Therapeutic Benefit of Incobotulinum Toxin A for Spasticity of the Triceps Surae in Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Incobotulinum toxin A


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Incobotulinum toxin A|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec) | at inclusion | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec) | at inclusion | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of stance time on the injected and non-injected side (in sec) | at inclusion | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of swing time on the injected and non-injected side (in sec) | at inclusion | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: step length on the injected and non-injected side (in meters) | at inclusion | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %). | at inclusion | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec) | At six weeks | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec) | At six weeks | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of stance time on the injected and non-injected side (in sec) | At six weeks | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of swing time on the injected and non-injected side (in sec) | At six weeks | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: step length on the injected and non-injected side (in meters) | At six weeks | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %). | At six weeks | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec) | At three months | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec) | At three months | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of stance time on the injected and non-injected side (in sec) | At three months | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: duration of swing time on the injected and non-injected side (in sec) | At three months | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: step length on the injected and non-injected side (in meters) | At three months | 
| Spatiotemporal gait parameters | Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %). | At three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-Minute Walk Test (6MWT) | The 6 MWT is a simple test which requires a 30-meter course, calm, indoors, flat, in a rectilinear rectangular corridor. The route is marked every 3 meters with colored marks. The U-turn should be viewed with a cone. The purpose of this test is to walk as much as possible for 6 minutes. The score is between 0 meters for a non-ambulatory person and about 900 meters for a healthy subject. | at inclusion, at 6 weeks, at three months | 
| the Multiple Sclerosis Walking Scale (MSWS-12) | From the numbers circled against these questions, the healthcare professional can calculate the MSWS-12 score. This is done by adding the numbers you have circled, giving a total out of 60, and then transforming this to a scale with a range from 0 to 100. Higher scores indicate a greater impact on walking than lower scores. | at inclusion, at 6 weeks, at three months | 
| the Goal Attainment Scale (GAS) score with determination | In collaboration with the patient, the doctor define a primary and a secondary objectives, with a specific mark for each: -2: worse than before, -1: no change, 0: objective achieved, 1: result better than expected, 2: unexpected result | at inclusion, at 6 weeks, at three months | 
| The Timed Up and Go test (TUG) | TUG performance is rated on a scale of 1 to 5, where 1 indicates normal functioning and 5 indicates severe abnormal behavior, according to the individual's perception of the risk of falling (Podsiadlo & Richardson, 1991) . The score consists of the time taken to complete the test, in seconds. | at inclusion, at 6 weeks, at three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait, Multiple Sclerosis, Spasticity, Toxin, Triceps surae