Actively Recruiting
Clinical Protocol for a Pragmatic Trial on a High-Tech Rehabilitation Pathway for Chronic Adult Neuromuscular Diseases (Fit4MedRob-Chronic MND Project)
Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2025-06-11
60
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Istituti Clinici Scientifici Maugeri SpA
Lead Sponsor
O
Ospedale Policlinico San Martino
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether a rehabilitation program that uses advanced technologies like robotic systems, virtual reality, and stabilometric platforms is not worse than traditional rehabilitation in reducing fatigue and improving balance, motor skills, and quality of life in adults with chronic neuromuscular diseases such as ALS, CIDP, and Charcot-Marie-Tooth disease. The study is designed as an interventional, randomized, double-blind trial to compare these two rehabilitation approaches. Participants will be assigned to one of two groups: the robotic treatment group or the control group. The robotic group will engage in motor and cognitive exercises using devices such as VRRS EVO for virtual reality, GEA MASTER or PROKIN Technobody platforms for balance training, and Walkerview Technobody robotic treadmills for aerobic exercises, combined with usual physiotherapy. The control group will receive traditional rehabilitation treatments as per standard clinical practice. Treatment effects will be measured over a 60-day period. During the study, participants will undergo various assessments including fatigue severity, walking and mobility tests, quality of life surveys, patient perception questionnaires, and disease-specific functional rating scales at multiple time points from baseline to day 60. Researchers will monitor changes in these measures to determine the impact of the high-tech rehabilitation compared to traditional methods. The total participation time includes multiple visits and evaluations during the study timeline ending in March 2026.
CONDITIONS
Brief Title
High-Tech Rehabilitation Pathway for Chronic Adult Neuromuscular Diseases - Fit4MedRob-Chronic MND Project
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a confirmed diagnosis of chronic neuromuscular diseases (e.g. ALS, CIDP, CMT)
- Patients aged between 18 and 80 years
- Able to walk independently or with assistance
- Capable of understanding and following the study protocol
- Provided informed consent to participate in the study
You will not qualify if you...
- Unstable medical conditions such as severe cardiovascular disease (NYHA=4) or respiratory distress not managed by ventilation that may affect safe participation
- Currently participating in other clinical trials that could interfere with this study
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 60 days
Participants undergo either a high-tech rehabilitative treatment involving virtual reality, stabilometric platform exercises, and robotic treadmill aerobic exercises combined with usual physiotherapy, or traditional rehabilitative treatment according to good clinical practice.
Visits at day 0, 15, 30, 45, and 60 for assessments
Trial Site Locations
Total: 7 locations
1
IRCCS Azienda Ospedaliera Universitaria San Martino - Genova
Genova, Italy, 16132
Not Yet Recruiting
2
Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute
Milan, Italy, 20138
Actively Recruiting
3
Azienda Ospedaliero-Universitaria di Modena
Modena, Italy, 41126
Not Yet Recruiting
4
Istituti Clinici Scientifici Maugeri
Montescano, Italy, 27040
Not Yet Recruiting
5
Istituti Clinici Scientifici Maugeri IRCCS
Pavia, Italy, 27100
Not Yet Recruiting
6
Fondazione Don Carlo Gnocchi Onlus
Roma, Italy, 00135
Not Yet Recruiting
7
Istituti Clinici Scientifici Maugeri IRCCS
Telese Terme, Italy, 82037
Not Yet Recruiting
Research Team
C
Christian Lunetta, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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