Acute Effects of a Passive Stretching Session on the Mechanical Properties of Medial Gastrocnemius Muscle in Children With Cerebral Palsy

May 28, 2019 updated by: Centre Hospitalier Universitaire de Saint Etienne
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. This study assess efficacy of an acute high intensity and long-time stretching session of plantarflexors muscle on their viscoelasticity properties and maximal dorsiflexion angle gain. Single stretching session is characterized by high intensity and long time (5 minutes).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint Etienne, France, 42055
        • CHU de Saint Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children with cerebral palsy of the spastic type
  • Children with a maximum dorsal ankle flexion amplitude limitation of less than 10°.

Exclusion Criteria:

  • Children who have undergone surgery on the lower limbs.
  • Children with a botulinum toxin injection and/or a series of elongation casts for less than three months.
  • Children with ongoing analgesic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children with cerebral palsy of the spastic type
Other: measurement evaluated with an isokinetic dynamometer
measurement of the maximum dorsiflexion angle in degrees evaluated on an isokinetic dynamometer
Other: measurement evaluated with an 2D ultrasound
  • simultaneous recording of force torque, joint angle and myotendinous junction displacement in 2D ultrasound during 5 passive mobilization cycles of ankle flexion-extension at very low speed
  • recording of static images in 2D ultrasound representing the proximal insertion of the gastrocnemius muscle in the internal condyle of the femur, the myotendinous junction.
Other: assessment of the level of discomfort
visual analogue scale (0 = no discomfort and 10 = maximal discomfort)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
slope of the torque curve force-ankle joint angle in the joint area -25° plantar flexion/maximum dorsal flexion
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum dorsal flexion angle of ankle, knee in maximum extension position
Time Frame: at 5 minutes
at 5 minutes
slope of the force-displacement torque curve myotendinous junction of the Sural Triceps in the articular sector -25° plantar flexion/maximum dorsal flexion
Time Frame: at 5 minutes
at 5 minutes
lengths of the musculotendinous unit of the Triceps Sural muscle, the muscular body of the gastrocnemius muscle and the Achilles tendon in cm measured at rest, knee in maximum extension position, ankle angle in neutral plantar/dorsal flexion position.
Time Frame: at 5 minutes
at 5 minutes
visual analogue scale of discomfort
Time Frame: at 5 minutes
0 = not discomfort and 10 = maximal discomfort
at 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Vincent GAUTHERON, CHU de Saint Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2018

Primary Completion (Actual)

November 28, 2018

Study Completion (Actual)

November 28, 2018

Study Registration Dates

First Submitted

October 18, 2018

First Submitted That Met QC Criteria

October 19, 2018

First Posted (Actual)

October 22, 2018

Study Record Updates

Last Update Posted (Actual)

May 30, 2019

Last Update Submitted That Met QC Criteria

May 28, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18CH121
  • ANSM (Other Identifier: 2025-A01443-46)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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