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

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.

Study Overview

• Status: Completed
• Conditions: Gait; Child Development; Hemiplegic
• Intervention / Treatment: Device: ultrasound scanner

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint Etienne, France, 42055
    • Chu de Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hemiplegic cerebral child; Ultrasound scanner used to the SSI technical reproducibility.	Device: ultrasound scanner; Ultrasound scanner used to the SSI technical reproducibility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Measure of elasticity modulus	Measure of elasticity modulus at the medial bundle of the gastrocnemius muscle in rest position kilopascals (kPa).	7 days
Measure of muscle stiffness	Difference of muscle stiffness evaluated between the paretic and no paretic member.	7 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Vincent Gautheron, MD PhD, Centre Hospitalier Universitaire de Saint Etienne

Publications and helpful links

General Publications

• Boulard C, Gautheron V, Lapole T. Reliability outcomes and inter-limb differences in ankle joint stiffness in children with unilateral cerebral palsy depend on the method of analysis. J Electromyogr Kinesiol. 2019 Dec;49:102353. doi: 10.1016/j.jelekin.2019.102353. Epub 2019 Aug 23.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2017
• Primary Completion (Actual): March 10, 2017
• Study Completion (Actual): March 10, 2017

Study Registration Dates

• First Submitted: November 8, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimate): November 10, 2016

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Child; Elastography; paralysis; Hemiplegic
• Other Study ID Numbers: 1608112; 2016-A01558-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No