Multidisciplinary Rehabilitation for MS-Related Functional Motor Disorder
This Phase 2/3 study is planned to enroll 192 adults with Multiple Sclerosis (MS) experiencing new or worsening symptoms. Participants will undergo an assessment to identify those with Functional Motor Disorder (FMD) associated with MS. A subgroup will be randomized to receive a targeted FMD-specific rehabilitation program, while others will receive conventional rehabilitation. Outcomes will be assessed after three months, but results are currently unavailable.
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Why it matters
This study aims to clarify the frequency of FMD-MS overlap and the potential benefits of a specialized rehabilitation approach, addressing a common clinical challenge in MS management.
What this does not prove
No results have been reported yet, and the study does not establish clinical outcomes or the efficacy of treatments. Future conclusions will rely on the study's findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 192 · basis not reported
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- No
- Research areas
- Rehabilitation, Other
Original sources
Supporting passages (15)
study phaseThis multicenter prospective study is conducted at two tertiary multiple sclerosis (MS) centers in Italy and uses a sequential design combining an observational diagnostic phase with a nested randomized rehabilitation trial.
study designPart B is a pilot, randomized, assessor-blinded, parallel-group, active-controlled trial.
subjectsA total of 192 adults with MS according to the 2017 revisions of the McDonald criteria and reporting new or worsening neurological symptoms within the previous 30 days will be enrolled at two tertiary MS centers in Italy.
sample sizeMisclassification may result in unnecessary investigations or anti-inflammatory treatment and may delay access to mechanism-specific rehabilitation.\n\nIn Part A, 192 consecutive adults with MS presenting with self-reported acute neurological symptom worsening within the previous 30 days will undergo a standardized, cross-sectional multidimensional assessment.
randomizedPart B is a pilot, randomized, assessor-blinded, parallel-group, active-controlled trial.
controlledThese 26 participants are included within the overall cohort of 192 participants and are not an additional study population.\n\nParticipants entering Part B will be randomized in a 1:1 ratio to either a targeted FMD-specific multidisciplinary rehabilitation programme or conventional MS rehabilitation.
peer reviewedNo results are posted.
regulatory approvalParticipants not entering Part B will complete the study after Part A.
research categoriesThe study addresses the clinical difficulty of distinguishing inflammatory MS relapse from functional motor symptoms in people with established MS.
interventionParticipants with confirmed FMD-MS overlap who meet the additional Part B eligibility criteria and are randomized to the experimental arm will receive five consecutive days of in-person FMD-specific multidisciplinary rehabilitation, approximately two hours per day.
comparatorThe active comparator will consist of conventional MS rehabilitation addressing mobility, strength, gait, balance, endurance, fatigue management, and functional independence, without protocolized FMD-specific techniques.\n\nPart B aims to assess the feasibility, safety, and preliminary efficacy of the FMD-specific rehabilitation programme compared with conventional MS rehabilitation.
primary endpoint"description": "The number and percentage of evaluable participants in Part A who are classified as having Functional Motor Disorder-Multiple Sclerosis overlap, also referred to in the protocol as functional pseudorelapse.
follow upOutcomes will be assessed at baseline, immediately after the five-day intervention, and at three months.
findingsTogether, the two study parts are designed to establish the clinical relevance of FMD-MS overlap and generate evidence needed to plan a larger definitive rehabilitation trial."
limitationsPlanned enrolment and endpoints are not findings.
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