NCT06143176尚未招募不适用
Efficacy of Virtual Reality in Upper Extremity Rehabilitation for Stroke Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Fugl-Meyer Assessment of upper extremity
研究概览
简要总结
To investigate the therapeutic effect of including virtual reality-based digital content in the upper limb motor function rehabilitation of stroke patients and to develop a treatment method to improve the upper limb motor function of stroke patients in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria for experimental group:
- •Patients aged 19 to 80 years with unilateral stroke within 6 months of stroke onset
- •Motor function evaluation: Patients showing moderate or lower upper limb dysfunction with an upper limb FMA (Fugl-Meyer Assessment) score of less than 58 points on the affected side.
- •Patients receiving or planning to receive exercise rehabilitation treatment 5 days a week
- •Inclusion Criteria for control group:
- •Patients who have been admitted to our hospital's rehabilitation medicine department and received rehabilitation treatment within the past 5 years 2) Patients with unilateral stroke within 6 months of stroke onset who are between 19 and 80 years old at the time of hospitalization 3) Patients who were admitted to the rehabilitation medicine department of our hospital and received exercise rehabilitation treatment for 4 weeks, 5 days a week 4) Patients with similar characteristics below compared to the test group
- •Age: Difference within 5 years
- •Gait function: Functional Ambulatory Category (FAC)
- •Upper extremity function: Fugl-Meyer Assessment (FMA) difference within 6 points
- •Cognitive function: Korean Version of Mini Mental State Examination (K-MMSE) difference within 5 points
- •Daily living skills: Korean Version of Modified Barthel Index (K-MBI) difference within 10 points
排除标准
- •Accompanying existing serious neurogenic disease
- •Cases accompanied by existing serious psychiatric diseases such as major schizophrenia, bipolar disorder, dementia, etc.
- •Cases where it is difficult to understand task performance due to severe cognitive decline (Korean Mini-Mental State Examination, K-MMSE 10 points or less)
- •If there are difficulties in conducting research
- •Other patients who are judged by the principal investigator to have difficulty participating in this study.
研究组 & 干预措施
Stroke patients
Experimental
干预措施: VR-based occupational therapy (Behavioral)
结局指标
主要结局
Fugl-Meyer Assessment of upper extremity
时间窗: baseline, 4 weeks after intervention
Fugl-Meyer assessment for motor function of upper extremity in score
次要结局
- Korean version of modified Barthel index(baseline, 4 weeks after intervention)
- Korean version of mini mental state examination(baseline, 4 weeks after intervention)
- Grip and pinch strength test(baseline, 4 weeks after intervention)
- Nine-hole pegboard test(baseline, 4 weeks after intervention)
- Motion analysis(baseline, 4 weeks after intervention)
研究者
MinYoung Kim, MD, PhD
Principle investigator
Bundang CHA Hospital
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