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

NCT03565172 | Terminated

• 2 other identifiers: 18CH033ID-RCB
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic; Children, Only

Keywords

cerebral palsy; stretching; isokinetic dynamometer; ultrasound; ankle; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Maximal dorsiflexion angle

  up to 12 weeks

• Slope of the torque- MyoTendinous Junction (MTJ) displacement

  up to 12 weeks

• MyoTendinous Junction (MTJ) displacement of muscle triceps sural

  up to 12 weeks

• muscle triceps sural, muscle body of the medial gastrocnemius muscle and Achilles tendon

  up to 12 weeks

• discomfort level

  up to 12 weeks

Study Arms (1)

Children with spastic cerebral palsy

EXPERIMENTAL

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; Other: Visual Analog Scale (VAS); Diagnostic Test: Stretching

Interventions

isokinetic dynamometer with ultrasound DIAGNOSTIC_TEST

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.

Children with spastic cerebral palsy

Visual Analog Scale (VAS) OTHER

the discomfort level will be measured by Visual Analog Scale (VAS) completed by children. 0 = no discomfort and 10 = maximum discomfort

Children with spastic cerebral palsy

Stretching DIAGNOSTIC_TEST

the ankle of children will be mobilized for 5 minutes (first two weeks) to 10 minutes (last two weeks).

Children with spastic cerebral palsy

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Ultrasonography; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Vincent GAUTHERON, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The methodology used is : Single Case Experimental Design (SCED).

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 21, 2018
• Study Start: July 2, 2018
• Primary Completion: July 26, 2018
• Study Completion: July 26, 2018
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)