CompletedMS (type not specified)NCT04265092

What it found

No result 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

What it measured

Main measures

  • Spatiotemporal gait parameters

    at inclusion

    Walking and mobility
  • Spatiotemporal gait parameters

    At six weeks

    Walking and mobility
  • Spatiotemporal 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 mobility
  • the Multiple Sclerosis Walking Scale (MSWS-12)

    at inclusion, at 6 weeks, at three months

    Walking and mobility
  • the 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

    1. Started

      Jan 2014

    2. Main results due

      Mar 2014

    3. Finished

      Jan 2019

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