Clinical trial NCT04265092: Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis
Official title: Gaitox :Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis an Observational Study on Gait Spatiotemporal Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Gait
Multiple Sclerosis
Spasticity
Toxin
Triceps surae
Lead sponsor: Pôle Saint Hélier
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty-two MS patients with a mean age of 48.2 +/- 12 years were enrolled in this study, 15 women and 7 men. In 13 patients, the disease had been in a relapsing-remitting mode for 15.2 +/- 12 years, 4 patients had secondary-progressive disease and 5 had primary progressive disease, with a mean EDSS of 4.2 +/- 1.5. Triceps surae spasticity on the Modified Ashworth Scale was 2.4 +/- 0.7.

Brief summary: Introduction/Objectives: In this observational study, we assessed the benefit following an injection of 200 international units (IU) of incobotulinum toxinA in patients with multiple sclerosis (MS) with spasticity of the triceps surae (TS) at 6 weeks (peak efficacy of toxin) and at 3 months (cancellation of efficacy).

Methods: This study enrolled all MS patients willing to participate with Expanded Disability Status Scale (EDSS) scores of less than 6, who required toxin for management of focal spasticity of the TS. Treatment consisted of 200 IU of incobotulinum toxinA injected into the TS. Outcome measures were assessed before injection, at 6 weeks and 3 months post-injection, using the Goal Attainment Scale (GAS), Twelve Item MS Walking (MSWS-12) Scale, Timed Up and Go (TUG) Test, 6 Minute Walk Test (6MWT). Spatiotemporal gait data was obtained by GAITRite.


Eligibility criteria: Inclusion Criteria:

* MS patients aged over 18 years
* with gait problems related to spasticity of the triceps surae,
* walking 10 m in less than a minute,
* with or without technical assistance,
* with an EDSS of 6.5 or less
* triceps surae spasticity of between 1 and 3 on the Modified Ashworth Scale.

Exclusion Criteria:

* Comprehension problems preventing the patient from expressing his/her free and informed consent to the study.
* Intolerance to botulinum toxin;
* botulinum toxin injection in the previous three months.

Primary outcomes:
measure: Spatiotemporal gait parameters
timeFrame: at inclusion
measure: Spatiotemporal gait parameters
timeFrame: at inclusion
measure: Spatiotemporal gait parameters
timeFrame: at inclusion
measure: Spatiotemporal gait parameters
timeFrame: at inclusion
measure: Spatiotemporal gait parameters
timeFrame: at inclusion
measure: Spatiotemporal gait parameters
timeFrame: at inclusion
measure: Spatiotemporal gait parameters
timeFrame: At six weeks
measure: Spatiotemporal gait parameters
timeFrame: At six weeks
measure: Spatiotemporal gait parameters
timeFrame: At six weeks
measure: Spatiotemporal gait parameters
timeFrame: At six weeks
measure: Spatiotemporal gait parameters
timeFrame: At six weeks
measure: Spatiotemporal gait parameters
timeFrame: At six weeks
measure: Spatiotemporal gait parameters
timeFrame: At three months
measure: Spatiotemporal gait parameters
timeFrame: At three months
measure: Spatiotemporal gait parameters
timeFrame: At three months
measure: Spatiotemporal gait parameters
timeFrame: At three months
measure: Spatiotemporal gait parameters
timeFrame: At three months
measure: Spatiotemporal gait parameters
timeFrame: At three months
Secondary outcomes:
measure: Six-Minute Walk Test (6MWT)
timeFrame: at inclusion, at 6 weeks, at three months
measure: the Multiple Sclerosis Walking Scale (MSWS-12)
timeFrame: at inclusion, at 6 weeks, at three months
measure: the Goal Attainment Scale (GAS) score with determination
timeFrame: at inclusion, at 6 weeks, at three months
measure: The Timed Up and Go test (TUG)
timeFrame: at inclusion, at 6 weeks, at three months
Other outcomes:
Locations:
Study officials:
References: