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

Not Applicable

Not yet recruiting

• Conditions: Stroke Acute

• Registration Number: NCT06864741
• Lead Sponsor: Nova Scotia Health Authority

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-03-03
• Last Update Submitted: 2025-03-03
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07
• Study Start: 2025-07
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Treatment effectiveness in hospital	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	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Performance characteristics of stroke patients	From enrollment to last VR rehabilitation session	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.
Treatment effectiveness - Motor performance	From enrollment to one week following the end of treatment	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.
Treatment effectiveness - Quality of life	From enrollment to one week following the end of treatment	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.
VR motor assessment validity	From enrollment to one week following the end of treatment	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.
Gender differences in acceptance of VR rehabilitation technology	From enrollment to one week following the end of treatment	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.
Independent use of home-based VR treatment	From enrollment through standard of care and VR treatment completion on Day 47	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.
Barriers to treatment adoption	From enrollment to one week following the last VR session	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.

Trial Locations

Locations (1)

Valley Regional Hospital; 🇨🇦 Kentville, Nova Scotia, Canada