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

Children, Only Clinical Trial

— 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).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03565172
• Other study ID #: 18CH033
• Secondary ID: ID-RCB
• Status: Terminated
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: July 26, 2018

Study information

• Verified date: August 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 26, 2018
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Children, Only
• Paralysis

Intervention

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).

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 12 weeks
Secondary	Maximal dorsiflexion angle	Analysis of the maximal dorsiflexion angle in degrees. It is measured by isokinetic dynamometer with ultrasound.	up to 12 weeks
Secondary	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.	up to 12 weeks
Secondary	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.	up to 12 weeks
Secondary	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.	up to 12 weeks
Secondary	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	up to 12 weeks