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CompletedNCT02549807Updated Sep 15, 2015

Measurement by 2D Ultrasound of the Pennation Angle and Elasticity of Gastrocnemius Muscle

An observational study in Hemiplegia, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 5 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-09-15.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
5 Years to 75 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Hemiplegia

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Keywords

  • Vascular hemiplegia
  • 2D ultrasound
  • Muscle elasticity
  • Pennation angle
03

In context

Hemiplegia

374 studies on the registry are indexed under Hemiplegia; 83 are open to participants now.

This study's enrollment of 30 is below the median of 51 across 56 observational studies indexed under Hemiplegia.

Browse Hemiplegia studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hemiplegic adults/children/adolescent after stroke ,

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

    Device: Muscle elasticity measure

  • 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)

    Device: Muscle elasticity measure

  • 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)

    Device: Muscle elasticity measure

Interventions

  • DeviceMuscle 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.

06

What researchers measure

Primary outcomes

  1. Pennation angle

    Pennation angle of the medial gastrocnemius muscle measuring in degrees in a sagittal section by 2D ultrasound.

    Time frame: Day 1

Secondary outcomes

  1. Muscle Elasticity

    Measurement of elastic modulus (kPa) of anterior gastrocnemius muscles, on a sagittal section by sonoelastometry ShearWave ™.

    Time frame: Day 1

07

Study locations

1 site
  • CHU de SAINT-ETIENNE
    Saint-etienne, 42000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02549807
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Sep 15, 2015
Start date
Jul 2014
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Sep 15, 2015

Study contacts

Vincent GAUTHERON, MD PhD
principal investigator · CHU de SAINT-ETIENNE

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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