Illuminating New Paths in the Treatment of Multiple Sclerosis Relapses - Early and Specialized Rehabilitation

RecruitingPhase 2MS (type not specified)NCT06956326

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Intensive rehab

Compared with

  • Usual care

What it measured

Main measures

  • Expanded Disability Status Scale (EDSS)

    Change from Baseline to 52 weeks

    Disability progression
  • MS Functional Composite (MSFC) Score

    Change from Baseline to 52 weeks

    Disability progression

Other measures (13)

  • MS Functional Composite (MSFC) Score

    Changes from Baseline to 2 weeks and 10 weeks

    Disability progression
  • Handgrip strength

    Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    Arm and hand functionPhysical function
  • Six spot step test (SSST)

    Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    Walking and mobility
  • Five times sit to stand chair rise test (5STS)

    Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

  • Five times sit to stand chair rise test muscle power (5STS_power)

    Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    Physical function
  • Patient determined disease steps (PDDS)

    Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    Walking and mobilityQuality of life (reported by participants)
  • MS Walking Scale (MSWS)

    Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    Walking and mobilityQuality of life (reported by participants)
  • Falls Efficacy Scale International (short FES-I)

    Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    Walking and mobilityQuality of life (reported by participants)
  • Functional Assessment of MS (FAMS)

    Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    Quality of life (reported by participants)
  • Modified Fatigue Impact Scale (MFIS)

    Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    FatigueQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* admitted to the Danish MS Hospitals for an inpatient rehabilitation stay * confirmed motor relapse (within the past 6 months) by a neurologist, with disability/ functional interference characterized by change in pyramidal, and/or cerebellar functional scores of 2 or higher * completed steroid or other acute relapse treatment, if prescribed * age over 18 years

Exclusion criteria

* more than 6 months since onset of motor relapse * medical conditions or substantial cognitive impairments that hinder participation in the study (e.g. inability to perform or understand the intensive rehabilitation) * pregnancy

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

The overall purpose of this project is to develop and test an infrastructure that can ensure early and specialized rehabilitation for individuals with multiple sclerosis (MS) on their path to recovery from a relapse. If this project proves successful, it can therefore help optimize clinical practice and provide a significant contribution to the treatment of relapsing-remitting sclerosis.

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History

    1. Started

      May 2025

    2. Main results due

      Dec 2027

    3. Finished

      Dec 2027

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