High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-28

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Critical Illness Myopathy Guillain Barré Syndrome Critical Illness Polyneuromyopathy (CIPNM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Robotic treatment group

In 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).

Group Type ACTIVE_COMPARATOR

High-tech rehabilitative treatment

Intervention Type DEVICE

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

Control group

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

Group Type OTHER

Rehabilitation

Intervention Type OTHER

Traditional rehabilitative treatment

Interventions

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High-tech rehabilitative treatment

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

Intervention Type DEVICE

Rehabilitation

Traditional rehabilitative treatment

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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