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

Child Development Clinical Trial

— ELASTOREPRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02960932
• Other study ID #: 1608112
• Secondary ID: 2016-A01558-43
• Status: Completed
• Phase: N/A
• First received: November 8, 2016
• Last updated: September 13, 2017
• Start date: February 21, 2017
• Est. completion date: March 10, 2017

Study information

• Verified date: March 2017
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 10, 2017
• Est. primary completion date: March 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Child Development
• Gait
• Hemiplegic

Intervention

Device:
• ultrasound scanner
Ultrasound scanner used to the SSI technical reproducibility.

Locations

Country	Name	City	State
France	CHU de Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of elasticity modulus	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).	7 days
Secondary	Measure of force couple	Stored measure at the passive mobilization of the ankle in position of maximal dorsal flexion; calculation of yield couple of joint force-angle in nanometer.	7 days
Secondary	Measure of fascicular length	To measure at the medial bundle of the gastrocnemius muscle at the passive mobilization of the ankle in the selected joint sector (30 degree in plantar and maximal dorsal flexion); calculation of the difference of fascicular length in millimeter between the extreme position of joint sector: 30 degree in plantar and maximal dorsal flexion.	7 days
Secondary	Measure of pennation angle of the muscular fascicle	To measure at the medial bundle of the gastrocnemius muscle at the passive mobilization in the selected joint sector in degree; calculation of the difference of pennation angle of the muscular fascicle between the extreme position of joint sector: 30 degree in plantar and maximal dorsal flexion.	7 days
Secondary	Measure of elasticity modulus	Measure of elasticity modulus at the medial bundle of the gastrocnemius muscle in rest position kilopascals (kPa).	7 days
Secondary	Measure of muscle stiffness	Difference of muscle stiffness evaluated between the paretic and no paretic member.	7 days