Efficacy of a Long Term, High Intensity and Long Time Stretch Training Program on Viscoelasticity Plantarflexors Muscle in Children With Cerebral Palsy (CP). (LONGSTRETCH PC)

Children with cerebral palsy present early in the childhood altered muscular properties, as soon as structural or stiffness. In the gastrocnemius muscle, altered muscular properties are characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion.

Study Overview

• Status: Terminated
• Conditions: Children, Only; Cerebral Palsy, Spastic
• Intervention / Treatment: Diagnostic test: isokinetic dynamometer with ultrasound; Other: Visual Analog Scale (VAS); Diagnostic test: Stretching

Detailed Description

This study assess efficacy of a long term stretching program of plantarflexors muscle on their viscoelasticity properties and maximal dorsiflexion angle gain. Stretching program is characterized by 3 phases: baseline, intervention and follow-up.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children aged 8 to 16 years
• Children diagnosed spastic cerebral palsy
• Children with decrease maximal dorsiflexion angle under +5° in the last four weeks
• Children who don't understand instructions

Exclusion Criteria:

• Children who had damage orthopedics or surgical operation contraindicating realization of the experimental protocol
• Hospitalization incompatible with the progress of the protocol.
• Children who had botulinum injection, extensions casts or the implementation of new equipment (night or day orthosis) for less than three months or the progress of the protocol.
• Children having analgesic treatment in progress

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• 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: Children with spastic cerebral palsy; Children with spastic cerebral palsy will be included. They will have 3 phases: Baseline: 4, 5 or 6 evaluations; Intervention: 9 evaluations before and after every stretching session; Follow-up: 4, 5 or 6 evaluations The evaluation part will be composed of isokinetic dynamometer with ultrasound and Visual Analog Scale (VAS). The number of evaluations at baseline and follow-up will be randomized before the study by Single Case Experimental Design (SCED) methodology.

Diagnostic test: isokinetic dynamometer with ultrasound; children are lying prone on a isokinetic dynamometer with ultrasound which stretches spastic and paretic plantarflexors muscles very slowly until maximal torque tolerated. The parameters can be measured.; Other: Visual Analog Scale (VAS); the discomfort level will be measured by Visual Analog Scale (VAS) completed by children. 0 = no discomfort and 10 = maximum discomfort; Diagnostic test: Stretching; the ankle of children will be mobilized for 5 minutes (first two weeks) to 10 minutes (last two weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
slope of the torque-angle curve	Analysis of the slope of the torque-angle curve in Nm/°. It is measured by isokinetic dynamometer with ultrasound.	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal dorsiflexion angle	Analysis of the maximal dorsiflexion angle in degrees. It is measured by isokinetic dynamometer with ultrasound.	up to 12 weeks
Slope of the torque- MyoTendinous Junction (MTJ) displacement	Analysis of the Slope of the torque- MyoTendinous Junction (MTJ) displacement in cm/°. It is measured by isokinetic dynamometer with ultrasound.	up to 12 weeks
MyoTendinous Junction (MTJ) displacement of muscle triceps sural	Analysis of the MyoTendinous Junction (MTJ) displacement of muscle triceps sural in cm. It is measured by isokinetic dynamometer with ultrasound.	up to 12 weeks
muscle triceps sural, muscle body of the medial gastrocnemius muscle and Achilles tendon	Correlation of the length of Musculo-Tendinous Unit (MTU) of muscle triceps sural, muscle body of the medial gastrocnemius muscle and Achilles tendon. It is measured by isokinetic dynamometer with ultrasound.	up to 12 weeks
discomfort level	Analysis of the discomfort level. It is measured by Visual Analog Scale (VAS) completed by children. 0 = no discomfort and 10 = maximum discomfort	up to 12 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Vincent GAUTHERON, PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2018
• Primary Completion (Actual): July 26, 2018
• Study Completion (Actual): July 26, 2018

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: ultrasound; children; ankle; cerebral palsy; stretching; isokinetic dynamometer
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: 18CH033; ID-RCB (Other Identifier: 2023-A01937-38)

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