The Effect of Functional Electrical Stimulation Technology on Gait and Balance Performance in Children With Hemiplegic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline spatial and temporal gait analysis at 3 months
研究概览
简要总结
The aim of this study will be to evaluate the effect of FES on stimulation of the anterior tibial group by using the WalkAide foot drop stimulator on improving walking and balance abilities in children with hemiplegic CP.
详细描述
The aim of this study will be to evaluate the effect of FES on improving walking and balance abilities in children with hemiplegic CP. Forty children with hemiplegic CP will be assigned randomly into two groups (A & B). Control group (A) will receive conventional rehabilitation program for lower limb, balance and gait training. Study group (B) will receive conventional rehabilitation program as in group (A) in addition to FES by using the WalkAide foot drop stimulator. Patients' evaluation will be carried out before and after training to assess walking ability 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
- 是
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 analysis at 3 months
时间窗: Baseline and 3 months post-intervention
Spatial and temporal gait analysis will be evaluated for every child at baseline and 3 months post-intervention using the Noraxon's Myo PRESSURE plate.
Change from baseline postural stability at 3 months
时间窗: Baseline and 3 months post-intervention
Postural stability will be 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