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Recruiting NCT06864741

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

No phase Interventional Stroke Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual reality guided motor rehabilitation.
Who it may be relevant to
Registry conditions: Stroke Acute. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Acute Stroke Rehabilitation Using a Low-cost Virtual Reality Platform: a Pilot Study.

Overview

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.

Interventions

  • Behavioral Virtual reality guided motor rehabilitation
    Custom rehabilitation exercises running on a Meta Quest 2/3S/3 head mounted virtual reality display.

Primary outcome measures

  • Treatment effectiveness in hospital [Time frame: From enrollment to one week following the end of treatment at day 26]
  • Treatment effectiveness at home [Time frame: From enrollment through standard of care and VR treatment completion on Day 47]
  • Treatment feasibility - Motion Sickness [Time frame: From enrollment to one week following the end of treatment]
  • Treatment feasibility - Attitudes towards technology [Time frame: From enrollment to one week following the end of treatment]
  • Patient engagement at home [Time frame: From enrollment through standard of care and VR treatment completion on Day 47]
Secondary outcome measures (7)
  • Treatment effectiveness - Motor performance [Time frame: From enrollment to one week following the end of treatment]
  • Treatment effectiveness - Quality of life [Time frame: From enrollment to one week following the end of treatment]
  • VR motor assessment validity [Time frame: From enrollment to one week following the end of treatment]
  • Gender differences in acceptance of VR rehabilitation technology [Time frame: From enrollment to one week following the end of treatment]
  • Independent use of home-based VR treatment [Time frame: From enrollment through standard of care and VR treatment completion on Day 47]
  • Performance characteristics of stroke patients [Time frame: From enrollment to last VR rehabilitation session]
  • Barriers to treatment adoption [Time frame: From enrollment to one week following the last VR session]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Valley Regional Hospital — Kentville

Identifiers

NCT: NCT06864741 · 70851

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗