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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Italy
Fondazione IRCCS Don Carlo Gnocchi
RECRUITING
Milan
Contact Information
Primary
Elisa Gervasoni, Phd
egervasoni@dongnocchi.it
3334534540
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Multimodal functional training
Multimodal training to reduce fatigue and to improve balance and strength
Active_comparator: Usual care
Rehabilitative intervention to improve balance and mobility
Related Therapeutic Areas
Sponsors
Collaborators: Fondazione Italiana Sclerosi Multipla, Ente Ospedaliero Ospedali Galliera
Leads: Fondazione Don Carlo Gnocchi Onlus

This content was sourced from clinicaltrials.gov