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

Stroke Clinical Trial

Official title:

Changes in Echogenicity and Muscle Stiffness in Elastography After Botulinum Toxin Injection a Spastic Muscle - A Monocentric Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02550509
• Other study ID #: 1301141
• Status: Terminated
• Phase: N/A
• First received: September 14, 2015
• Last updated: September 19, 2016
• Start date: November 2013
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke

Intervention

Device:
• ultrasound echogenicity
ultrasound echogenicity to patient with stroke
• elastography
elastography to patient with stoke

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No