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临床试验/NCT06219291
NCT06219291Enrolling By Invitation不适用

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 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
80
试验地点
3
主要终点
Six Minute Walk test (SMWT)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Six Minute Walk test (SMWT)

时间窗: Baseline, Follow-up 1year, Follow-up 2year

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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