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临床试验/NCT02960932
NCT02960932已完成不适用

Reproducibility Inter-session of the Measurement Elastography of the Passive Stiffness of Medial Beams of Gastrocnemius Muscle of the Hemiplegic Cerebral Child.

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2017年2月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Measure of elasticity modulus

研究概览

简要总结

Muscles, paretics and spastics, of cerebral palsy children have very early, for growth (three at five aged), every alteration of theirs properties. Gastrocnemius muscle, often reaches on the cerebral palsy, characterised by a modification of the structure (volume decrease) and the elasticity (increase of the passive stiffness). Every alterations of the muscular property have impact clinic and functional important. The many treatments of orthopaedic targeting (lengthening of cast, injections of botulinic toxin), repeated to a multiple recovery during the growth influences the muscular characteristics. There is a real interest to measure the muscular property development during children's growth.

详细描述

Elastography is a technical assessment of characteristic of the soft tissues. In this area, the method " Supersonic Shear Imaging® (SSI) " provide an important technological change measuring, swiftly and no invasive, a elasticity modulus reflecting the property visco-elastic of the muscle. A lot of ex vivo study led in isolated muscle and in vivo in healthy adults demonstrated the validity of the method SSI on the evaluation of the passive stiffness from a number of muscle group whose the gastrocnemius muscle. The main objective of this study must be checked the intersession reproducibility of the method SSI on the evaluation of the passive stiffness at the medial bundle of the gastrocnemius muscle therefore their passive lengthening in cerebral palsy children. The secondary objective is to test the correlation level of the relation elasticity modulus/ joint angle and couple force-angle obtained throughout the passive lengthening at the medial bundle of the gastrocnemius muscle in cerebral palsy children.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Parents affiliated or entitled to a social security;
  • Children diagnosed spastic cerebral paralyzed, with a clinical picture of hemiplegia infantile cerebral;
  • Children walking GMFCS (Gross Motor Functional Classification System) between I and III;
  • Children with spasticity level in the paralysing gastrocnemius muscle greater than or equal X1, VII, on the scale of Tardieu and 2 on the Ashworth scale.
  • Children aged 5 to 12 years.
  • Children can understand and follow the simple instructions in the examination process.
  • Consent signed by the holder of parental authority.

排除标准

  • Children with concomitant muscle disease (myopathy ...).
  • Children who received another treatment to target relaxant (baclofen, ... muscle relaxant) which would have begun in the months preceding the assessment.
  • Children who underwent neuro-orthopedic surgery at the where paretic members.
  • Children who received an injection of botulinic toxin for less than 15 days.
  • Children who have benefited from extensions casts for less than 7 days.
  • Children who received a therapeutic target for orthopedic (botulinum toxin, plaster of extensions, installation of equipment of lower limb) between the two sessions evaluations.
  • Children who received a physiotherapy session the day before evaluation elastography and ultrasound.

研究组 & 干预措施

hemiplegic cerebral child

Experimental

Ultrasound scanner used to the SSI technical reproducibility.

干预措施: ultrasound scanner (Device)

结局指标

主要结局

Measure of elasticity modulus

时间窗: 7 days

To measure at the medial bundle of the gastrocnemius muscle at the passive mobilization of the ankle in the joint sector following: 30 degree in plantar and maximal dorsal flexion; calculation of yield curve of elasticity modulus, joint angle in kilopascals (kPa).

次要结局

  • Measure of muscle stiffness(7 days)
  • Measure of fascicular length(7 days)
  • Measure of pennation angle of the muscular fascicle(7 days)
  • Measure of elasticity modulus(7 days)
  • Measure of force couple(7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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