Comparison of the Effects of Different Doses of Virtual Reality Therapy on Motor Functions in Chronic Stroke Patients - A Randomized Controlled Single-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
研究概览
简要总结
This study aimed to compare the effects of different doses of Wii Fit-based virtual reality (VR) therapy added to conventional rehabilitation in patients with chronic stroke. Forty-three patients were randomly assigned to three groups: a control group receiving conventional rehabilitation only (5 days/week, 45 min/session for 4 weeks), a VR3 group receiving conventional rehabilitation plus VR training three days per week (20 min/session, 12 sessions total), and a VR5 group receiving conventional rehabilitation plus VR training five days per week (20 min/session, 20 sessions total). Balance (Berg Balance Scale), functional independence (Functional Independence Measure), stroke-specific quality of life (SS-QOL), static postural alignment (Becure Posture Mobile), and center of pressure measurements (Becure Balance System) were assessed before treatment (T0), after treatment (T1), and at one-month follow-up (T2). This prospective, single-blind, randomized controlled trial was conducted at Istanbul Physical Medicine Rehabilitation Training and Research Hospital.
详细描述
Study Design
This was a prospective, single-blind (assessor-blinded), randomized controlled trial conducted at Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Ethical approval was obtained from the Istanbul University-Cerrahpasa Clinical Research Ethics Committee (Protocol No: 2025/28). Written informed consent was obtained from all participants prior to enrollment.
Participants
Patients with chronic stroke (onset >6 months) aged 20-75 years were screened for eligibility. Inclusion criteria: diagnosed with ischemic or hemorrhagic stroke, Mini-Mental State Examination (MMSE) score ≥18. Patients were excluded if they had an MMSE score below 18, a diagnosis of epilepsy, a diagnosis of intellectual disability, or visual and/or hearing impairment at a level that would affect participation in treatment.
Randomization
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ischemic or hemorrhagic stroke confirmed by CT or MRI
- •Chronic stroke (onset ≥ 6 months prior to enrollment)
- •Age between 20 and 75 years
- •Mini-Mental State Examination (MMSE) score ≥ 18 (or MMSE-E for illiterate patients)
- •Willingness to participate and provide written informed consent
排除标准
- •Mini-Mental State Examination (MMSE) score < 18
- •Diagnosis of epilepsy
- •Diagnosis of intellectual disability
- •Visual and/or hearing impairment at a level that would affect participation in treatment methods
研究者
Başak Can
Medical Resident
Istanbul Physical Medicine Rehabilitation Training and Research Hospital