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

• ClinicalTrials.gov Identifier: NCT02960932
• Recruitment Status: Completed
• First Posted: November 10, 2016
• Last Update Posted: September 14, 2017
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Saint Etienne

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Gait; Child Development; Hemiplegic	Device: ultrasound scanner	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Reproducibility Inter-session of the Measurement Elastography of the Passive Stiffness of Medial Beams of Gastrocnemius Muscle of the Hemiplegic Cerebral Child.
• Actual Study Start Date: February 21, 2017
• Actual Primary Completion Date: March 10, 2017
• Actual Study Completion Date: March 10, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Measure of elasticity modulus [ Time Frame: 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).

Secondary Outcome Measures :

1. Measure of force couple [ Time Frame: 7 days ]
   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.
2. Measure of fascicular length [ Time Frame: 7 days ]
   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.
3. Measure of pennation angle of the muscular fascicle [ Time Frame: 7 days ]
   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.
4. Measure of elasticity modulus [ Time Frame: 7 days ]
   Measure of elasticity modulus at the medial bundle of the gastrocnemius muscle in rest position kilopascals (kPa).
5. Measure of muscle stiffness [ Time Frame: 7 days ]
   Difference of muscle stiffness evaluated between the paretic and no paretic member.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

France

CHU de Saint Etienne

Saint Etienne, France, 42055

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT02960932
• Other Study ID Numbers: 1608112; 2016-A01558-43 ( Other Identifier: ANSM )
• First Posted: November 10, 2016
• Last Update Posted: September 14, 2017
• Last Verified: March 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

Hemiplegic; Child; Elastography; paralysis