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

NCT02960932 | Completed

• 2 other identifiers: 16081122016-A01558-43
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Gait; Child Development; Hemiplegic

Keywords

Hemiplegic; Child; Elastography; paralysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Measure of force couple

  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 muscle stiffness

  7 days

Study Arms (1)

hemiplegic cerebral child

EXPERIMENTAL

Ultrasound scanner used to the SSI technical reproducibility.

Device: ultrasound scanner

Interventions

ultrasound scanner DEVICE

Ultrasound scanner used to the SSI technical reproducibility.

hemiplegic cerebral child

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

Related Publications (1)

• 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.

  PMID: 31473451 DERIVED

MeSH Terms

Conditions

Paralysis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vincent Gautheron, MD PhD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 10, 2016
• Study Start: February 21, 2017
• Primary Completion: March 10, 2017
• Study Completion: March 10, 2017
• Last Updated: September 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)