Effect of Modified Constraint-induced Movement Therapy Combined With Virtual Reality on Mobility in Post-stroke Patients: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Motor Control
研究概览
简要总结
This study investigates the effectiveness of combining m-CIMT and VR to improve mobility in post-stroke patients. A non-blinded randomized controlled trial will be conducted with 32 participants divided equally into experimental and control groups using purposive sampling. The experimental group will receive m-CIMT with VR training, while the control group will receive m-CIMT with Task-Specific Functional Training. Sessions will be 30 minutes per day, 4 days a week, for 6 weeks. Outcomes will be measured using FMA-LE, BBS, DGI, TUG, and SS-QOL. The study will take place over one year at FFH and FUCP, with ethical approval from ERC FUMC.
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
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sample Selection Criteria
- •Inclusion Criteria
- •Sub-acute and chronic stroke patient >3months
- •Males and females of 40-60 years.
- •Mini-Mental State Examination score ≥24
- •FAC Scale = 3
- •Limited spasticity (0,1,1⁺) according to modified Ashworth scale
- •Adequate balance and walking ability while wearing the constraint to be eligible to participate in CIMT intervention.
排除标准
- •Patient with Severe Spasticity and pain
- •Patient of Epilepsy, Parkinson's disease and stage 4 arthritis
- •Patient with Global Aphasia
- •Individuals suffering from unstable angina, symptomatic heart failure, or uncontrolled hypertension
- •Patients with any traumatic musculoskeletal injury and surgery of lower limb
研究组 & 干预措施
m-CIMT with Task-Specific Functional Training
Begin with low-intensity exercises and progress to moderate to high intensity; session will be for about 30 minutes Warm-up for 5 minutes;one minute of rest for every five minutes of exercise For week 1-3: Assisted standing and weight shifting, Heel raises, Toe taps, Supported stepping, Unassisted standing and balance tasks will be used For week 4-6: Progressive stepping exercises, Heel-to-toe standing, Unassisted balance and coordination tasks, Advanced stepping patterns and dynamic balance challenges, Functional tasks like step-ups and lateral steps will be used 5 minutes will be given for cool down
干预措施: m-CIMT with Task-Specific Functional Training (Procedure)
m-CIMT with VR exer-games by Kinect Xbox 360
Virtual reality workout session will be for about 30 minutes Warm-up exercise will be for 5 minutes including relaxed breathing For week 1-3: Soccer and Space Bubble Pop games will be used For week 4-6: 20,000 Leaks and Rally Ball games will be used 5 minutes will be given for cool down.
干预措施: m-CIMT with VR exer-games by Kinect Xbox 360 (Procedure)
结局指标
主要结局
Motor Control
时间窗: 6 weeks
Fugl-Meyer Assessment for Lower Extremity (FMA-LE) is a standardized, stroke-specific tool designed to evaluate motor control. It demonstrates excellent reliability (ICC ≥ 0.98) and strong construct validity.
Mobility
时间窗: 6 weeks
Time Up and Go test: This test will be used to measure mobility in older adults.
次要结局
未报告次要终点