Effects of Modified Constraint-induced Movement Therapy With and Without Electrical Stimulation on Range of Motion, Muscle Strength, and Motor Function in ERB's Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Medical Research Council (MRC) Scale
研究概览
简要总结
ERB's palsy is an injury of upper section of the brachial plexus (C5-6) leading to an internally rotated and adducted shoulder and a pronated forearm. Modified constraint-induced movement therapy improves the functionality of the affected limb, while electrical stimulation helps in the improvement of active range of motion and muscle strength in ERB's palsy patients. This study aims to investigate the effects of modified constraint-induced movement therapy with and without electrical stimulation on range of motion, muscle strength, and motor functions in patients with ERB's Palsy.
详细描述
This randomized clinical trial will be conducted at the Children's Hospital. The sample size will consist of 34 participants. Participants who meet the inclusion criteria will be randomly allocated into two groups using an online randomization tool; Group A will receive modified constraint-induced movement therapy with electrical stimulation and Group B will receive modified constraint-induced movement therapy only. Both groups will receive routine physical therapy as a part of treatment. All participants will receive a 60-minute session, 6 times a week for 16 weeks.
Universal Goniometer will be used to assess range of motion, the Medical Research Council Scale for muscle strength, and the Active Movement Scale for motor function at baseline, 4th, 8th, 12th, and 16th weeks after treatment discontinuation. The data will be analyzed using SPSS version 26 for Windows software.
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)
盲法说明
The study would be single-blinded as the assessor of the study would be kept blind to the treatment groups to which patients will be allocated.
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with a confirmed diagnosis of ERB's palsy.
- •Muscle power of the affected limb should be between 1 to
- •Active finger range of motion,10-degree wrist extension, and thumb abduction.
排除标准
- •Children having contracture and stiffness of affected limb.
- •Muscle power of affected limb 0 or
- •Children with cerebral palsy, visual, hearing, and cognitive problems, or any neuromuscular, and skeletal disorders.
- •Previous history of neurological and orthopedic surgery
结局指标
主要结局
Medical Research Council (MRC) Scale
时间窗: 16 weeks
It is scale used for testing muscle strength, ranging from Grade 5 (movement through full ROM with maximum resistance against gravity), Grade 4 (movement through full ROM with moderate resistance against gravity), Grade 3 (movement through full ROM without resistance against gravity), Grade 2 (movement through full ROM with gravity eliminated), Grade 1 (flicker of movement) to Grade 0 (no apparent contraction).
Active Movement Scale
时间窗: 16 weeks
It is used to quantify movement and assess upper limb motor function. It assesses 15 joint motions (range of motion and muscle strength) from the shoulder to the hand on an 8-point scale (0 ¼ no muscle tone or contraction when gravity is removed, 7 ¼ full range against gravity).
Standard universal goniometer
时间窗: 16 weeks
It is a device used to measure the range of motion of joints. It consists of four parts: body, fulcrum, stationary, and the moving arm.
次要结局
未报告次要终点