Clinical Protocol for a Pragmatic Trial on a High-Tech Rehabilitation Pathway for Chronic Adult Neuromuscular Diseases (Fit4MedRob-Chronic MND Project)

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Azienda Ospedaliera Universitaria San Martino - Genova
NOT_YET_RECRUITING
Genova
Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute
RECRUITING
Milan
Azienda Ospedaliero-Universitaria di Modena
NOT_YET_RECRUITING
Modena
Istituti Clinici Scientifici Maugeri
NOT_YET_RECRUITING
Montescano
Istituti Clinici Scientifici Maugeri IRCCS
NOT_YET_RECRUITING
Pavia
Fondazione Don Carlo Gnocchi Onlus
NOT_YET_RECRUITING
Roma
Istituti Clinici Scientifici Maugeri IRCCS
NOT_YET_RECRUITING
Telese Terme
Contact Information
Primary
Christian Lunetta, MD
christian.lunetta@icsmaugeri.it
+39 0250725266
Time Frame
Start Date: 2025-04-28
Estimated Completion Date: 2026-03
Participants
Target number of participants: 60
Treatments
Active_comparator: Robotic treatment group
In this arm, patients will undergo in motor and cognitive exercise using the VR device (e.g., VRRS EVO), treatment with proprioceptive exercises on a platform (e.g., GEA MASTER or PROKIN Technobody) to enhance postural control, aerobic exercises on a robotic treadmill (e.g. Walkerview Technobody) and usual physiotherapy treatment, such as passive and active assisted exercises
Other: Control group
The patients will receive the traditional rehabilitative treatment according to the good clinical practice according to the Diagnostic, Therapeutic and Care Pathways of each center involved
Sponsors
Collaborators: Fondazione Don Carlo Gnocchi Onlus, Ospedale Policlinico San Martino, Azienda Ospedaliero-Universitaria di Modena
Leads: Istituti Clinici Scientifici Maugeri SpA

This content was sourced from clinicaltrials.gov