Effects of Functional Electrical Stimulation Neuroprosthesis in Children With Hemiplegic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- peak ankle dorsiflexion range during swing phase in gait
研究概览
简要总结
The purpose of this study is to evaluate how a functional electrical stimulation (FES) device worn on the lower leg effects how children (ages 6-17 years) with hemiplegic cerebral palsy walk and perform other functional activities.
The investigators expect to find that wearing the functional electrical stimulation device will improve walking and other functional activities of children with hemiplegic cerebral palsy. Participants will be trained in use of the device and will be required to wear it daily for 3 months. Each participant will be evaluated before beginning the intervention and after completing the intervention. This study will provide important information regarding the benefits of this treatment intervention in children with hemiplegic cerebral palsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hemiplegic Cerebral Palsy
- •Gross Motor Function Classification System (GMFCS) I or II
- •Age 6-17 years inclusive
- •Demonstrate foot drop during gait without wearing ankle foot orthosis
- •Tolerance to neuroprosthesis stimulation
- •Physician referral to participate in intervention
- •Passive dorsiflexion to at least neutral with knee extended
- •Available to travel to and from study visits
- •Ability to follow instructions and cooperate with study protocol
- •Caregiver reads and understands English
排除标准
- •Any metal implants containing electrical circuitry
- •Continuous regular use of neuroprosthesis stimulation previous to study enrollment
- •Previous orthopaedic procedure involving tibialis anterior muscle at any time
- •Previous orthopaedic procedure to affected limb in the last year
- •Botulinum toxin administered within the past 3 months, or plans for such treatment during the course of the study
- •Any condition that PI feels would limit ambulatory progress (e.g. arthritis, uncontrolled seizures)
研究组 & 干预措施
FES neuroprosthesis to dorsiflexors on affected side
Participants will use FES neuroprosthesis to dorsiflexors on affected leg for 3 months at home.
干预措施: FES neuroprosthesis to dorsiflexors on affected leg (Other)
结局指标
主要结局
peak ankle dorsiflexion range during swing phase in gait
时间窗: will be assessed at baseline and 3 months after continous use of neuroprosthesis
次要结局
- gait efficiency(after 3 months of neuroprosthesis use)