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TerminatedNCT02550509Updated Sep 20, 2016

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

An interventional study of ultrasound echogenicity and elastography in Stroke, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-09-20.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Basic science

Why this study was terminated
Difficulties to include patients
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke

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Keywords

  • stroke
  • Botulinum toxin
  • Muscle alterations
03

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 6 is below the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • 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 · Device: elastography

Interventions

  • Deviceultrasound echogenicity

    ultrasound echogenicity to patient with stroke

  • Deviceelastography

    elastography to patient with stoke

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: from baseline to 1 year

07

Study locations

1 site
  • CHU Saint-Etienne
    Saint-Etienne, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2013, a primary completion of Jun 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2015
First posted
Sep 15, 2015
Start
Nov 2013
Primary completionActual
Jun 2016
CompletionActual
Jun 2016
Last update
Sep 20, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02550509
Responsible party
Sponsor
First posted
Sep 15, 2015
Start date
Nov 2013
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Sep 20, 2016

Study contacts

PAul Calmels, MD
principal investigator · Centre Hospitalier Universitaire de Saint Etienne

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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