- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02549807
Measurement by 2D Ultrasound of the Pennation Angle and Elasticity of Gastrocnemius Muscle
September 14, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne
Evaluation of the Reproducibility of the Measurement by 2D Ultrasound and Sonoelastometry of the Pennation Angle and Elasticity of the Medial Gastrocnemius Muscle in Children/Adolescent/Adult Cerebral Hemiplegia After Stroke
Hemiplegic adults after stroke (stroke), children and adolescents with cerebral palsy (CP) have both muscles spastic and paresis.
These movement disorders are likely to cause muscle changes both structural and viscoelastic involved in the alteration of neuromotor functions such as walking.
Therefore, it seems interesting to study the structure of these muscles with available imaging techniques.
The medial gastrocnemius muscle presents architectural characteristics which allows easy evaluation 2D ultrasound.
The literature lacks data on the reproducibility of the measurement, by 2D ultrasound, of the pennation angle and muscular thickness, particularly in children.
In addition, the sonoelastometry by Supersonic ShearWave Imaging (SSI) is a new technique of ultrasound, non-invasive, dynamic, which allows the calculation of the modulus of elasticity within a muscle tissue.
This allows to consider new perspectives evaluation of the viscoelastic properties of the muscle.
No studies have evaluated the reproducibility of this method in adults/children/ adolescent after stroke and hemiplegia.
Study Overview
Detailed Description
A 1 week apart, an ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back.
The thickness, elasticity and the pennation angle of the medial gastrocnemius muscle will be measured.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Saint-etienne, France, 42000
- CHU de Saint-Etienne
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Hemiplegic adults/children/adolescent after stroke ,
Description
Inclusion Criteria:
Children
- Cerebral Paralyzed, with an infantile cerebral hemiplegia, spastic type with a level of functional independence of walking I or II of the GMFCS level.
- Having a level of spasticity in gastrocnemius muscles of the lower member plegic higher or equal to X1, V 2, on the scale of Tardieu.
- Boys aged 5 to 12 years and girls aged 5 to 11 years.
Adolescent
- Cerebral Paralyzed, with an infantile cerebral hemiplegia, spastic type with a level of functional independence of walking I or II of the GMFCS level.
- Having a level of spasticity in gastrocnemius muscles of the lower member plegic higher or equal to X1, V 2, on the scale of Tardieu.
- Boys aged 11-18 years and girls aged 10-18 years.
Adult
- Aged 18 to 75, of both sexes. - Having suffered a stroke (stroke) regardless of the date of the stroke. - Presenting hemiplegia cerebral vascular following the stroke.
- walking, with or without technical assistance or device (splint, cane ...)
- Presenting a focused plegic spasticity in the lower limb, the plantar flexors, assessed by Tardieu scale and higher than or equal to X1, V2.
Exclusion Criteria:
Children and adolescent
- Having received botulinum toxin injections in the gastrocnemius muscle in the three months preceding the assessment.
- Having received lengthening plasters in the three months preceding the assessment.
- Having benefited from therapeutic to target muscle (baclofen, a muscle relaxant ...) the beginning of the treatment would have started in the months preceding the assessment.
- Having enjoyed orthopedic surgery at the muscular structures, tendons and bone of the leg plegic.
Adult
- Presenting a concomitant muscle disease (eg myopathy, myositis ...).
- Having received injections of botulinum toxin in the gastrocnemius muscle in the three months preceding the assessment.
- Having benefited from therapeutic to target muscle (baclofen, a muscle relaxant ...) the beginning of the treatment would have started in the months preceding the assessment.
- Having enjoyed orthopedic or neurological surgery at the plegic lower limb.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children muscle elasticity measure
an ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back.
The thickness, elasticity and the angle of the medial gastrocnemius muscle pennation will be measured (muscle elasticity measure)
|
an ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back.
The thickness, elasticity and the angle of the medial gastrocnemius muscle pennation will be measured.
|
|
Adolescent muscle elasticity measure
an ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back.
The thickness, elasticity and the angle of the medial gastrocnemius muscle pennation will be measured ((muscle elasticity measure)
|
an ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back.
The thickness, elasticity and the angle of the medial gastrocnemius muscle pennation will be measured.
|
|
Adult muscle elasticity measure
an ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back.
The thickness, elasticity and the angle of the medial gastrocnemius muscle pennation will be measured (muscle elasticity measure)
|
an ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back.
The thickness, elasticity and the angle of the medial gastrocnemius muscle pennation will be measured.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pennation angle
Time Frame: Day 1
|
Pennation angle of the medial gastrocnemius muscle measuring in degrees in a sagittal section by 2D ultrasound.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Elasticity
Time Frame: Day 1
|
Measurement of elastic modulus (kPa) of anterior gastrocnemius muscles, on a sagittal section by sonoelastometry ShearWave ™.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Vincent GAUTHERON, MD PhD, CHU de Saint-Etienne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
September 11, 2015
First Submitted That Met QC Criteria
September 14, 2015
First Posted (Estimate)
September 15, 2015
Study Record Updates
Last Update Posted (Estimate)
September 15, 2015
Last Update Submitted That Met QC Criteria
September 14, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1408031
- 2014-A00452-45 (Other Identifier: ANSM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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