GAITOX
What it found
We found no results in the registry or in papers.
This trial finished 12 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Onabotulinumtoxina
Synaptosomal nerve-associated protein 25 (SNAP-25) inhibitor
What it measured
Main measures
Spatiotemporal gait parameters
at inclusion
Walking and mobilitySpatiotemporal gait parameters
At six weeks
Walking and mobilitySpatiotemporal gait parameters
At three months
Walking and mobility
Other measures (4)
Six-Minute Walk Test (6MWT)
at inclusion, at 6 weeks, at three months
Walking and mobilitythe Multiple Sclerosis Walking Scale (MSWS-12)
at inclusion, at 6 weeks, at three months
Walking and mobilitythe Goal Attainment Scale (GAS) score with determination
at inclusion, at 6 weeks, at three months
The Timed Up and Go test (TUG)
at inclusion, at 6 weeks, at three months
Walking and mobility
Who could take part
MS (type not specified) · 18 and over
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Jan 2014
Main results due
Mar 2014
Finished
Jan 2019
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