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

May 1, 2025 updated by: Lars Hvid
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive rehab

10 weeks of community-based physical therapy. Participants will receive two weekly supervised physical therapy session (45-60 minutes).

The content of this exercise program and the specific exercises and exercise methods will be planned in collaboration between MS specialists from the Danish MS hospitals, the local physical therapist, and the participant.
Behavioral: Intensive rehab
Frequent moderate-to-high intensity physical therapy, provided by local physiotherapists.
Active Comparator: Usual care
10 weeks of usual care physiotherapy, normally comprised of municipal rehabilitation as well as self-administered behavior.
Behavioral: Usual care
Usual care physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expanded Disability Status Scale (EDSS)
Time Frame: Change from Baseline to 52 weeks
The Expanded Disability Status Scale measures your current level of disability.
Change from Baseline to 52 weeks
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).
Change from Baseline to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Changes from Baseline to 2 weeks and 10 weeks
Handgrip strength
Time Frame: Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks
Maximal handgrip muscle strength of both sides.
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
Measure of walking balance and coordination
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
Measure of lower extremity function
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
Measure of lower extremity muscle power
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
Patient-reported measure of mobility disability.
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
Patient-reported measure of walking ability.
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
Patient-reported measure of concerns of falls (including history of falls).
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
Patient-reported measure of how MS impacts quality of life.
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
Patient-reported measure of fatigue.
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
Patient-reported measure of hand function related to functional questions.
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
Patient-reported measure of treatment satisfaction.
Evaluated at 2 weeks, 10 weeks, and 52 weeks
Multiple Sclerosis Cognitive Scale (MSCS)
Time Frame: Changes from baseline to 2 weeks, 10 weeks, and 52 weeks
Patient-reported measure of cognitive function.
Changes from baseline to 2 weeks, 10 weeks, and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lars Hvid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 1, 2025

First Submitted That Met QC Criteria

May 1, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 4, 2025

Last Update Submitted That Met QC Criteria

May 1, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS_Early_Rehab

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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