Feasibility of Using Immersive Virtual Functional Rehabilitation for Recovery of Upper Extremity Function in Patients With Early-stage Stroke: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- System Usability Scale [SUS]
研究概览
简要总结
Feasibility of using immersive virtual functional rehabilitation for recovery of upper extremity function in patients with early-stage stroke: a pilot study
详细描述
Background: Immersive virtual reality (IVR)-based rehabilitation provides high-intensity, engaging, task-oriented training and motor exploration for upper limb (UL) recovery post-stroke. However, its feasibility and dose-response effects remain unclear.
Objective
To evaluate the feasibility and dose-response effects of IVR-based rehabilitation for UL recovery in early stroke patients.
Methods: A pilot trial included 12 early-stage stroke patients randomized into two groups: Group A (10 IVR sessions + conventional rehabilitation [CR]) and Group B (20 IVR sessions + CR). Feasibility outcomes included adherence, usability (User Satisfaction Evaluation Questionnaire [USEQ], System Usability Scale [SUS]), system operability, and adverse effects. Motor outcomes, categorized by the International Classification of Functioning, Disability, and Health (ICF), assessed UL impairment (Fugl-Meyer Assessment, Medical Research Council scale), activity (Box and Block Test), and participation (Motor Activity Log 30). Blinded therapists conducted assessments at baseline, post-intervention, and 4-week follow-up. Dose-response was analyzed using Probability of Superiority (PS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •age > 18 years old
- •first episode of stroke (ischemic or hemorrhagic)
- •time since stroke onset between 0 to 6 months
- •upper limb motor impairment with the National Institutes of Health Stroke Scale arm motor sub-item score between 1 and 4
- •medically stable parameters for rehabilitation initiation.
排除标准
- •Delirium diagnosed using the Confusion Assessment Method
- •Montreal Cognitive Assessment Scale <18
- •Severe visual/perceptual deficits (spatial neglect affecting >70% of trials or visual acuity <20/200)
- •previous participation in virtual reality-based rehabilitation
- •inability to provide informed consent.
研究组 & 干预措施
10 session
Participants receive 10 sessions of intervention with virtual inmersive reality.
Virtual reality with hand tracking and immersive environment
干预措施: Immersive virtual reality (Device)
20 sessions
Participants receive 20 sessions of intervention with virtual inmersive reality. Virtual reality with hand tracking and immersive environment.
干预措施: Immersive virtual reality (Device)
结局指标
主要结局
System Usability Scale [SUS]
时间窗: The treatment providers fill out the questionnaire at the end of treatment. It depends of the group patient: 10 or 20-session treatment.
Questionnaire completed by the handlers who administer the immersive virtual reality system
User Satisfaction Evaluation Questionnaire [USEQ]
时间窗: Administered within the first 7 days of using the immersive virtual reality device
Questionnaire of 5 questions with 5 options based on likert rate. Is filled for the patient recruited
次要结局
- Fugl-Meyer Assessment for Upper Extremity(It is administered in three stages: Baseline or day 1 (pre treatment). In the week number 4 (post treatment). Up to 8 weeks (follow-up). Through study completion, an average of 6 months.)
- Motor Activity Log(It is administered in three stages: Baseline or day 1 (pre treatment). In the week number 4 (post treatment). Up to 8 weeks (follow-up). Through study completion, an average of 6 months.)
- Box and block test(It is administered in three stages: Baseline or day 1 (pre treatment). In the week number 4 (post treatment). Up to 8 weeks (follow-up). Through study completion, an average of 6 months.)
- Medical research council(It is administered in three stages: Baseline or day 1 (pre treatment). In the week number 4 (post treatment). Up to 8 weeks (follow-up). Through study completion, an average of 6 months.)
研究者
Margarita Venegas
Ricardo Vasquez
Clinica Alemana de Santiago