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Clinical Trials/NCT06056960
NCT06056960
Enrolling By Invitation
Not Applicable

Preventing the Progression of Physical Disability and Promoting Brain Functional Adaptation in People With Multiple Sclerosis: Integration of Early Rehabilitative Treatment and Multimodal Clinical and Instrumental Assessment - Part B

Fondazione Don Carlo Gnocchi Onlus3 sites in 1 country80 target enrollmentJuly 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Fondazione Don Carlo Gnocchi Onlus
Enrollment
80
Locations
3
Primary Endpoint
Fatigue Severity Scale (FSS)
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

Brief Summary

It is widely recognized that physical exercise is safe and people with moderate Multiple Sclerosis (MS) are encouraged to train regularly to improve their skills in motor task execution. Several studies demonstrated that these activities represent an effective low-cost therapy which leads to significant and clinically meaningful improvements in gait and balance in people with MS (PwMS) with mild to moderate walking dysfunction, possibly also by promoting brain plasticity.

There is general agreement within the scientific community on the importance of timing intervention also during the early stages of MS to preserve or improve walking and balance abilities and fostering brain functional adaptation, thus slowing down the disease progression. Previous studies highlighted the need to early identify and manage gait disorders using a multimodal approach tailored on individual's need. Moreover, Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity and thus, it can provide spatial information about changes in cortical activation patterns due to the possible effects of exercise on cortical plasticity.

To the best of the investigators knowledge, no published studies have assessed the effect of exercise on mobility and brain activity in PwMS with minimal or clinically undetectable disability. This emphasizes the need of trials investigating the effect of walking exercise as preventive strategy on MS clinical worsening.

Registry
clinicaltrials.gov
Start Date
July 15, 2024
End Date
January 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age \> 17 years
  • Stable disease course (without worsening over 1 point at the Expanded Disability Status Scale in the last 3 months)

Exclusion Criteria

  • Major depression
  • Mini-Mental State Examination \< 27
  • Other cardiovascular or orthopedic diseases that interfere with physical exercise
  • Progressive course of the disease

Outcomes

Primary Outcomes

Fatigue Severity Scale (FSS)

Time Frame: Baseline, Post, FollowUp_6month

Is a 9-item self-administered questionnaire to measure the perceived impact of fatigue. The minimum score is 9 and maximum score possible is 63. Higher scores represent greater fatigue severity. If the score is calculated as the mean score of the 9 items, the cut-off score for the presence of the symptom fatigue is set as scores higher than 4.

Secondary Outcomes

  • Endurance walking capacity(Baseline, Post, FollowUp_6month)
  • Number of steps/day(Baseline, Post, FollowUp_6month)
  • Differences in oxygenated hemoglobin (Delta oxyHb)(Baseline, Post, FollowUp_6month)
  • Six Minute walking test (6MWT)(Baseline, Post, FollowUp_6month)

Study Sites (3)

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