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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство High-tech rehabilitative treatment
  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
• Другое Rehabilitation
  Traditional rehabilitative treatment

Первичные конечные точки

• Change from baseline in Fatigue Severity Scale [Срок оценки: At day 0, at day 15, at day 30, at day 45, at day 60]

Вторичные конечные точки (6)

• Change from baseline in Time Up and Go Test [Срок оценки: At day 0, at day 15, at day 30, at day 45, at day 60]
• Change from baseline in 2-Minute Walking Test [Срок оценки: 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) [Срок оценки: At day 0, at day 30 and day 60]
• Change from baseline in Technology Assisted Rehabilitation Patient Perception Questionnaire [Срок оценки: At day 0, at day 30, at day 60]
• Change from baseline in Charcot-Marie-Tooth disease neuropathy score [Срок оценки: At day 0, day 30 and day 60]
• Change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale Revised [Срок оценки: At day 0, at day 30 and at day 60]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Италия · 7 центров

• IRCCS Azienda Ospedaliera Universitaria San Martino - Genova — Genova
• Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute — Milan
• Azienda Ospedaliero-Universitaria di Modena — Modena
• Istituti Clinici Scientifici Maugeri — Montescano
• Istituti Clinici Scientifici Maugeri IRCCS — Pavia
• Fondazione Don Carlo Gnocchi Onlus — Roma
• Istituti Clinici Scientifici Maugeri IRCCS — Telese Terme

Идентификаторы

NCT: NCT06881979 · 2025_0003585 · PNC0000007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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