NCT06881979 High-Tech Rehabilitation Pathway for Chronic Adult Neuromuscular Diseases - Fit4MedRob-Chronic MND Project
| NCT ID | NCT06881979 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-28 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-04-28 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective is to demonstrate, in a population of chronic neuromuscular disease the non-inferiority of a rehabilitation treatment integrated with robotic and/or technological devices compared to traditional rehabilitation treatment in the level of fatigue. The main question it aims to answer is: Are high-tech rehabilitation interventions, including robotic systems, virtual reality, and stabilometric platforms, not inferior to traditional rehabilitation methods in improving balance, motor function, fatigue levels, sarcopenia, cognitive engagement, and overall quality of life in patients with chronic neuromuscular diseases (NMDs)? Researchers will compare a robotic treatment group, that consists in an high-tech rehabilitation, with a control group, that will receive the traditional rehabilitative treatment.
Eligibility Criteria
Inclusion Criteria: * Patients with a confirmed diagnosis of chronic neuromuscular diseases (e.g. ALS, CIDP, CMT) * Patient able to walk independently or with assistance * Patients capable of understanding and adhering to the study protocol. * Patients who have provided informed consent to participate in the study Exclusion Criteria: * Patients with unstable medical conditions (e.g. severe cardiovascular diseases, such as "New York Heart Association" - NYHA=4, respiratory distress not compensated by ventilation) that could interfere, in the clinician's judgment, with their ability to safely participate in the study or to perform the assessments related to the protocol. * Patients currently participating in other clinical trials that could interfere with this study. * Pregnant women.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06881979 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06881979 currently recruiting?
Yes, NCT06881979 is actively recruiting participants. Contact the research team at christian.lunetta@icsmaugeri.it for enrollment information.
Where is the NCT06881979 trial being conducted?
This trial is being conducted at Genova, Italy, Milan, Italy, Modena, Italy, Montescano, Italy and 3 additional locations.
Who is sponsoring the NCT06881979 clinical trial?
NCT06881979 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The trial plans to enroll 60 participants.
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