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

Multiple Sclerosis Clinical Trial

— GAITOX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265092
• Other study ID #: Pole-sthelier
• Status: Completed
• Start date: January 2014
• Est. completion date: January 2019

Study information

• Verified date: November 2019
• Source: Pôle Saint Hélier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2019
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Muscle Spasticity
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pôle Saint Hélier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spatiotemporal gait parameters	Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)	at inclusion
Primary	Spatiotemporal gait parameters	Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)	at inclusion
Primary	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
Primary	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
Primary	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
Primary	Spatiotemporal gait parameters	Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).	at inclusion
Primary	Spatiotemporal gait parameters	Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)	At six weeks
Primary	Spatiotemporal gait parameters	Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)	At six weeks
Primary	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
Primary	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
Primary	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
Primary	Spatiotemporal gait parameters	Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).	At six weeks
Primary	Spatiotemporal gait parameters	Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)	At three months
Primary	Spatiotemporal gait parameters	Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)	At three months
Primary	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
Primary	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
Primary	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
Primary	Spatiotemporal gait parameters	Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).	At three months
Secondary	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
Secondary	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
Secondary	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
Secondary	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