AzTrials
AzTrials

Critical Illness MyopathyFit4MR-AcMNDNCT06822231

High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases - Fit4MedRob-Acute MND Project

A study testing High-tech rehabilitative treatment and Rehabilitation in people with Critical Illness Myopathy and Guillain Barré Syndrome, run by Istituti Clinici Scientifici Maugeri SpA at 8 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
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
124 participants
Where
8 sitesItaly
Study dates
28 May 2025to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • 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

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 or breastfeeding women.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

8 sites in 1 country

Italy8 sites, 8 recruiting
  • Istituti Clinici Scientifici Maugeri

    Bari, 70124

    Pietro Fiore, MD, +39 0807814111, pietro.fiore@icsmaugeri.it

    Pietro Fiore, MD

    Not yet recruiting
  • IRCCS Azienda Ospedaliera Universitaria San Martino - Genova

    Genova, 16132

    Angelo Schenone, MD, +39 010 3537065, aschenone@neurologia.unige.it

    Angelo Schenone, MD

    Not yet recruiting
  • Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute

    Milan, 20138

    Christian Lunetta, +390250725266, ilaria.consolo@icsmaugeri.it

    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

    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

    Telese Terme, 82037

    Laura Marcuccio, MD, +39 0824909111, laura.marcuccio@icsmaugeri.it

    Laura Marcuccio, MD

    Not yet recruiting

Other trials in Italy

About this study

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

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.

Read the detailed description

Objective: To evaluate the efficacy of a novel rehabilitation protocol integrating advanced technologies in the treatment of acute 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 acute 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 acute NMDs such as Guillain-Barré Syndrome (GBS), Critical illness myopathy (CIM) and polyneuropathy (CIP), either individually or in combination (CIP/CIM). The approach emphasizes rapid rehabilitation to maximize recovery outcomes.

Study Design: An interventional, randomized, superiority case-control study 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 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 acute NMDs. By doing so, it aims to potentially establish a new global standard for the care of patients with NMD care.

Being tested
High-tech rehabilitative treatment, Rehabilitation
Keywords
high-tech rehabilitation, acute neuromuscular diseases, robotic platform
Medical subject headings
Guillain-Barre Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-tech rehabilitative treatmentDevice

    Robotic Verticalization System (e.g., Erigo): Assists in regaining upright posture and mobility.

    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 groups in NCT06822231
Study groupRoleWhat they receive
Robotic treatment groupActive comparatorIn 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).
Receives: Device: High-tech rehabilitative treatment
Control groupOtherThe 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.

  1. Change from baseline in Berg Balance Scale

    Improvement in balance measured by the Berg Balance Scale (BBS), with a target improvement of at least 10 points from baseline to the end of the treatment period. BBS is used to objectively determine a patient's ability (or inability) to safely balance during a series of 14 tasks; each task ranks from 0 to 4, with a total score of 56. Higher score indicates the higher level of function.

    Measured: At the end of treatment at day 60

Secondary outcomes (9)
  1. Change from baseline in Modified Barthel Index

    Modified Barthel Index (MBI). The MBI is an adaptation of the original Barthel Index, designed to assess a patient's ability to perform activities of daily living (ADLs) and their level of independence. The MBI evaluates ten specific functions: Feeding, Bathing, Grooming, Dressing, Bowel control, Bladder control, Toileting, Transfers (e.g., bed to chair), Mobility (e.g., walking or wheelchair use), Stair climbing. Each item is scored on a 5-level ordinal scale. Interpretation: 0-20, Total dependency; 21-60, Severe dependency; 61-90, Moderate dependency; 91-99, Slight dependency; 100, Independence

    Measured: At day 15, at day 30, at day 45, at day 60

  2. Change from baseline in Trunk Control Test

    Trunk Control Test (TCT) for non-ambulatory patients. The TCT is a clinical assessment tool used to evaluate trunk movement control in patients, particularly those who have suffered a stroke or other neurological disorders. The TCT measures four specific movements: 1) Rolling to the weak side: The patient rolls from a supine position to their weaker side; 2) Rolling to the strong side: The patient rolls from a supine position to their stronger side; 3) Balance in a sitting position: The patient sits on the edge of a bed or table without support for at least 30 seconds; 4) Sitting up from lying down: The patient moves from a lying to a sitting position. Each movement is scored on a scale from 0 to 25, with a total possible score of 100. Higher scores indicate better trunk control (Collin \& Wade 1990)

    Measured: At day 15, at day 30, at day 45, at day 60

  3. Change from baseline in 2-Minute Walk Test

    2-Minute Walk Test (2MWT) for ambulatory patients. 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 or feet is recorded

    Measured: At day 15, at day 30, at day 45, at day 60

  4. Change from baseline in Modified Erasmus GBS Outcome Score

    Modified Erasmus GBS Outcome Score (mEGOS) for Guillain-Barrè Syndrome patients: is a clinical prediction model used to estimate the likelihood of a patient with GBS being unable to walk independently six months after disease onset. This score is calculated based on three key factors: 1) Age at onset of neurological symptoms; 2) Preceding diarrhea before the onset of symptoms; 3) Severity of muscle weakness, assessed using the Medical Research Council sum score. The mEGOS provides a score ranging from 0 to 12, with higher scores indicating a higher risk of walking inability

    Measured: At the end of treatment at day 60

  5. Change from baseline in Handgrip strenght test

    Maximal isometric handgrip strength for both right and left hands will be measured using a digital handgrip dynamometer in units of kg/f in the standardized position recommended by the American Society of Hand Therapists, that is, sitting in a chair with a 90° backrest and 90° elbow flexion of the hand to be evaluated. Each participant exerted three trials of 3 s of maximal isometric handgrip strength alternatively for the right and left hands, with a rest period of 180 s between trials and considering the best performance of the three trials for statistical analysis

    Measured: At day 15, at day 30, at day 45, at day 60

  6. Change from baseline in Isometric muscles strenght

    Isometric muscle strength, measured in kg, was assessed using a manual hand-held dynamometer (HHD) at the deltoid, biceps brachii, triceps brachii, wrist flexor, and wrist extensor for the upper limbs bilaterally; thigh flexor, knee extension, knee flexion, dorsiflexion, and plantarflexion for the lower limbs bilaterally

    Measured: At day 15, at day 30, at day 45, at day 60

  7. Change from baseline in Numeric Rating Scale

    Measured using the Numeric Rating Scale (NRS). The NRS for fatigue is a simple and widely used tool to assess the intensity of fatigue. It helps patients communicate their fatigue levels to healthcare providers effectively. The NRS typically uses an 11-point scale ranging from 0 (no fatigue) to 10 ("the worst fatigue imaginable"). Patients are asked to rate their fatigue by selecting a number that best represents their pain intensity at that moment.

    Measured: At day 30 and day 60

  8. Change from baseline in 12-Short Form-12 Survey

    It will be used the 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 30 and day 60

  9. 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 30, at day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2025
  2. Study start28 May 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06822231
Sponsor's protocol ID
2024_0053110
Other IDs
PNC0000007
Acronym
Fit4MR-AcMND
Status last verified
Nov 2026
First submitted
31 Jan 2025
Last updated
4 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing High-tech rehabilitative treatment and Rehabilitation in people with Critical Illness Myopathy and Guillain Barré Syndrome, run by Istituti Clinici Scientifici Maugeri SpA at 8 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christian Lunetta, MD (+39 0250725266, christian.lunetta@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Berg Balance Scale (time frame: At the end of treatment at day 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in