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

NCT ID: NCT02550509

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

patients with hemiplegia after stroke

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

Group Type: EXPERIMENTAL

ultrasound echogenicity

Intervention Type: DEVICE

ultrasound echogenicity to patient with stroke

elastography

Intervention Type: DEVICE

elastography to patient with stoke

Interventions

ultrasound echogenicity

ultrasound echogenicity to patient with stroke

Intervention Type: DEVICE

elastography

elastography to patient with stoke

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

PAul Calmels, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

CHU Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

1301141

Identifier Type: -

Identifier Source: org_study_id