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Clinical Trials/NCT02550509
NCT02550509
Terminated
Not Applicable

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country6 target enrollmentNovember 2013
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
6
Locations
1
Primary Endpoint
Change in muscular trophism
Status
Terminated
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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