Virtual Reality Rehabilitation for Stroke Patients in the Hospital and at Home.

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:

• 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 Overview

• Status: Recruiting
• Conditions: Stroke Acute
• Intervention / Treatment: Behavioral: Virtual reality guided motor rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Kentville, Nova Scotia, Canada, B4N 5E3
      • Recruiting
      • Valley Regional Hospital
      • Contact: Daniel H Affiliated Scientist (Research), PhD; Phone Number: 902-585-1220; Email: daniel.blustein@acadiau.ca
      • Principal Investigator: Daniel H Blustein, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: In Hospital - Standard of Care; Inpatient standard of care for acute stroke
Experimental: In Hospital - Virtual Reality Rehabilitation; Inpatient supplementary rehabilitation delivered through a virtual reality headset	Behavioral: Virtual reality guided motor rehabilitation; Custom rehabilitation exercises running on a Meta Quest 2/3S/3 head mounted virtual reality display.
No Intervention: At Home - Standard of care; Outpatient standard of care for acute stroke
Experimental: At Home - Virtual Reality Rehabilitation; Outpatient supplementary rehabilitation delivered through a virtual reality headset	Behavioral: Virtual reality guided motor rehabilitation; Custom rehabilitation exercises running on a Meta Quest 2/3S/3 head mounted virtual reality display.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	From enrollment through standard of care and VR treatment completion on Day 47

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	From enrollment to one week following the last VR session

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Collaborators: Acadia University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: stroke; rehabilitation; virtual reality; motor disorder
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Motor Disorders; Stroke
• Other Study ID Numbers: 70851

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No