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

NCT ID: NCT06864741

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2027-06-30

Brief 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. 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.

Conditions

Stroke Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

In Hospital - Standard of Care

Inpatient standard of care for acute stroke

Group Type: NO_INTERVENTION

No interventions assigned to this group

In Hospital - Virtual Reality Rehabilitation

Inpatient supplementary rehabilitation delivered through a virtual reality headset

Group Type: EXPERIMENTAL

Virtual reality guided motor rehabilitation

Intervention Type: BEHAVIORAL

Custom rehabilitation exercises running on a Meta Quest 2/3S/3 head mounted virtual reality display.

At Home - Standard of care

Outpatient standard of care for acute stroke

Group Type: NO_INTERVENTION

No interventions assigned to this group

At Home - Virtual Reality Rehabilitation

Outpatient supplementary rehabilitation delivered through a virtual reality headset

Group Type: EXPERIMENTAL

Virtual reality guided motor rehabilitation

Intervention Type: BEHAVIORAL

Custom rehabilitation exercises running on a Meta Quest 2/3S/3 head mounted virtual reality display.

Interventions

Virtual reality guided motor rehabilitation

Custom rehabilitation exercises running on a Meta Quest 2/3S/3 head mounted virtual reality display.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acadia University

OTHER

Sponsor Role: collaborator

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Valley Regional Hospital

Kentville, Nova Scotia, Canada

Countries

Canada

Facility Contacts

Daniel H Affiliated Scientist (Research), PhD

Role: primary

daniel.blustein@acadiau.ca

902-585-1220

Other Identifiers

70851

Identifier Type: -

Identifier Source: org_study_id