An observational study in Multiple Sclerosis, sponsored by Pôle Saint Hélier. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Pôle Saint Hélier · Observational
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.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's enrollment of 22 is below the median of 60 across 162 observational studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Pôle Saint Hélier is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
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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.
Exclusion Criteria:
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.
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)
Time frame: at inclusion
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: at inclusion
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).
Time frame: at inclusion
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)
Time frame: At six weeks
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: At six weeks
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).
Time frame: At six weeks
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: gait velocity (m/sec)
Time frame: At three months
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: cadence (nb/sec)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: At three months
Spatiotemporal gait parameters
Measurement of temporospatial gait parameters by GAITRite® Portable Gait Analysis Walkway: support distribution (in %).
Time frame: At three months
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: at inclusion, at 6 weeks, at three months
No study locations are listed for this record.
Plan to share: No — This prospective study is an observational pilot study, which seeks to evaluate the impact of a common treatment, as administered on a daily basis, without any change in the patients usual treatment pathway.
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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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