Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis.

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Aug 2, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how a special robotic device can help improve balance and walking abilities in people with multiple sclerosis (MS). MS is a condition that affects the nervous system, often causing difficulties with movement, balance, and thinking. The study aims to see if using this robotic platform can enhance both static balance (standing still) and dynamic balance (moving), as well as help with fatigue, cognitive performance, and overall quality of life.

To participate in the trial, individuals must be between 18 and 65 years old and have a confirmed diagnosis of MS. They should be able to stand without support for at least 60 seconds and have stable health without recent flare-ups of their condition. Participants will engage in rehabilitation workouts using the robotic device and will be monitored for improvements in balance, walking, and cognitive skills. This study is currently recruiting participants who meet these criteria, and it could provide valuable insights into new rehabilitation strategies for those living with MS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Definitive diagnosis of multiple sclerosis according to McDonald criteria;
• • Age between 18 and 65 years;
• • Pyramidal or cerebellar system with a score ≥ 2 on the EDSS;
• • EDSS between 2 and 3;
• • Ability to stand without support for 60 seconds;
• • Stability of disease-modifying treatment and absence of clinical relapse of the disease for at least 1 year;
• • Cognitive ability to execute simple orders and understand the physiotherapist's instructions \[assessed by Token Test (score ≥ 26.5)\];
• • Ability to understand and sign informed consent.
• Exclusion Criteria:
• • Significant visual impairment, defined by a visual system score ≥ 2 on the EDSS;
• • Presence of vestibular disorders unrelated to MS;
• • Presence of psychiatric disorders or severe cognitive impairment, i.e. a Mini Mental State Examination (MMSE) score \< 24 (15);
• • Presence of cardiovascular and respiratory disorders;
• • Inability to provide informed consent.