Effect of Radial Shock Wave Therapy on Calf Muscle Tone, ROM, Gross Motor Scale, Plantar Surface and Quality of Life in Patients With Cerebral Palsy: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- calf muscle tone
研究概览
简要总结
the aim of this study to assess different outcome measures after applying standard physical therapy plus radial shockwave and compare the results with another group who received standard treatment only.
Design: double-blinded (assessor and data analyzer)
Methods: This study will be conducted in 4 rehabilitation facilities, Times for 1 month of intervention Assessment timeline: 3 times (T0: at baseline, T1: at 4 weeks, T2: follow up at 3 months. Outcome measures: the Modified Ashworth scale (MAS), Ankle ROM, Plantar surface area, Gross motor function, and quality of life
详细描述
the current study is a randomized controlled trial in which the researchers intended to examine the effect of adding radial shockwave therapy to standard physical therapy on the status of calf muscle spasticity and consequent effects on gross motor function, ankle joint ROM, plantar surface area, and quality of life.
the experimental intervention will consist of 4 sessions of radial shockwave applied to the bulkiest area of the calf muscle in children having spastic cerebral palsy. participants will receive 1 session of radial shockwave per week and will continue their regular physical therapy as usual (3 sessions per week).
outcome assessment will be conducted 3 times: at baseline, after the end of the treatment program, and at 3 months follow-up.
the tools that will be used to collect data will be:
- Modified Ashworth scale for muscle tone.
- Goniometer for Ankle ROM.
- EMed force platform for plantar surface area
- Gross motor function scale for gross motor function
- Cerebral Palsy Quality of Life Questionnaire for quality of life assessment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 8-14
- •diagnosed with spastic CP
- •ability to walk alone or with assistance
- •grades 1 -4 on Gross Motor Function Classification System
- •at least score 1 on the Modified Ashworth Scale (MAS)
- •ability to attend the treatment program and the outcome assessment sessions.
排除标准
- •patients who received a botulinum toxin injection in the calf muscle during the last six months
- •structural contracture of the calf muscle
- •surgery in the lower extremity during the previous year
- •those experiencing pain in the lower limbs
- •severe associated neurological diseases as epilepsy
- •medications affecting peripheral muscle tone.
结局指标
主要结局
calf muscle tone
时间窗: at follow up (3months after the end of the treatment)
the Modified Ashworth scale (MAS) will be used to assess the tone of the affected calf muscle. the test will be done by moving the ankle joint passively and assess quality of movement and resistance provided by the tissues. scores ranged from 0 to 4 where 0 means normal and 4 means higher spasticity
plantar surface area
时间窗: at follow up (3months after the end of the treatment)
E Med force platform will be used to assess plantar surface area during normal relaxed standing. it will be expected that larger surface area indicate improvement in calf muscle spasticity
gross-motor function
时间窗: at follow up (3months after the end of the treatment)
Gross Motor Function Measure scale will be used to assess changes in gross motor. function in cerebral palsy patients. the score will be determined according to the tasks the patient can do. where lower score (1) for nealy normal patients while score of (5) will indicate lowest gross motor abilities.
ankle joint ROM
时间窗: at follow up (3months after the end of the treatment)
traditional goniometer will be used to measure active ROM of the ankle joint. the patient will be in supine position during assessment
次要结局
- cerebral palsy quality of life questionnaire(at follow up (3months after the end of the treatment))
研究者
Hisham Mohamed Hussein
principal investigator
University of Hail