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临床试验/NCT06532981
NCT06532981
招募中
不适用

The Effect of the Ankle-foot Orthosis on Muscle Activity in the Lower Limbs in Children With Cerebral Palsy

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 30 人2023年1月6日

概览

阶段
不适用
干预措施
Ambulatory children with spastic CP
疾病 / 适应症
Spastic Cerebral Palsy
发起方
Universitaire Ziekenhuizen KU Leuven
入组人数
30
试验地点
1
主要终点
EMG co-activation
状态
招募中
最后更新
2个月前

概览

简要总结

Children with cerebral palsy (CP) have altered gait patterns as a result of primary and secondary symptoms. Ankle-foot orthoses (AFOs) are frequently used to improve their gait. Despite evidence of AFO-effects on gait kinetics and -kinematics, the effects on muscle activity remain unclear.

This study will investigate the effect of AFOs on the amplitude and timing, as well as the co-activation of lower limb muscle activity in children with spastic CP.

详细描述

With a prevalence of two to three per 1000 live births, Cerebral Palsy (CP) is the most common motor disability of childhood. Improving disturbed gait in ambulatory children with CP is an important treatment goal because it is associated with functional independence and participation of children in the society. It is a common practice to prescribe ankle-foot orthoses (AFO) for ambulatory children to improve their gait, prevent secondary deformities, provide an improved base of support, and compensate for muscle weakness. Previous research highlighted that there is a direct effect on the muscle activity of the distal muscles and an indirect effect on the proximal muscles. However, the impact of the AFO on the muscle activity of the plantar and dorsiflexors is clinically relevant since reduced muscle activity may lead to muscle atrophy and altered motor control. Therefore, more research is needed on the effect of AFOs on the medial gastrocnemius and the tibialis anterior, in both unilaterally and bilaterally involved children. Moreover, the impact of the AFO on the muscle activity of the quadriceps, apart from the hamstrings, needs to be further explored as well. The purpose of the current study is to investigate the effect of the AFO on muscle activity in the distal and proximal leg muscles of children with CP while walking. On the measurement day, subjects will first receive a standard clinical examination preceding the clinical overground three-dimensional gait analysis (3DGA) that is planned as a routine clinical follow-up at the CMAL (clinical motion analysis laboratory), extended with an additional 3DGA on the treadmill. The treadmill gait laboratory and overground gait laboratory are across the hall from each other, which makes it possible for the subject to walk from one to the other gait laboratory in just a minute. During the 3DGA, kinematic, kinetic and EMG-data will be collected.

注册库
clinicaltrials.gov
开始日期
2023年1月6日
结束日期
2026年12月31日
最后更新
2个月前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Kaat Desloovere

Prof. dr.

Universitaire Ziekenhuizen KU Leuven

入排标准

入选标准

  • Gross Motor Function Classification System (GMFCS) level I - III
  • CP (bilateral \& unilateral)
  • Age: 6 - 17 years
  • Prescribed AFO by the medical team (as part of the standard care)

排除标准

  • Severe contractures or spasticity, which makes it impossible to wear a conventional AFO
  • Cognitive or visual impairment that hinder them to understand instructions
  • Previous surgery on bones and/or muscles of the legs in the last 12 months prior to assessment
  • Presence of ataxia or dystonia

研究组 & 干预措施

Ambulatory children with spastic CP

Ambulant children with cerebral palsy between 6 and 17 years old with a consistent gait pattern. They have prescribed ankle-foot orthoses by the medical team as part of the standard care.

结局指标

主要结局

EMG co-activation

时间窗: One measurement of 150 minutes

The co-activation was calculated by defining the synchronised activations of the agonist and antagonist muscles. To quantify the co-activation, the on- and off-timing of the muscle activity needed to be defined for the rectus femoris, the medial hamstrings, the gastrocnemius and the tibialis anterior.

EMG-waveform amplitude & timing

时间窗: One measurement of 150 minutes

The averaged time-normalized continuous EMG-waveforms for each walking condition (i.e., barefoot, AFO, overground and on the treadmill) the following muscles: the quadriceps (m. rectus femoris, m. vastus lateralis), the hamstrings (m. semitendinosus, m. biceps femoris) and the shank (m. gastrocnemius medialis, m. tibialis anterior).

研究点 (1)

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