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

NCT06864741 | Recruiting

• 1 other identifier: 70851
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

stroke; rehabilitation; motor disorder; virtual reality

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Treatment effectiveness - Motor performance

  From enrollment to one week following the end of treatment

• Treatment effectiveness - Quality of life

  From enrollment to one week following the end of treatment

• VR motor assessment validity

  From enrollment to one week following the end of treatment

• Gender differences in acceptance of VR rehabilitation technology

  From enrollment to one week following the end of treatment

• Independent use of home-based VR treatment

  From enrollment through standard of care and VR treatment completion on Day 47

Study Arms (4)

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

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

Behavioral: Virtual reality guided motor rehabilitation

Interventions

Virtual reality guided motor rehabilitation BEHAVIORAL

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

At Home - Virtual Reality Rehabilitation; In Hospital - Virtual Reality Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Acadia University: collaborator

Study Sites (1)

Valley Regional Hospital

Kentville, Nova Scotia, B4N 5E3, Canada

RECRUITING

MeSH Terms

Conditions

Stroke; Motor Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 7, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

CA (1)