Improving Gait and Balance in Children With Hemiplegic Cerebral Palsy: Gait Myoelectric Stimulator Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- Aim 1 - Improve initial contact during gait, as measured by Noraxon video software
研究概览
简要总结
This research study will see if electrical stimulation increases heel strike (heel hits the floor first when walking), decreases limp, helps muscle contraction, and improves balance in children with a hemiplegic leg. An experimental electrical stimulation device called the Gait MyoElectric Stimulator (GMES) will be used to stimulate the shin and calf muscles.
详细描述
Physical therapists focus on improving gait and balance in children with hemiplegic cerebral palsy (HCP). Functional electrical stimulation (FES) has the potential to improve strength and functional gait for children with HCP. The investigators hypothesize that a new FES system stimulating the dorsiflexor (DF) and plantarflexor (PF) muscles alternately at the correct time during gait, would lead to a significant improvement (p<.05) in foot contact, gait symmetry and balance, compared to 12 weeks of a healthy lifestyle program called 5210.
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)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who are:
- •Are age 5-18 years
- •Have been walking independently (no walker or cane) for at least 18 months.
- •Use co-contraction of DF and PF during walking based upon surface electromyography.
- •Have a diagnosis of spastic hemiplegic CP, Gross Motor Function Classification System (GMFCS) Levels I-II
排除标准
- •Children who:
- •Have passive ankle range <5 DF or < 10 PF with hip and knee extended.
- •Report uncontrolled seizures.
- •Had orthopedic surgery (for example heel cord or hamstring lengthening)
- •Have used tone reducing medications (Botox, Baclofen) in the last 6 months.
- •Wear ankle foot orthoses that limit DF/PF motion.
- •Have low motivation/tolerance for electrical stimulation.
- •Have parents/caregivers who are not able or willing to assist with the protocol for 6 months.
- •Have low tolerance to electrical stimulation in screening process.
结局指标
主要结局
Aim 1 - Improve initial contact during gait, as measured by Noraxon video software
时间窗: 12 weeks
To determine if the GMES program will improve initial contact during free speed walking (ie decrease toe first or flat foot contact, and increase heel strike). Based on visual examination of freeze frame videotaped walking patterns, "foot contact" will be scored at initial contact as either heel, foot flat, or toe. A numerical assignment will be placed for each of these contact points. Each step with the heel contact (the most optimal), will receive a score of 3. Each step with the foot flat (the less optimal), will receive a score of 2. Each step the toe contact, (the least optimal), will receive a score of 1. A total of 10 initial contacts will be examined at each testing. The numerical value of the total number of contact points will be calculated for each subject and each trial.
次要结局
- Aim 2 - Improve walking symmetry, as measured by Noraxon video software(12 weeks)
- Aim 3 - Improve balance, as measured by the Balance Subtest of the Bruininks-Oseretsky Test of Motor Proficiency (BOT2).(12 weeks)