be ensured with sharing IPD. The investigators will address this with the institution's Research Ethics Board.
Related trials for Stroke Acute
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic 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.
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 guided motor rehabilitation in people with Stroke Acute, run by Nova Scotia Health Authority 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 5 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment effectiveness in hospital (time frame: From enrollment to one week following the end of treatment at day 26). The study lists 5 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 18 Mar 2026.