跳至主要内容
临床试验/NCT00356343
NCT00356343Unknown1 期

Strength Training Using NMES for Children With Cerebral Palsy

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2004年7月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
45
试验地点
2
主要终点
Antagonist coactivation during an agonist MVIC

研究概览

简要总结

The purpose of this study is to determine if using high-intensity, short-duration, intermittent neuromuscular electrical stimulation (NMES) is better than volitional exercise in increasing quadriceps femoris and triceps surae force-generating potential and gross motor function in children with cerebral palsy.

详细描述

The overall goal of this study is to determine if using high-intensity, short-duration, intermittent neuromuscular electrical stimulation (NMES) is better than volitional exercise in increasing quadriceps femoris and triceps surae force-generating potential and gross motor function in children with cerebral palsy. This study consists of a randomized controlled trial in which the effects of NMES applied to the quadriceps femoris and triceps surae are compared to the effects of volitional isometric exercise and a non-exercising control group. This project assesses the ability of NMES to increase muscle force generating ability, the mechanisms behind changes in force generating ability, and the effects of training on spatiotemporal parameters of gait and gross motor function in children with cerebral palsy.

Subjects is the NMES group will be implanted with percutaneous electrodes in the medial and lateral heads of the gastrocnemius and the quadriceps (3 electrodes in each lower extremity, implanted bilaterally). During the intervention phase, these subjects will undergo 15 electrically-elicited contractions in each of the implanted muscle groups three times/week (at home), while positioned on an exercise board to maintain good alignment and facilitate isometric contractions. Subjects in the volitional group will perform 15 isometric contractions in each muscle group (quadriceps, triceps surae), while positioned on an exercise board. The non-exercise control group will continue with typical activities, but no intervention will be administered. Subjects are assessed at baseline, 6 weeks into the intervention, 12 weeks into the intervention (at which point the intervention is withdrawn), and at a follow-up assessment 12 weeks after the withdrawal of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children ages 7-12 years old
  • Diagnosis of spastic diplegic cerebral palsy
  • GMFCS level of II or III (able to walk indoors and outdoors with or without an assistive device)
  • PROM requirements (<10 degree hip flexion contracture, >20 degrees of hip abduction, < 5 degrees of knee flexion contracture, > 45 degree popliteal angle, ankle dorsiflexion to neutral with knee extension)
  • Sufficient cognitive/communication skills to perform volitional muscle contractions and complete data collection procedures

排除标准

  • Significant orthopedic impairments (hip MIGR > 40%, significant scoliosis)
  • Must be at least one year post orthopedic surgery
  • Must be at least 6 months post botulinum toxin injections
  • Uncontrolled seizure activity

结局指标

主要结局

Antagonist coactivation during an agonist MVIC

时间窗: Pre, Mid, Post, Washout

Contractile properties as assessed via electrically-elicited tests

时间窗: Pre, Mid, Post, Washout

Fatiguability of muscle as assessed via electrically-elicited tests

时间窗: Pre, Mid, Post, Washout

Muscle cross-sectional area of quadriceps femoris and triceps surae (via MRI with fat suppression)

时间窗: Pre, Mid, Post, Washout

Timed Up and Go

时间窗: Pre, Mid, Post, Washout

Force generating ability of quadriceps femoris and triceps surae (MVIC)

时间窗: Pre, Mid, Post, Washout

Voluntary muscle activation during a Maximal Volitional Isometric Contraction (MVIC)

时间窗: Pre, Mid, Post, Washout

Spatiotemporal parameters of gait

时间窗: Pre, Mid, Post, Washout

Gross Motor Function Measure

时间窗: Pre, Mid, Post, Washout

Parent and child report via questionnaires (PODCI, COPM)

时间窗: Pre, Mid, Post, Washout

次要结局

未报告次要终点

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih

研究点 (2)

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