Clinical trial NCT06864741: Virtual Reality Rehabilitation for Stroke Patients in the Hospital and at Home.
Official title: Acute Stroke Rehabilitation Using a Low-cost Virtual Reality Platform: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke Acute
Keywords: stroke
rehabilitation
motor disorder
virtual reality
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Acadia University
First posted: 2025-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Treatment effectiveness in hospital
timeFrame: From enrollment to one week following the end of treatment at day 26
measure: Treatment effectiveness at home
timeFrame: From enrollment through standard of care and VR treatment completion on Day 47
measure: Treatment feasibility - Motion Sickness
timeFrame: From enrollment to one week following the end of treatment
measure: Treatment feasibility - Attitudes towards technology
timeFrame: From enrollment to one week following the end of treatment
measure: Patient engagement at home
timeFrame: From enrollment through standard of care and VR treatment completion on Day 47
Secondary outcomes:
measure: Treatment effectiveness - Motor performance
timeFrame: From enrollment to one week following the end of treatment
measure: Treatment effectiveness - Quality of life
timeFrame: From enrollment to one week following the end of treatment
measure: VR motor assessment validity
timeFrame: From enrollment to one week following the end of treatment
measure: Gender differences in acceptance of VR rehabilitation technology
timeFrame: From enrollment to one week following the end of treatment
measure: Independent use of home-based VR treatment
timeFrame: From enrollment through standard of care and VR treatment completion on Day 47
measure: Performance characteristics of stroke patients
timeFrame: From enrollment to last VR rehabilitation session
measure: Barriers to treatment adoption
timeFrame: From enrollment to one week following the last VR session
Other outcomes:
Locations:
city: Kentville
country: Canada
facility: Valley Regional Hospital
state: Nova Scotia
Study officials:
References: