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

Not Applicable

Terminated

• Conditions: Cerebral Palsy, Spastic; Children, Only
• Interventions: Diagnostic Test: isokinetic dynamometer with ultrasound; Other: Visual Analog Scale (VAS); Diagnostic Test: Stretching

• Registration Number: NCT03565172
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-06-12
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-21
• Study Start: 2018-07-02
• Primary Completion: 2018-07-26
• Study Completion: 2018-07-26
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children with spastic cerebral palsy	Visual Analog Scale (VAS)	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.
Children with spastic cerebral palsy	Stretching	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.
Children with spastic cerebral palsy	isokinetic dynamometer with ultrasound	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France