Preventing the Progression of Multiple Sclerosis: Early Rehabilitative
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
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Tailored Physical Activity
What it measured
Main measures
Fatigue Severity Scale (FSS)
Baseline, Post, FollowUp_6month
Fatigue
Other measures (4)
Differences in oxygenated hemoglobin (Delta oxyHb)
Baseline, Post, FollowUp_6month
Six Minute walking test (6MWT)
Baseline, Post, FollowUp_6month
Walking and mobilityNumber of steps/day
Baseline, Post, FollowUp_6month
Endurance walking capacity
Baseline, Post, FollowUp_6month
Walking and mobility
Who could take part
MS (type not specified) · 18 to 70
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Jul 2024
Main results due
Jan 2025
Finished
Jan 2025