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

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ClinicalTrials.gov Identifier: NCT03714269
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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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).

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: measurement evaluated with an isokinetic dynamometer Other: measurement evaluated with an 2D ultrasound Other: assessment of the level of discomfort Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Acute Effects of a Passive Stretching Session on the Mechanical Properties of Medial Gastrocnemius Muscle in Children With Cerebral Palsy
Actual Study Start Date : October 19, 2018
Actual Primary Completion Date : November 28, 2018
Actual Study Completion Date : November 28, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Children with cerebral palsy of the spastic type Other: measurement evaluated with an isokinetic dynamometer
measurement of the maximum dorsiflexion angle in degrees evaluated on an isokinetic dynamometer

Other: measurement evaluated with an 2D ultrasound
  • 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.

Other: assessment of the level of discomfort
visual analogue scale (0 = no discomfort and 10 = maximal discomfort)


Outcome Measures
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Primary Outcome Measures :
  1. slope of the torque curve force-ankle joint angle in the joint area -25° plantar flexion/maximum dorsal flexion [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. Maximum dorsal flexion angle of ankle, knee in maximum extension position [ Time Frame: at 5 minutes ]
  2. 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 ]
  3. 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 ]
  4. visual analogue scale of discomfort [ Time Frame: at 5 minutes ]
    0 = not discomfort and 10 = maximal discomfort


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714269


Locations
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France
CHU de Saint Etienne
Saint Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Vincent GAUTHERON CHU de Saint Etienne
More Information
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03714269    
Other Study ID Numbers: 18CH121
ANSM ( Other Identifier: 2018-A01921-54 )
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
children
medial gastrocnemius muscle
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases