NCT03714269

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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

October 19, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2018

Completed
Last Updated

May 30, 2019

Status Verified

October 1, 2018

Enrollment Period

1 month

First QC Date

October 18, 2018

Last Update Submit

May 28, 2019

Conditions

Cerebral Palsy

Keywords

childrenmedial gastrocnemius muscle

Outcome Measures

Primary Outcomes (1)

  • slope of the torque curve force-ankle joint angle in the joint area -25° plantar flexion/maximum dorsal flexion

    baseline

Secondary Outcomes (4)

  • Maximum dorsal flexion angle of ankle, knee in maximum extension position

    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

    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.

    at 5 minutes

  • visual analogue scale of discomfort

    at 5 minutes

Study Arms (1)

Children with cerebral palsy of the spastic type

EXPERIMENTAL
Other: measurement evaluated with an isokinetic dynamometerOther: measurement evaluated with an 2D ultrasoundOther: assessment of the level of discomfort

Interventions

measurement evaluated with an isokinetic dynamometerOTHER

measurement of the maximum dorsiflexion angle in degrees evaluated on an isokinetic dynamometer

Children with cerebral palsy of the spastic type
measurement evaluated with an 2D ultrasoundOTHER

* 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.

Children with cerebral palsy of the spastic type
assessment of the level of discomfortOTHER

visual analogue scale (0 = no discomfort and 10 = maximal discomfort)

Children with cerebral palsy of the spastic type

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

Related Publications (1)

  • Boulard C, Gautheron V, Lapole T. Acute passive stretching has no effect on gastrocnemius medialis stiffness in children with unilateral cerebral palsy. Eur J Appl Physiol. 2023 Mar;123(3):467-477. doi: 10.1007/s00421-022-05046-7. Epub 2022 Nov 1.

    PMID: 36318307DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Vincent GAUTHERON

    CHU de Saint Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2018

First Posted

October 22, 2018

Study Start

October 19, 2018

Primary Completion

November 28, 2018

Study Completion

November 28, 2018

Last Updated

May 30, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)