Acute Stroke Rehabilitation Using a Low-cost Virtual Reality Platform: a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Treatment effectiveness in hospital
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
In Hospital - Standard of Care
Inpatient standard of care for acute stroke
In Hospital - Virtual Reality Rehabilitation
Inpatient supplementary rehabilitation delivered through a virtual reality headset
干预措施: Virtual reality guided motor rehabilitation (Behavioral)
At Home - Standard of care
Outpatient standard of care for acute stroke
At Home - Virtual Reality Rehabilitation
Outpatient supplementary rehabilitation delivered through a virtual reality headset
干预措施: Virtual reality guided motor rehabilitation (Behavioral)
结局指标
主要结局
Treatment effectiveness in hospital
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Performance characteristics of stroke patients(From enrollment to last VR rehabilitation session)
- Treatment effectiveness - Motor performance(From enrollment to one week following the end of treatment)
- Treatment effectiveness - Quality of life(From enrollment to one week following the end of treatment)
- VR motor assessment validity(From enrollment to one week following the end of treatment)
- Gender differences in acceptance of VR rehabilitation technology(From enrollment to one week following the end of treatment)
- Independent use of home-based VR treatment(From enrollment through standard of care and VR treatment completion on Day 47)
- Barriers to treatment adoption(From enrollment to one week following the last VR session)