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

Overview

Official title

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

Brief title

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

Registration type

ClinicalTrials.gov

NCT number

NCT06881979

Status

Recruiting

Study category

Interventional, Drug trial, Biomarker

Sponsor / center

Istituti Clinici Scientifici Maugeri SpA

Research center

Not stated in the official study record.

Collaborators

Ospedale Policlinico San Martino, Azienda Ospedaliero-Universitaria di Modena, Fondazione Don Carlo Gnocchi ETS

Study type

Interventional study

Phase

Not applicable / observational

Enrollment

60

Start date

04-28-2025

Primary completion date

10-XX-2026

Estimated / actual completion date

11-XX-2026

Last source update

09-21-2026

What is being studied?

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.

Intervention(s)

Who may be eligible?

This is a simplified summary. The official study team or research center determines eligibility.

Population / disease status

Diagnosed ALS

Diagnosis / conditions

Amyotrophic Lateral Sclerosis, Chronic Inflammatory Demyelinating Neuropathy, Charcot-Marie-Tooth Disease

Age

18 Years to 80 Years

Disease duration

Not stated in the official study record.

Respiratory criteria

The official eligibility criteria include language relevant to this topic; review the full criteria below.

ALSFRS-R criteria

Not stated in the official study record.

Genetic criteria

Not stated in the official study record.

Medication requirements

Not stated in the official study record.

Major inclusion and exclusion criteria from the official record

Inclusion Criteria:

* 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

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 women.

Genetics

Gene-specific study?

No

Gene or variant

Any / Not gene-specific

Genetic test required?

Not stated in the official study record.

Known carrier required?

Not stated

Confirmed pathogenic variant required?

Not stated in the official study record.

Presymptomatic carriers eligible?

Not stated in the official study record.

At-risk relative eligible?

Not stated

Genetic test provided?

Not stated in the official study record.

Genetic counseling provided?

Not stated in the official study record.

Results returned / offered?

Not stated

Family history required?

Not stated in the official study record.

Study design

Randomized?

Not stated in the official study record.

Allocation

Not stated in the official study record.

Intervention model

Not stated in the official study record.

Masking

Not stated in the official study record.

Placebo

Not stated in the official study record.

Primary purpose

Not stated in the official study record.

Endpoints

Primary outcome measures

• Change from baseline in Fatigue Severity Scale

Secondary outcome measures

• Change from baseline in Time Up and Go Test
• Change from baseline in 2-Minute Walking Test
• Change from baseline in 12-Item Short Form Survey (SF-12)
• Change from baseline in Technology Assisted Rehabilitation Patient Perception Questionnaire
• Change from baseline in Charcot-Marie-Tooth disease neuropathy score
• Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale Revised

A biomarker outcome should not automatically be interpreted as a clinical outcome.

Locations

Contact

Central contact: Christian Lunetta, MD · christian.lunetta@icsmaugeri.it · +39 0250725266