NCT06822231 High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases - Fit4MedRob-Acute MND Project
| NCT ID | NCT06822231 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | Critical Illness Myopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2025-05-28 |
| Primary Completion | 2026-08 |
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 124 participants in total. It began in 2025-05-28 with a primary completion date of 2026-08.
⚠ 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 goal of this study is determine if a high-tech rehabilitation circuit is more effective than usual rehabilitation methods in improving functional outcome, particularly balance control, for patients with acute neuromuscolar diseases. The main question it aims to answer is: Are high-tech rehabilitation interventions, including robotic systems, virtual reality, and stabilometric platforms, more effective than traditional rehabilitation methods in improving balance, motor function, fatigue levels, sarcopenia, cognitive engagement, and overall quality of life in patients with acute 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: * Adults with ages ranging from 18 to 80 years. * Patients with a confirmed diagnosis of acute/subacute neuromuscular diseases (e.g. GBS, CIM, CIP) * Time of onset ranging from 15 to 30 days * Patients with lower limb strength (Medical Research Council or MRC) \>=2 in at least two of the flexor and extensor muscles of the following joints: hip, knee and ankle * Possibility of obtaining informed consent 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 or breastfeeding women.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06822231 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Critical Illness Myopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06822231 currently recruiting?
Yes, NCT06822231 is actively recruiting participants. Contact the research team at christian.lunetta@icsmaugeri.it for enrollment information.
Where is the NCT06822231 trial being conducted?
This trial is being conducted at Bari, Italy, Genova, Italy, Milan, Italy, Modena, Italy and 4 additional locations.
Who is sponsoring the NCT06822231 clinical trial?
NCT06822231 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The trial plans to enroll 124 participants.