Rehabilitation for balance and gait issues in multiple sclerosis patients using technology

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial focuses on patients with multiple sclerosis (MS) who experience balance and cognitive impairments. It involves a randomized approach where participants are divided into two groups: one receiving technological rehabilitation using the Hunova robotic platform, while the other group undergoes observation before receiving the same treatment. The study aims to evaluate the effectiveness of this innovative rehabilitation method over a 12-month period. Participants will be assessed for their ability to stand and follow instructions, ensuring they meet specific inclusion criteria.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fondazione Policlinico Universitario A. Gemelli IRCCS
  Roma, Rm, Italy Recruiting

Study contacts

• Principal investigator: Silvia Giovannini, MD, phD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Silvia Giovannini, MD, phD
• Email: silvia.giovannini@policlinicogemelli.it
• Phone: +390630154382

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.