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| Name | Class |
|---|---|
| Acadia University | OTHER |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality guided motor rehabilitation | Behavioral | Custom rehabilitation exercises running on a Meta Quest 2/3S/3 head mounted virtual reality display. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to one week following the end of treatment |
| Treatment effectiveness - Quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Regional Hospital | Recruiting | Kentville | Nova Scotia | B4N 5E3 | Canada |
Given the small sample size and single recruitment site, the investigators are uncertain if confidentiality can be ensured with sharing IPD. The investigators will address this with the institution's Research Ethics Board.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000068079 | Motor Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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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. |
| From enrollment to one week following the end of treatment |
| 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. | From enrollment to one week following the end of treatment |
| 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. | From enrollment to one week following the end of treatment |
| Independent use of home-based VR treatment | 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. | From enrollment through standard of care and VR treatment completion on Day 47 |
| Performance characteristics of stroke patients | 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. | From enrollment to last VR rehabilitation session |
| Barriers to treatment adoption | 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. | From enrollment to one week following the last VR session |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001523 | Mental Disorders |