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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). (LONGSTRETCH PC)

Primary Purpose

Cerebral Palsy, Spastic, Children, Only

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
isokinetic dynamometer with ultrasound
Visual Analog Scale (VAS)
Stretching
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cerebral Palsy, Spastic focused on measuring cerebral palsy, stretching, isokinetic dynamometer, ultrasound, ankle, children

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Saint-Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children with spastic cerebral palsy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maximal dorsiflexion angle
Analysis of the maximal dorsiflexion angle in degrees. It is measured by isokinetic dynamometer with ultrasound.
Slope of the torque- MyoTendinous Junction (MTJ) displacement
Analysis of the Slope of the torque- MyoTendinous Junction (MTJ) displacement in cm/°. It is measured by isokinetic dynamometer with ultrasound.
MyoTendinous Junction (MTJ) displacement of muscle triceps sural
Analysis of the MyoTendinous Junction (MTJ) displacement of muscle triceps sural in cm. It is measured by isokinetic dynamometer with ultrasound.
muscle triceps sural, muscle body of the medial gastrocnemius muscle and Achilles tendon
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.
discomfort level
Analysis of the discomfort level. It is measured by Visual Analog Scale (VAS) completed by children. 0 = no discomfort and 10 = maximum discomfort

Full Information

First Posted
June 12, 2018
Last Updated
August 2, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT03565172
Brief Title
Efficacy of a Long Term, High Intensity and Long Time Stretch Training Program on Viscoelasticity Plantarflexors Muscle in Children With Cerebral Palsy (CP).
Acronym
LONGSTRETCH PC
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).
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
protocol with too many constraints. long protocol
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
July 26, 2018 (Actual)
Study Completion Date
July 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic, Children, Only
Keywords
cerebral palsy, stretching, isokinetic dynamometer, ultrasound, ankle, children

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The methodology used is : Single Case Experimental Design (SCED).
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children with spastic cerebral palsy
Arm Type
Experimental
Arm Description
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 Type
Diagnostic Test
Intervention Name(s)
isokinetic dynamometer with ultrasound
Intervention Description
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
Other
Intervention Name(s)
Visual Analog Scale (VAS)
Intervention Description
the discomfort level will be measured by Visual Analog Scale (VAS) completed by children. 0 = no discomfort and 10 = maximum discomfort
Intervention Type
Diagnostic Test
Intervention Name(s)
Stretching
Intervention Description
the ankle of children will be mobilized for 5 minutes (first two weeks) to 10 minutes (last two weeks).
Primary Outcome Measure Information:
Title
slope of the torque-angle curve
Description
Analysis of the slope of the torque-angle curve in Nm/°. It is measured by isokinetic dynamometer with ultrasound.
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Maximal dorsiflexion angle
Description
Analysis of the maximal dorsiflexion angle in degrees. It is measured by isokinetic dynamometer with ultrasound.
Time Frame
up to 12 weeks
Title
Slope of the torque- MyoTendinous Junction (MTJ) displacement
Description
Analysis of the Slope of the torque- MyoTendinous Junction (MTJ) displacement in cm/°. It is measured by isokinetic dynamometer with ultrasound.
Time Frame
up to 12 weeks
Title
MyoTendinous Junction (MTJ) displacement of muscle triceps sural
Description
Analysis of the MyoTendinous Junction (MTJ) displacement of muscle triceps sural in cm. It is measured by isokinetic dynamometer with ultrasound.
Time Frame
up to 12 weeks
Title
muscle triceps sural, muscle body of the medial gastrocnemius muscle and Achilles tendon
Description
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.
Time Frame
up to 12 weeks
Title
discomfort level
Description
Analysis of the discomfort level. It is measured by Visual Analog Scale (VAS) completed by children. 0 = no discomfort and 10 = maximum discomfort
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent GAUTHERON, PhD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Étienne
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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