Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06881979

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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