Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part B

Don Carlo Gnocchi Onlus Foundation

Status: Invitation-only

Conditions: Multiple Sclerosis

Treatments: Other: Tailored Physical Activity

Study type: Interventional

Funder types: Other

Identifiers

NCT06056960

03_17/02/2021 Part B

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Physical Activity

Experimental group

Description:

The experimental group will perform a combination of endurance and balance training tailored to the subject.

Treatment:

Other: Tailored Physical Activity

Usual Activity

No Intervention group

Description:

The control group will perform their usual daily activities.