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Clinical Trials/NCT06219291
NCT06219291
Enrolling by Invitation
N/A

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 A

Fondazione Don Carlo Gnocchi Onlus3 sites in 1 country80 target enrollmentJuly 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Fondazione Don Carlo Gnocchi Onlus
Enrollment
80
Locations
3
Primary Endpoint
Six Minute Walk test (SMWT)
Status
Enrolling by Invitation
Last Updated
2 years ago

Overview

Brief Summary

Motor performance of people with Multiple Sclerosis (PwMS) can decline since the onset of the disease.

Longitudinal studies are needed to detect early worsening in mobility and balance using wearable devices for activity tracking and neurophysiological techniques for investigating brain functional adaptation. Similarly, neurophysiological assessment can provide evidences on the integrity of brain motor networks and mechanisms underlying cortical plasticity in the early disease phase, potentially providing a set of reliable prognostic factors of disease progression in early diagnosed PwMS.

Furthermore, disease progression might be delayed using physical activity, which is effective in PwMS with moderate disability to ameliorate mobility and promoting brain reorganization and seems promising also for PwMS in the early stages of the disease. Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity, thus, it can provide spatial information about changes in cortical activation patterns and it could represent a useful tool for studying the effect of exercise on cortical plasticity. The aims of the study in non-disabled PwMS are: 1) a) to assess the presence of subclinical balance and walking impairments using wearable devices and multimodal gait analysis and b) to investigate cortical activity during exercise, 2) to define prognostic factors associated to disease progression and 3) to study the efficacy of physical activity in preventing the worsening of mobility and stimulating brain functional adaptation.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
December 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age \> 17 years
  • Stable disease course (without worsening over 1 point at the EDSS in the last 3 months)
  • Expanded Disability Status Scale (EDSS) \<2.5

Exclusion Criteria

  • Major depression
  • Mini-Mental State Examination \< 27
  • Other cardiovascular or orthopedic diseases that interfere with physical exercise
  • Undefined or not confirmed diagnosis of MS (Polman criteria)
  • Progressive course of the disease

Outcomes

Primary Outcomes

Six Minute Walk test (SMWT)

Time Frame: Baseline, Follow-up 1year, Follow-up 2year

Assesses distance in meters walked over 6 minutes as a sub-maximal test of endurance capacity.

Secondary Outcomes

  • Regularity of gait(Baseline, Follow-up 1year, Follow-up 2yearr)
  • Concentration of oxygenated hemoglobin (Delta oxyHb)(Baseline, Follow-up 1year, Follow-up 2year)
  • Expanded Disability Status Scale (EDSS)(Baseline, Follow up 1year, Follow up 2year)

Study Sites (3)

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