Virtual Reality Rehabilitation for Stroke Patients in the Hospital and at Home.
ConditionStroke Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Scotia Health Authority
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Virtual reality guided motor rehabilitation
BehavioralCustom rehabilitation exercises running on a Meta Quest 2/3S/3 head mounted virtual reality display.
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: In Hospital - Standard of CareNo intervention 0 interventions
Group B: In Hospital - Virtual Reality RehabilitationExperimental treatment 1 intervention
Group C: At Home - Standard of careNo intervention 0 interventions
Group D: At Home - Virtual Reality RehabilitationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to one week following the end of treatment at day 262
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.
Time frame
From enrollment through standard of care and VR treatment completion on Day 473
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.
Time frame
From enrollment to one week following the end of treatment4
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.
Time frame
From enrollment to one week following the end of treatmentSecondary outcomes
1
Treatment effectiveness - Motor performance
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.
Time frame
From enrollment to one week following the end of treatment2
Treatment effectiveness - Quality of life
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.
Time frame
From enrollment to one week following the end of treatment3
VR motor assessment validity
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.
Time frame
From enrollment to one week following the end of treatment4
Gender differences in acceptance of VR rehabilitation technology
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.
Time frame
From enrollment to one week following the end of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nova Scotia Health Authority
Lead sponsor
Acadia University
Collaborator
Source ClinicalTrials.gov