Effect of Functional Electrical Stimulation Versus TheraTogs on Gait and Balance in Children With Hemiplegic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from baseline spatial and temporal gait parameters at 3 months
研究概览
简要总结
To compare the effect of functional electrical stimulation (FES) versus TheraTogs on Gait and Balance in children with hemiplegic CP.
详细描述
The aim of this study was to evaluate the effect of FES versus TheraTogs on Gait and Balance in children with hemiplegic CP. Thirty children with hemiplegic CP will be assigned randomly into two groups (A & B). Group A received FES by using the WalkAide foot drop stimulator while group B received TheraTogs. Patients' evaluation will be carried out before and after training to assess gait and balance performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Their weight should be less than 40 kg.
- •The spasticity degrees of the affected lower limb will range between grades (1, 1+ & 2) according to Modified Ashworth Scale (MAS).
- •Those children functioning scores at Gross Motor Function Classification System (GMFCS) Levels I and II.
- •They can walk 10 min conditionally without an orthosis.
- •Ought to be intellectually skilled and ready to comprehend and take after directions.
- •They will have neither serious nor recurring medical complications.
- •Children's height will be more than 100 cm to fit with the Biodex balance equipment that will be used in this study to evaluate balance performance.
- •No serious hip & knee flexion tightness will be present. Knee flexion at starting contact should be between 20-40º .
- •Peroneal nerve and the proximal leg muscles ought to be in place.
- •They ought to have no significant issues influencing balance other than spasticity.
排除标准
- •Children who demonstrate skin diseases or allergic reactions to adhesive tape or any other materials used in this study.
- •Children with visual, auditory or perceptual deficits.
- •Children with surgical interference for the lower limb.
- •Children with seizures or epilepsy.
- •Children who received botulinum toxin in the lower extremity musculature during the past 6 months or who wish to receive it within the period of study, other spasticity medication within 3 months of pre-treatment testing .
- •Children with pacemakers or other diseases that are contraindicated by electrical stimulation.
结局指标
主要结局
Change from baseline spatial and temporal gait parameters at 3 months
时间窗: Baseline and 3 months post-intervention
Gait parameters were evaluated for every child at baseline and 3 months post-intervention using the Pro-Reflex motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden). For the purpose of this study four commonly used and reliable gait parameters were examined: stride length, step length, velocity, cadence, and stance and swing phase percentage.
Change from baseline postural stability at 3 months
时间窗: Baseline and 3 months post-intervention
Postural stability were evaluated at baseline and 3 months post-intervention using the Biodex Balance System (BBS) (Balance System SD, Shirely, NY, USA).
次要结局
未报告次要终点
研究者
Shamekh Mohamed El-Shamy
Professor
Umm Al-Qura University