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临床试验/NCT03361930
NCT03361930Unknown不适用

Electromyographic Comparison of Muscle Activity in Children With Spastic Unilateral Cerebral Palsy During Walking With Two Different Types of Hinged Ankle-foot Orthoses

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年10月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
Median frequency

研究概览

简要总结

The aim of this study is to investigate if ankle-foot orthoses affect changes in muscle activity of children with spastic unilateral cerebral palsy during walking.

To minimize investigator variability, the same orthotist CO, clinical gait analyst GA and physiotherapist PT will perform their designated functions for all participants.

Each subject will be required to attend three appointments.

First appointment: CO takes a lower leg cast of the involved side; the cast is taken with the ankle and hindfoot corrected to neutral position.

Second appointment: CO fits the tone-reducing ankle-foot orthosis which entails trimming the device to fit footwear, checking the orthotic device restricts plantarflexion and ensuring comfortable and functional fit. The device is modified with holes for electrode placement at locations for tibialis anterior and gastrocnemius identified by PT.

The child receives the tone-reducing ankle-foot orthosis and is instructed to use this orthotic device on a daily basis for the next four weeks to grow accustomed to the tone-reducing stimuli which may require some acclimatization.

Third appointment: A clinical examination is conducted by PT. Surface gel electrodes are then attached while the participant is instructed in individual muscle activation tests; SENIAM guidelines will be followed for electrode placement and skin preparation, aside from hamstrings and rectus femoris which will follow amended instructions in line with the scientific literature.

GA quality checks the raw electromyography (EMG) signals by visual inspection during the isolated muscle activation tests and during a dynamic trial for movement artefacts, cross-talk, baseline drift and good noise-to-signal ratio.

Reflective markers are then applied in accordance with Plug-in Gait lower body model by PT to collect kinematic and kinetic data.

A resting trial is collected to establish the baseline activity level for each muscle.

The participant is instructed to walk at a self-selected speed along the walkway. Dynamic trials continue until two clean strikes to the middle force plate are collected for the involved leg. Barefoot data is collected first while any additional modifications necessary for electrode placement are made to the ankle-foot orthoses. The order of the orthotic conditions is randomized.

Data will be recorded confidentially using reference codes for participants and stored on a secure server with designated space allocated by the hospital.

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 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Spastic unilateral cerebral palsy (hemiplegic)
  • Use of an ankle-foot orthosis (AFO) during walking because of equinus in the ankle,
  • Excessive plantarflexion during walking
  • Gross Motor Function Classification System (GMFCS) I or II

排除标准

  • Orthopedic surgery on the involved lower limb during the previous 12 months
  • Treated with BTX-a in muscles of the involved lower limb during the previous 6 months
  • Operated with selective dorsal rhizotomy (SDR)
  • Passive dorsiflexion in the ankle, passive extension of the knee and hip < 0 degrees (no fixed contractures)

研究组 & 干预措施

CP participants

Experimental

Single-day data collection for walking conditions; barefoot, with plain ankle-foot orthosis (flat foot plate) on involved side, with tone-reducing ankle-foot orthosis on involved side.

干预措施: Ankle-foot orthosis (Device)

结局指标

主要结局

Median frequency

时间窗: 30 minutes

Median frequency \[uV\] representing firing frequency for each muscle. Averaged for gait cycles from two trials for each condition.

Root-mean-square (RMS)

时间窗: 30 minutes

RMS to quantify difference in firing amplitude between conditions; normalized against resting RMS value for same muscle.

Muscle activity on/off times

时间窗: 30 minutes

Linear electromyography profiles of muscle activity (high-pass filtered, rectified and low-pass enveloped) for medial gastrocnemius, tibialis anterior, medial hamstrings, rectus femoris and vastus lateralis during walking. For each condition, gait cycles from two trials will be averaged. Signals will be synchronized to the gait cycle by foot contact/foot off events and normalized to max dynamic peak. On/off times will be defined as a percentage of max dynamic peak.

次要结局

  • Ankle moment, sagittal plane(30 minutes)
  • Ankle kinematic graph, sagittal plane(30 minutes)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ann-Britt Huse

Principal investigator

Oslo University Hospital

研究点 (2)

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