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Acute Effects of a Passive Stretching Session on the Mechanical Properties of Medial Gastrocnemius Muscle in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
measurement evaluated with an isokinetic dynamometer
measurement evaluated with an 2D ultrasound
assessment of the level of discomfort
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebral Palsy focused on measuring children, medial gastrocnemius muscle

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • CHU de Saint Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children with cerebral palsy of the spastic type

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maximum dorsal flexion angle of ankle, knee in maximum extension position
slope of the force-displacement torque curve myotendinous junction of the Sural Triceps in the articular sector -25° plantar flexion/maximum dorsal flexion
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.
visual analogue scale of discomfort
0 = not discomfort and 10 = maximal discomfort

Full Information

First Posted
October 18, 2018
Last Updated
May 28, 2019
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT03714269
Brief Title
Acute Effects of a Passive Stretching Session on the Mechanical Properties of Medial Gastrocnemius Muscle in Children With Cerebral Palsy
Official Title
Acute Effects of a Passive Stretching Session on the Mechanical Properties of Medial Gastrocnemius Muscle in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 19, 2018 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
November 28, 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
children, medial gastrocnemius muscle

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children with cerebral palsy of the spastic type
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
measurement evaluated with an isokinetic dynamometer
Intervention Description
measurement of the maximum dorsiflexion angle in degrees evaluated on an isokinetic dynamometer
Intervention Type
Other
Intervention Name(s)
measurement evaluated with an 2D ultrasound
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
assessment of the level of discomfort
Intervention Description
visual analogue scale (0 = no discomfort and 10 = maximal discomfort)
Primary Outcome Measure Information:
Title
slope of the torque curve force-ankle joint angle in the joint area -25° plantar flexion/maximum dorsal flexion
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Maximum dorsal flexion angle of ankle, knee in maximum extension position
Time Frame
at 5 minutes
Title
slope of the force-displacement torque curve myotendinous junction of the Sural Triceps in the articular sector -25° plantar flexion/maximum dorsal flexion
Time Frame
at 5 minutes
Title
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.
Time Frame
at 5 minutes
Title
visual analogue scale of discomfort
Description
0 = not discomfort and 10 = maximal discomfort
Time Frame
at 5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with cerebral palsy of the spastic type Children with a maximum dorsal ankle flexion amplitude limitation of less than 10°. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent GAUTHERON
Organizational Affiliation
CHU de Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36318307
Citation
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.
Results Reference
derived

Learn more about this trial

Acute Effects of a Passive Stretching Session on the Mechanical Properties of Medial Gastrocnemius Muscle in Children With Cerebral Palsy

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