Effect of High Intensity Training on Motor and Cognitive Functions

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Multimodal functional training
  • Usual care

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fondazione Don Carlo Gnocchi Onlus

Lead sponsor

Ente Ospedaliero Ospedali Galliera

Collaborator

Fondazione Italiana Sclerosi Multipla

Collaborator