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

NCT06956326 | Recruiting Phase 2

• 1 other identifier: MS_Early_Rehab
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis

Keywords

Neurorehabilitation

Outcome Measures

Primary Outcomes (2)

• Expanded Disability Status Scale (EDSS)

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

  Change from Baseline to 52 weeks

• MS Functional Composite (MSFC) Score

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

  Change from Baseline to 52 weeks

Secondary Outcomes (13)

• MS Functional Composite (MSFC) Score

  Changes from Baseline to 2 weeks and 10 weeks

• Handgrip strength

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

• Six spot step test (SSST)

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

• 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

Study Arms (2)

Intensive rehab

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

10 weeks of usual care physiotherapy, normally comprised of municipal rehabilitation as well as self-administered behavior.

Behavioral: Usual care

Interventions

Intensive rehab BEHAVIORAL

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

Intensive rehab

Usual care BEHAVIORAL

Usual care physiotherapy

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lars Hvid: lead

Study Sites (2)

The Danish MS Hospitals

Haslev, 7080, Denmark

RECRUITING

The Danish MS Hospitals

Ry, 7080, Denmark

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Lars Hvid, PhD

CONTACT

+4593508717; larshv@sclerosehospital.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Researcher, PhD

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 4, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)