Clinical trial NCT06956326: Illuminating New Paths in the Treatment of Multiple Sclerosis Relapses - Early and Specialized Rehabilitation
Official title: Illuminating New Paths in the Treatment of Multiple Sclerosis Relapses - Early and Specialized Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Neurorehabilitation
Lead sponsor: Danish Multiple Sclerosis Hospitals
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Change from Baseline to 52 weeks
measure: MS Functional Composite (MSFC) Score
timeFrame: Change from Baseline to 52 weeks
Secondary outcomes:
measure: MS Functional Composite (MSFC) Score
timeFrame: Changes from Baseline to 2 weeks and 10 weeks
measure: Handgrip strength
timeFrame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
measure: Six spot step test (SSST)
timeFrame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
measure: Five times sit to stand chair rise test (5STS)
timeFrame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
measure: Five times sit to stand chair rise test muscle power (5STS_power)
timeFrame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
measure: Patient determined disease steps (PDDS)
timeFrame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
measure: MS Walking Scale (MSWS)
timeFrame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
measure: Falls Efficacy Scale International (short FES-I)
timeFrame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
measure: Functional Assessment of MS (FAMS)
timeFrame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
measure: Manual Ability Measurement (MAM36)
timeFrame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
measure: Treatment Satisfactory Questionnaire (TSQ)
timeFrame: Evaluated at 2 weeks, 10 weeks, and 52 weeks
measure: Multiple Sclerosis Cognitive Scale (MSCS)
timeFrame: Changes from baseline to 2 weeks, 10 weeks, and 52 weeks
Other outcomes:
Locations:
city: Haslev
country: Denmark
facility: The Danish MS Hospitals
city: Ry
country: Denmark
facility: The Danish MS Hospitals
Study officials:
References: