Illuminating New Paths in the Treatment of Multiple Sclerosis Relapses - Early and Specialized Rehabilitation
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT06956326
- Lead Sponsor
- Lars Hvid
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Expanded Disability Status Scale (EDSS) Change from Baseline to 52 weeks The Expanded Disability Status Scale measures your current level of disability.
MS Functional Composite (MSFC) Score Change from Baseline to 52 weeks A standardized tool used to quantify the degree of disability in patients with multiple sclerosis (MS).
- Secondary Outcome Measures
Name Time Method Falls Efficacy Scale International (short FES-I) Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks Patient-reported measure of concerns of falls (including history of falls).
Functional Assessment of MS (FAMS) Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks Patient-reported measure of how MS impacts quality of life.
Manual Ability Measurement (MAM36) Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks Patient-reported measure of hand function related to functional questions.
Modified Fatigue Impact Scale (MFIS) Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks Patient-reported measure of fatigue.
Multiple Sclerosis Cognitive Scale (MSCS) Changes from baseline to 2 weeks, 10 weeks, and 52 weeks Patient-reported measure of cognitive function.
Treatment Satisfactory Questionnaire (TSQ) Evaluated at 2 weeks, 10 weeks, and 52 weeks Patient-reported measure of treatment satisfaction.
MS Functional Composite (MSFC) Score 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).
Handgrip strength Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks Maximal handgrip muscle strength of both sides.
Six spot step test (SSST) Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks Measure of walking balance and coordination
Five times sit to stand chair rise test (5STS) Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks Measure of lower extremity function
Five times sit to stand chair rise test muscle power (5STS_power) Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks Measure of lower extremity muscle power
Patient determined disease steps (PDDS) Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks Patient-reported measure of mobility disability.
MS Walking Scale (MSWS) Changes from Baseline to 2 weeks, 10 weeks, and 52 weeks Patient-reported measure of walking ability.
Trial Locations
- Locations (1)
The Danish MS Hospitals
🇩🇰Ry, Denmark