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
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.
Investigators
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)