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NCT Number: NCT06956326

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

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.

Recruiting

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Danish MS Hospitals, Haslev, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive rehab

Behavioral

Frequent moderate-to-high intensity physical therapy, provided by local physiotherapists.

Usual Care

Behavioral

Usual care physiotherapy

Primary outcomes

  1. Expanded Disability Status Scale (EDSS)

    Time frame: Change from Baseline to 52 weeks

    The Expanded Disability Status Scale measures your current level of disability.

  2. MS Functional Composite (MSFC) Score

    Time frame: Change from Baseline to 52 weeks

    A standardized tool used to quantify the degree of disability in patients with multiple sclerosis (MS).

Secondary outcomes

  1. MS Functional Composite (MSFC) Score

    Time frame: Changes from Baseline to 2 weeks and 10 weeks

    A standardized tool used to quantify the degree of disability in patients with multiple sclerosis (MS).

  2. Handgrip strength

    Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    Maximal handgrip muscle strength of both sides.

  3. Six spot step test (SSST)

    Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    Measure of walking balance and coordination

  4. Five times sit to stand chair rise test (5STS)

    Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    Measure of lower extremity function

  5. 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

    Measure of lower extremity muscle power

  6. Patient determined disease steps (PDDS)

    Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    Patient-reported measure of mobility disability.

  7. MS Walking Scale (MSWS)

    Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    Patient-reported measure of walking ability.

  8. Falls Efficacy Scale International (short FES-I)

    Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    Patient-reported measure of concerns of falls (including history of falls).

  9. Functional Assessment of MS (FAMS)

    Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    Patient-reported measure of how MS impacts quality of life.

  10. Modified Fatigue Impact Scale (MFIS)

    Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    Patient-reported measure of fatigue.

  11. Manual Ability Measurement (MAM36)

    Time frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks

    Patient-reported measure of hand function related to functional questions.

  12. Treatment Satisfactory Questionnaire (TSQ)

    Time frame: Evaluated at 2 weeks, 10 weeks, and 52 weeks

    Patient-reported measure of treatment satisfaction.

  13. Multiple Sclerosis Cognitive Scale (MSCS)

    Time frame: Changes from baseline to 2 weeks, 10 weeks, and 52 weeks

    Patient-reported measure of cognitive function.

Study contacts

Contact information is provided by the study sponsor or research team.

Lars Hvid, PhD

CONTACT

[email protected]

+4593508717

Sponsors and collaborators

Lead sponsor

Lars Hvid

Other

Registry information

Acronym: MS_Early_Rehab

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 4, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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