Changes in Echogenicity and Muscle Stiffness in Elastography After Botulinum Toxin Injection a Spastic Muscle

Not Applicable

Terminated

• Conditions: Stroke
• Interventions: Device: ultrasound echogenicity; Device: elastography

• Registration Number: NCT02550509
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Muscle alterations and modifications passive biomechanical properties that occur on a spastic muscle contribute to functional disorders involved in spasticity. Botulinum toxin (TB) A is the reference treatment of the focused spasticity, and muscle source structural and biomechanical changes, very little studied in humans, especially since it is not one possibility of easily and reliably paraclinical assessment injections consequences.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2015-09-14
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-15
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• A first stroke older than nine months (acute phase and subacute stroke).
• Hemiplegia cerebral vascular following this stroke.
• Hemiplegia with an overall motor deficit plegic lower limb muscle testing level less than or equal to 3 and associating a localized spasticity lower plegic member, on the plantar flexors, assessed by the upper Ashworth Scale or equal to 1 with an injection of botulinum toxin indication of the sural triceps.
• written consent.

Exclusion Criteria

• Old stroke with motor impairment of the lower limb in the chronic stage.
• Concomitant muscle disease (eg myopathy, myositis ...).
• Patients who already received a botulinum toxin injection into the gastrocnemius muscles.
• Subjects with defibrillator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with hemiplegia after stroke	elastography	ultrasound echogenicity paraclinical assessment and elastography to patients with hemiplegia following stroke with an indication of injection of botulinum toxin into the triceps sural
patients with hemiplegia after stroke	ultrasound echogenicity	ultrasound echogenicity paraclinical assessment and elastography to patients with hemiplegia following stroke with an indication of injection of botulinum toxin into the triceps sural

Primary Outcome Measures

Name	Time	Method
Change in muscular trophism	from baseline to 1 year	Change in muscular trophism treated by botulinum toxin. Muscular trophism determined by a combined endpoint assessment of muscular echogenicity following scale Heckmatt I to IV, the measurement of the thickness in mm and angle pennation fascicular of medial and lateral gastrocnemius muscles to measured with an ultrasound scanner

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Etienne, France