Amyotrophic Lateral SclerosisFit4MR-ChrMNDNCT06881979
High-Tech Rehabilitation Pathway for Chronic Adult Neuromuscular Diseases - Fit4MedRob-Chronic MND Project
A study testing High-tech rehabilitative treatment and Rehabilitation in people with Amyotrophic Lateral Sclerosis and Chronic Inflammatory Demyelinating Neuropathy, run by Istituti Clinici Scientifici Maugeri SpA at 7 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Chronic Inflammatory Demyelinating Neuropathy, Charcot-Marie-Tooth Disease
- What is being tested?
- High-tech rehabilitative treatment and Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesItaly
- Study dates
- 28 Apr 2025to Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 women.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Italy7 sites, 7 recruiting
- Not yet recruiting
IRCCS Azienda Ospedaliera Universitaria San Martino - Genova
Genova, 16132
Angelo Schenone, MD, aschenone@neurologia.unige.it
Angelo Schenone, MD
- Recruiting
Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute
Milan, 20138
Christian Lunetta, MD, +39 0250725266, christian.lunetta@icsmaugeri.it
Ilaria Consolo, ilaria.consolo@icsmaugeri.it
- Not yet recruiting
Azienda Ospedaliero-Universitaria di Modena
Modena, 41126
Jessica Mandrioli, MD, +39 059 3961658, jmandrio@unimore.it
Jessica Mandrioli, MD
- Not yet recruiting
Istituti Clinici Scientifici Maugeri
Montescano, 27040
Cira Fundarò, MD, +39 0385247268, cira.fundaro@icsmaugeri.it
Cira Fundarò, MD
- Not yet recruiting
Istituti Clinici Scientifici Maugeri IRCCS
Pavia, 27100
Antonio Nardone, MD, +39 0382592637, antonio.nardone@icsmaugeri.it
Antonio Nardone, MD
- Not yet recruiting
Fondazione Don Carlo Gnocchi Onlus
Roma, 00135
Irene Aprile, MD, +39 06 33086500, iaprile@dongnocchi.it
Irene Aprile, MD
- Not yet recruiting
Istituti Clinici Scientifici Maugeri IRCCS
Telese Terme, 82037
Laura Marcuccio, MD, +39 0824909111, laura.marcuccio@icsmaugeri.it
Laura Marcuccio, MD
About this study
Official title: Clinical Protocol for a Pragmatic Trial on a High-Tech Rehabilitation Pathway for Chronic Adult Neuromuscular Diseases (Fit4MedRob-Chronic MND Project)
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.
Read the detailed description
Objective: To evaluate the efficacy of a novel rehabilitation protocol integrating advanced technologies in the treatment of chronic neuromuscular diseases (NMDs).
Background: NMDs affect muscle function and are directly controlled by the nervous system. Traditional rehabilitation often falls short in addressing the multifaceted needs of NMD patients. This gap underscores the necessity for innovative rehabilitation approaches that can significantly enhance the quality of life and optimize recovery outcomes following acute events.
Methods: The protocol integrates advanced technologies to address the rehabilitation needs of patients with chronic NMDs. It utilizes robotic systems to ensure consistent and precise movement, virtual reality for immersive and engaging therapy, and stabilometric platforms to enhance balance training. The focus is on chronic NMDs such as Amyotrophic Lateral Sclerosis (ALS), Chronic Inflammatory Demyelinating Polyneuropathy (CIPD) and Charcot-Marie-Tooth neuropathy (CMT). The approach emphasizes rapid rehabilitation to maximize recovery outcomes.
Study Design: An interventional, randomized, pragmatic trial with a parallel assignment. The trial aims to compare the efficacy of high-tech rehabilitation methods against conventional treatments in improving patient outcomes.
Outcome Measures: To assess the improvement of at least 10 points in balance measured using the Berg Balance Scale (BBS) from baseline to the end of the treatment period comparing the high-tech rehabilitation circuit with standard rehabilitation protocol. Conclusion: This protocol seeks to determine if high-tech rehabilitation interventions can outperform traditional methods in chronic NMDs. By doing so, it aims to potentially establish a new global standard for the care of patients with NMD care.
- Conditions
- Amyotrophic Lateral Sclerosis, Chronic Inflammatory Demyelinating Neuropathy, Charcot-Marie-Tooth Disease
- Being tested
- High-tech rehabilitative treatment, Rehabilitation
- Keywords
- high-tech rehabilitation, chronic neuromuscular disease, robotic platform
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Charcot-Marie-Tooth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-tech rehabilitative treatmentDevice
Virtual Reality (e.g., VRRS Evo): Provides an engaging and immersive environment for cognitive and motor exercises. Stabilometric Platform (e.g., Gea Master or Prokin Technobody): Used for balance and postural control training. Treadmill System (e.g., Walkerview Technobody): Used for aerobic exercises with gait analysis and feedback
RehabilitationOther
Traditional rehabilitative treatment
| Study group | Role | What they receive |
|---|---|---|
| Robotic treatment group | Active comparator | 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 Receives: Device: High-tech rehabilitative treatment |
| Control group | Other | 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 Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Fatigue Severity Scale
The Fatigue Severity Scale questionnaire contains nine statements that rate the severity of the fatigue symptoms (from 1 to 7, where 1 means complete disagreement with the statement and 7 means complete agreement).
Measured: At day 0, at day 15, at day 30, at day 45, at day 60
Secondary outcomes (6)
Change from baseline in Time Up and Go Test
Timed Up and Go Test (TUG) is a simple test used to assess mobility, balance and locomotor performance. It uses the time that a person need to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair and sit down while turning 180 degrees. The shorter the time taken to perform the test, the better the patient's mobility.
Measured: At day 0, at day 15, at day 30, at day 45, at day 60
Change from baseline in 2-Minute Walking Test
The Two-Minute Walk Test (2MWT) is a simple and quick assessment used to measure a person's walking endurance and functional mobility. It is based on the measurement of the distance that a person can walk in two minutes. The individual is instructed to walk as far as possible in two minutes, typically along a marked course. Assistive devices can be used if needed but should be kept consistent across tests. The total distance walked in meters is recorded.
Measured: At day 0, at day 15, at day 30, at day 45, at day 60
Change from baseline in 12-Item Short Form Survey (SF-12)
The SF-12 is a self-reported questionnaire designed to measure health-related quality of life. It is a shortened version of the SF-36, created to reduce the burden on respondents while still providing reliable and valid results. The SF-12 covers eight health domains: Physical functioning; Role-physical (limitations due to physical health problems); Bodily pain; General health; Vitality (energy and fatigue); Social functioning; Role-emotional (limitations due to emotional problems); Mental health (psychological distress and well-being). The survey produces two summary scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). These scores are norm-based, with a mean of 50 and a standard deviation of 10. Scores above 50 indicate better-than-average health related quality of life, while scores below 50 suggest below-average health.
Measured: At day 0, at day 30 and day 60
Change from baseline in Technology Assisted Rehabilitation Patient Perception Questionnaire
To assess the patient perception of the technology assisted rehabilitation using the Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q). The TARPP-Q consists of 10 questions with multiple choice answers, totalling 29 items. The Questionnaire assesses patients' personal experiences and perceptions of technology assisted rehabilitation, including aspects like usability, positive attitude, hindrance perception, and distress.
Measured: At day 0, at day 30, at day 60
Change from baseline in Charcot-Marie-Tooth disease neuropathy score
The Charcot-Marie-Tooth Neuropathy Score (CMTNS) is a clinical scale used to assess the severity of Charcot-Marie-Tooth neuropathy. This scale is used both to monitor disease progression and to assess the effectiveness of potential experimental treatments. Consists of 9 items, grouped into 3 major categories: Patient-Reported Symptoms, Clinical Examination and Electrophysiological data. Each item is scored from 0 to 4, where 0 means no impairment and 4 very severe impairment, with a total score ranges from 0 to 36.
Measured: At day 0, day 30 and day 60
Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale Revised
The Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) is a scale that includes 12 questions, related to bulbar, motor and respiratory function. This scale is commonly used to evaluate the severity and progression of Amyotrophic Lateral Sclerosis. Each item can have a score from 0 to 4, with a maximum total score of 48, where a score of 0 would indicate no function while a score of 4 would indicate normal function.
Measured: At day 0, at day 30 and at day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start28 Apr 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale Policlinico San Martino, Azienda Ospedaliero-Universitaria di Modena, Fondazione Don Carlo Gnocchi ETS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881979
- Sponsor's protocol ID
- 2025_0003585
- Other IDs
- PNC0000007, 2025
- Acronym
- Fit4MR-ChrMND
- Status last verified
- Sep 2026
- First submitted
- 11 Mar 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No