Clinical trial NCT06822231: High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases - Fit4MedRob-Acute MND Project
Official title: Clinical Protocol for a Pragmatic Trial on a High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases (Fit4MedRob-Acute MND Project)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness Myopathy
Guillain Barré Syndrome
Critical Illness Polyneuromyopathy (CIPNM)
Keywords: high-tech rehabilitation
acute neuromuscular diseases
robotic platform
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero-Universitaria di Modena
name: Fondazione Don Carlo Gnocchi Onlus
name: Ospedale Policlinico San Martino
First posted: 2025-02-12
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline in Berg Balance Scale
timeFrame: At the end of treatment at day 60
Secondary outcomes:
measure: Change from baseline in Modified Barthel Index
timeFrame: At day 15, at day 30, at day 45, at day 60
measure: Change from baseline in Trunk Control Test
timeFrame: At day 15, at day 30, at day 45, at day 60
measure: Change from baseline in 2-Minute Walk Test
timeFrame: At day 15, at day 30, at day 45, at day 60
measure: Change from baseline in Modified Erasmus GBS Outcome Score
timeFrame: At the end of treatment at day 60
measure: Change from baseline in Handgrip strenght test
timeFrame: At day 15, at day 30, at day 45, at day 60
measure: Change from baseline in Isometric muscles strenght
timeFrame: At day 15, at day 30, at day 45, at day 60
measure: Change from baseline in Numeric Rating Scale
timeFrame: At day 30 and day 60
measure: Change from baseline in 12-Short Form-12 Survey
timeFrame: At day 30 and day 60
measure: Change from baseline in Technology Assisted Rehabilitation Patient Perception Questionnaire
timeFrame: At day 30, at day 60
Other outcomes:
measure: Change from baseline in Insulin Growth Factor 1 and free Insulin Growth Factor 1
timeFrame: At day 15, at day 30, at day 60
measure: Change from baseline in Neurofilament-Light chain
timeFrame: At day 15, at day 30, at day 60
Locations:
city: Bari
country: Italy
facility: Istituti Clinici Scientifici Maugeri
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria San Martino - Genova
city: Milan
country: Italy
facility: Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena
city: Montescano
country: Italy
facility: Istituti Clinici Scientifici Maugeri
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri
city: Roma
country: Italy
facility: Fondazione Don Carlo Gnocchi Onlus
city: Telese Terme
country: Italy
facility: Istituti Clinici Scientifici Maugeri
Study officials:
References: