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Clinical Trials/NCT03565172
NCT03565172TerminatedNot Applicable

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country1 target enrollmentStarted: July 2, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
1
Locations
1
Primary Endpoint
slope of the torque-angle curve

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
8 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: isokinetic dynamometer with ultrasound (Diagnostic Test)

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.

Intervention: Visual Analog Scale (VAS) (Other)

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.

Intervention: Stretching (Diagnostic Test)

Outcomes

Primary Outcomes

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 Outcomes

  • MyoTendinous Junction (MTJ) displacement of muscle triceps sural(up to 12 weeks)
  • Slope of the torque- MyoTendinous Junction (MTJ) displacement(up to 12 weeks)
  • muscle triceps sural, muscle body of the medial gastrocnemius muscle and Achilles tendon(up to 12 weeks)
  • Maximal dorsiflexion angle(up to 12 weeks)
  • discomfort level(up to 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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