Back to resultsChanges in Echogenicity and Muscle Stiffness in Elastography After Botulinum Toxin Injection a Spastic Muscle
Primary Purpose
Stroke
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ultrasound echogenicity
elastography
Sponsored by
About this trial
This is an interventional basic science trial for Stroke focused on measuring stroke, Botulinum toxin, Muscle alterations
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
Sites / Locations
- CHU Saint-Etienne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients with hemiplegia after stroke
Arm Description
ultrasound echogenicity paraclinical assessment and elastography to patients with hemiplegia following stroke with an indication of injection of botulinum toxin into the triceps sural
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02550509
First Posted
September 14, 2015
Last Updated
September 19, 2016
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT02550509
Brief Title
Changes in Echogenicity and Muscle Stiffness in Elastography After Botulinum Toxin Injection a Spastic Muscle
Official Title
Changes in Echogenicity and Muscle Stiffness in Elastography After Botulinum Toxin Injection a Spastic Muscle - A Monocentric Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Difficulties to include patients
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, Botulinum toxin, Muscle alterations
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with hemiplegia after stroke
Arm Type
Experimental
Arm Description
ultrasound echogenicity paraclinical assessment and elastography to patients with hemiplegia following stroke with an indication of injection of botulinum toxin into the triceps sural
Intervention Type
Device
Intervention Name(s)
ultrasound echogenicity
Intervention Description
ultrasound echogenicity to patient with stroke
Intervention Type
Device
Intervention Name(s)
elastography
Intervention Description
elastography to patient with stoke
Primary Outcome Measure Information:
Title
Change in muscular trophism
Description
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
Time Frame
from baseline to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PAul Calmels, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Etienne
Country
France
12. IPD Sharing Statement
Learn more about this trial
Changes in Echogenicity and Muscle Stiffness in Elastography After Botulinum Toxin Injection a Spastic Muscle
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