Effect of Upper Extremity Rehabilitation Using Fully-immersive Virtual Reality for Motor Recovery in Chronic Stroke Patients: A Prospective, Multicenter, Single-blind, Explorative, Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Action Research Arm Test
研究概览
简要总结
The study aimed to investigate the effect of exergames using virtual reality with head mounted device on motor recovery of upper extremities in chronic stroke patients.
详细描述
This is a crossover study for comparing conventional occupational therapy and exercise with game format using virtual reality (virtual reality exergame). The virtual reality exergame is designed to maximize the movement of upper extremities, primary to the shoulder and elbow. Fifteen chronic stroke patient will receive conventional occupational treatment and virtual reality exergame in random order with a two-week-washout period. Outcome measures will be evaluated within two days before and after each treatment, conventional treatment and virtual reality exergame.
*Due to recruitment challenges, the anticipated enrollment has been revised from 36 to 15.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic stroke patients who have passed 6 months or more without additional stroke after the first stroke
- •Patients with upper extremity dysfunction due to stroke (ischemic, hemorrhagic)
- •Patients who can move the upper extremity against gravity with a manual muscle test of grade 3 or higher in the affected shoulder and elbow, respectively
- •Patients who can stably maintain a sitting position
- •Patients who voluntarily agreed to participate in the study
排除标准
- •Patients with moderate or severe cognitive impairment with a score of 18 or less on the Mini-Mental Status Examination (K-MMSE)
- •Patients with other causes of upper extremity dysfunction, such as peripheral nerve damage, joint disease, etc.
- •Patients with a history of severe vertigo or epilepsy
- •Patients with medical reasons such as medical conditions that make it difficult to participate in research
- •Patients who may be pregnant or who are pregnant or lactating
研究组 & 干预措施
Conventional therapy first
Group receiving conventional occupational therapy first and then virtual reality exergames.
干预措施: Virtual reality exergames (Device)
Conventional therapy first
Group receiving conventional occupational therapy first and then virtual reality exergames.
干预措施: Conventional occupational therapy (Behavioral)
Virtual reality first
Group receiving virtual reality exergames with virtual reality first and then conventional occupational therapy.
干预措施: Virtual reality exergames (Device)
Virtual reality first
Group receiving virtual reality exergames with virtual reality first and then conventional occupational therapy.
干预措施: Conventional occupational therapy (Behavioral)
结局指标
主要结局
Action Research Arm Test
时间窗: Within 2 days after the end of each intervention
As an upper extremity function evaluation tool, it tests grasp, grip, pinch, and gross arm movement function as sub-tests.
次要结局
- Box and Block test(Within 2 days after the end of each intervention)
- Fugl-Meyer (FM) Assessment(Within 2 days after the end of each intervention)
- Modified Barthel Index(Within 2 days after the end of each intervention)
- Grip strength(Within 2 days after the end of each intervention)
- Beck Depression Inventory (BDI)(Within 2 days after the end of each intervention)
- Simulator Sickness Questionnaire(Day 1 and Day 12 of virtual reality exergames intervention)
研究者
Han Gil Seo
Associate Professor
Seoul National University Hospital