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

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ClinicalTrials.gov Identifier: NCT03565172
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy, Spastic Children, Only Diagnostic Test: isokinetic dynamometer with ultrasound Other: Visual Analog Scale (VAS) Diagnostic Test: Stretching Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 3 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The methodology used is : Single Case Experimental Design (SCED).
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Efficacy of a Long Term, High Intensity and Long Time Stretch Training Program on Viscoelasticity Plantarflexors Muscle in Children With Cerebral Palsy (CP).
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. slope of the torque-angle curve [ Time Frame: 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 :
  1. Maximal dorsiflexion angle [ Time Frame: up to 12 weeks ]
    Analysis of the maximal dorsiflexion angle in degrees. It is measured by isokinetic dynamometer with ultrasound.

  2. Slope of the torque- MyoTendinous Junction (MTJ) displacement [ Time Frame: 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.


  3. MyoTendinous Junction (MTJ) displacement of muscle triceps sural [ Time Frame: 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.


  4. muscle triceps sural, muscle body of the medial gastrocnemius muscle and Achilles tendon [ Time Frame: 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.


  5. discomfort level [ Time Frame: 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



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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565172


Contacts
Contact: Vincent GAUTHERON, PhD (0)477120972 ext +33 vincent.gautheron@chu-st-etienne.fr
Contact: Marie PEURIERE, CRA (0)477829272 ext +33 Marie.Peuriere@chu-st-etienne.fr

Locations
France
CHU Saint-Etienne Recruiting
Saint-Étienne, France
Principal Investigator: Vincent GAUTHERON, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Vincent GAUTHERON, PhD CHU Saint-Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03565172     History of Changes
Other Study ID Numbers: 18CH033
ID-RCB ( Other Identifier: 2018-A00709-46 )
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
cerebral palsy
stretching
isokinetic dynamometer
ultrasound
ankle
children

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases