Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06219304

Effect of High Intensity Training on Motor and Cognitive Functions

Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-07-08

30

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

Sponsors

F

Fondazione Don Carlo Gnocchi Onlus

Lead Sponsor

E

Ente Ospedaliero Ospedali Galliera

Collaborating Sponsor

AI-Summary

What this Trial Is About

Fatigability is one of the most prevalent disorder in MS followed by walking, balance and cognitive disorders. However, there are few experimental studies on the effects of fatigability on balance and gait hampering the knowledge of causal fatigue-related changes of walking, balance and cognition. Nowadays, instrumented systems such as wearable devices and optoelectronic systems are available and can be used to provide quantitative and objective indexes useful to monitor the changes of gait parameters during a fatiguing performance. (Moreover), instrumented assessment of patients' performances in dual task paradigms can reveal the possible impact of fatigability on cognitive functions. So far, high intensity functional training has been already used in MS to reduce fatigability. However, the true impact of reduced fatigability on walking, balance and cognition has not been assessed after a fatiguing task making impossible to understand the real impact of treatments focusing on fatigability on these functions. Thus, the aims of the present proposal are to assess the: 1) the acute effect of experimentally induced motor fatigability on walking, balance and cognitive functions using an objective instrumented assessment before, during, and after an overground fatiguing walking test. 2) to investigate the effect of high intensity multimodal functional training to improve motor and cognitive disorders.

CONDITIONS

Official Title

Effect of High Intensity Training on Motor and Cognitive Functions

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • More than 18 years of age
  • Clinical diagnosis of Multiple Sclerosis (MS)
  • Stable disease course without worsening more than 1 EDSS point over the last 3 months
  • EDSS score between 1.5 and 6 points
  • Ability to maintain upright posture without assistance for 30 seconds
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • MS relapse within the previous three months
  • Inability to understand the study and follow test instructions
  • Diagnosis of major depression (DSM-5)
  • Severe joint or bone disorders affecting balance and walking
  • Cardiovascular diseases
  • Unconfirmed or uncertain MS diagnosis (McDonald criteria)
  • Other neurological diseases
  • Currently performing aerobic or walking exercise regularly

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Don Carlo Gnocchi

Milan, MI, Italy, 20148

Actively Recruiting

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Research Team

E

Elisa Gervasoni, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Effect of High Intensity Training on Motor and Cognitive Functions | DecenTrialz