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

NCT ID: NCT06956326

Last Updated: 2025-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Intensive rehab

Intervention Type BEHAVIORAL

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

Usual care

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Usual care physiotherapy

Interventions

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Intensive rehab

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

Intervention Type BEHAVIORAL

Usual care

Usual care physiotherapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lars Hvid

OTHER

Sponsor Role lead

Responsible Party

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Lars Hvid

Senior Researcher, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The Danish MS Hospitals

Haslev, , Denmark

Site Status RECRUITING

The Danish MS Hospitals

Ry, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Lars Hvid, PhD

Role: CONTACT

+4593508717

Facility Contacts

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Lars Hvid, PhD

Role: primary

+4593508717

Lars Hvid, PhD

Role: primary

+4593508717

Other Identifiers

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MS_Early_Rehab

Identifier Type: -

Identifier Source: org_study_id

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