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

NCT02549807 | Completed

• 2 other identifiers: 14080312014-A00452-45
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemiplegia

Keywords

Vascular hemiplegia; 2D ultrasound; Muscle elasticity; Pennation angle

Outcome Measures

Primary Outcomes (1)

• Pennation angle

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

  Day 1

Secondary Outcomes (1)

• Muscle Elasticity

  Day 1

Study Arms (3)

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

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.

Adolescent muscle elasticity measure; Adult muscle elasticity measure; Children muscle elasticity measure

Eligibility Criteria

• Age: 5 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hemiplegic adults/children/adolescent after stroke ,

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

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

Study Officials

• Vincent GAUTHERON, MD PhD

  CHU de SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: September 15, 2015
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 15, 2015

Record last verified: 2015-09

Locations

FR (1)