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

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ClinicalTrials.gov Identifier: NCT02550509
Recruitment Status : Terminated (Difficulties to include patients)
First Posted : September 15, 2015
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke Device: ultrasound echogenicity Device: elastography Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Changes in Echogenicity and Muscle Stiffness in Elastography After Botulinum Toxin Injection a Spastic Muscle - A Monocentric Study
Study Start Date : November 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: 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
Device: ultrasound echogenicity
ultrasound echogenicity to patient with stroke

Device: elastography
elastography to patient with stoke




Primary Outcome Measures :
  1. Change in muscular trophism [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550509


Locations
France
CHU Saint-Etienne
Saint-Etienne, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: PAul Calmels, MD CHU SAINT-ETIENNE

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02550509     History of Changes
Other Study ID Numbers: 1301141
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
stroke
Botulinum toxin
Muscle alterations

Additional relevant MeSH terms:
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs