Rehabilitation for balance and gait issues in multiple sclerosis patients using technology
Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis: Effects on Functional, Motor and Cognitive Outcomes (ROAR-MS).
This study is testing if a new robotic rehabilitation program can help people with multiple sclerosis improve their balance and walking over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT05983809 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a definitive diagnosis of multiple sclerosis and moderate balance issues.
Not a fit: Patients with severe cognitive impairment, significant visual impairment, or unrelated vestibular disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve balance and mobility in patients with multiple sclerosis, enhancing their quality of life.
How similar studies have performed: Previous studies have shown promise in using technology for rehabilitation in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Roma, RM
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.