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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Istituti Clinici Scientifici Maugeri
NOT_YET_RECRUITING
Bari
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
NOT_YET_RECRUITING
Pavia
Fondazione Don Carlo Gnocchi Onlus
NOT_YET_RECRUITING
Roma
Istituti Clinici Scientifici Maugeri
NOT_YET_RECRUITING
Telese Terme
Contact Information
Primary
Christian Lunetta, MD
christian.lunetta@icsmaugeri.it
+39 0250725266
Time Frame
Start Date: 2025-05-28
Estimated Completion Date: 2026-02
Participants
Target number of participants: 124
Treatments
Active_comparator: Robotic treatment group
In this arm, patients will be divided into 3 treatment types based on their Berg Balance Scale (BBS) score at the time of randomization. Phase 1 (BBS \<= 20) involves treatment with a robotic verticalization system (ERIGO) and action observation training with a virtual reality device.~Phase 2 (21 \< BBS \< 40) involves treatment with a robotic verticalization system (ERIGO), action observation training with a virtual reality device, and proprioceptive exercises on robotic platforms (e.g. GEA MASTER or PROKIN Technobody).~Phase 3 (BBS \>= 41) involves motor and cognitive exercises using virtual reality device, proprioceptive exercises on robotic platforms (e.g. GEA MASTER or PROKIN Technobody), and aerobic exercises on a robotic treadmill (e.g. Walkerview Technobody).
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
Related Therapeutic Areas
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