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NCT Number: NCT02549807

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

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.

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Key information

Conditions

Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Muscle elasticity measure

Device

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.

Primary outcomes

  1. Pennation angle

    Time frame: Day 1

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

Secondary outcomes

  1. Muscle Elasticity

    Time frame: Day 1

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 15, 2015
Registry last updated
Sep 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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