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Evaluation of the impact of experimentally induced fatigability on motor and cognitive functions. effect of high intensity training on motor and cognitive functions:a pilot randomized controlled trial

NCT ID NCT06219304

NEW Sponsor: Fondazione Don Carlo Gnocchi ETS Source: ClinicalTrials.gov ↗

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Recruiting now
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Running, but no longer taking on new participants.
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Cancelled
Cancelled before anyone took part.

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Approved
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First seen Sep 10, 2026 · Last updated Sep 10, 2026

Summary

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Sep 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 between 1.5 and 6 points * Must be able to maintain upright posture without any assistance for 30 seconds * Must be able to release a written informed consent. Exclusion Criteria: * MS relapse within the previous three months; * Unable to comprehend the aims of the study and to follow test instructions; * Diagnosis of major depression (DSM-5); * Severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment); * Cardiovascular diseases; * Unconfirmed or uncertain diagnosis of MS (McDonald criteria) * Other concomitant neurological disease; * Patients already performing aerobic or walking exercise.

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Conditions

The condition(s) this trial relates to.

Fatigue multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • Fondazione IRCCS Don Carlo Gnocchi

    Milan, MI, 20148, Italy

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