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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02550509
Enrollment
6
Registered
2015-09-15
Start date
2013-11-30
Completion date
2016-06-30
Last updated
2016-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, Botulinum toxin, Muscle alterations

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.

Interventions

DEVICEultrasound echogenicity

ultrasound echogenicity to patient with stroke

DEVICEelastography

elastography to patient with stoke

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in muscular trophismfrom baseline to 1 yearChange 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026