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

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT04265092
• Lead Sponsor: Pôle Saint Hélier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-03
• Study Completion: 2019-01
• Study First Submitted: 2019-10-22
• Status Verified: 2019-11
• Study First Submitted QC: 2020-02-10
• Last Update Submitted: 2020-02-10
• Study First Posted: 2020-02-11
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spatiotemporal gait parameters	At three months	Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).

Secondary Outcome Measures

Name	Time	Method
the Goal Attainment Scale (GAS) score with determination	at inclusion, at 6 weeks, at three months	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
Six-Minute Walk Test (6MWT)	at inclusion, at 6 weeks, at three months	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.
the Multiple Sclerosis Walking Scale (MSWS-12)	at inclusion, at 6 weeks, at three months	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.
The Timed Up and Go test (TUG)	at inclusion, at 6 weeks, at three months	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.