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Recruiting NCT06956326

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

Phase II Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intensive rehab, Usual care.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral Intensive rehab
    Frequent moderate-to-high intensity physical therapy, provided by local physiotherapists.
  • Behavioral Usual care
    Usual care physiotherapy

Primary outcome measures

  • Expanded Disability Status Scale (EDSS) [Time frame: Change from Baseline to 52 weeks]
  • MS Functional Composite (MSFC) Score [Time frame: Change from Baseline to 52 weeks]
Secondary outcome measures (12)
  • MS Functional Composite (MSFC) Score [Time frame: Changes from Baseline to 2 weeks and 10 weeks]
  • Handgrip strength [Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks]
  • Six spot step test (SSST) [Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks]
  • Five times sit to stand chair rise test (5STS) [Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks]
  • Five times sit to stand chair rise test muscle power (5STS_power) [Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks]
  • Patient determined disease steps (PDDS) [Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks]
  • MS Walking Scale (MSWS) [Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks]
  • Falls Efficacy Scale International (short FES-I) [Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks]
  • Functional Assessment of MS (FAMS) [Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks]
  • Modified Fatigue Impact Scale (MFIS) [Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks]
  • Manual Ability Measurement (MAM36) [Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks]
  • Treatment Satisfactory Questionnaire (TSQ) [Time frame: Evaluated at 2 weeks, 10 weeks, and 52 weeks]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Denmark · 2 centers
  • The Danish MS Hospitals — Haslev
  • The Danish MS Hospitals — Ry

Identifiers

NCT: NCT06956326 · MS_Early_Rehab

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗