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

NCT ID: NCT03565172

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-02

Study Completion Date

2018-07-26

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy, Spastic Children, Only

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The methodology used is : Single Case Experimental Design (SCED).
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

isokinetic dynamometer with ultrasound

Intervention Type 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.

Visual Analog Scale (VAS)

Intervention Type OTHER

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

Stretching

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type OTHER

Stretching

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vincent GAUTHERON, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

18CH033

Identifier Type: -

Identifier Source: org_study_id

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