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

NCT02550509 | Terminated

• 1 other identifier: 1301141
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; Botulinum toxin; Muscle alterations

Outcome Measures

Primary Outcomes (1)

• Change in muscular trophism

  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

  from baseline to 1 year

Study Arms (1)

patients with hemiplegia after stroke

EXPERIMENTAL

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

Device: ultrasound echogenicity; Device: elastography

Interventions

ultrasound echogenicity DEVICE

ultrasound echogenicity to patient with stroke

patients with hemiplegia after stroke

elastography DEVICE

elastography to patient with stoke

patients with hemiplegia after stroke

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Stroke

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• PAul Calmels, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 15, 2015
• Study Start: November 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

FR (1)