Improved Recovery of Walking in Acquired Muscle Weakness

NCT ID: NCT06786390

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2027-12-31

Brief Summary

The aim of Re-Walk-Easy is to evaluate the effects of rehabilitation based on electrical stimulation on the motor performance of critically ill patients. The study will also investigate the pathophysiology of the two forms-the myopathic-predominant and the polyneuropathic-predominant variants-by examining the longitudinal progression of CIP and CIM and determining which form benefits more from electrical stimulation as a rehabilitative approach.

Detailed Description

Although rehabilitation is often recommended to patients with Intensive Care Unit Acquired Weakness (ICU-AW) to counteract the induced muscle weakness, systematic reviews failed to determine its efficacy. Neuro Muscular Electrical Stimulation (NMES) is part of clinical practice in ICU-AW however its effects are still under debate. The investigators hypothesize that this uncertainty stems from the lack of distinction between the two forms of the condition-Critical Illness Polyneuropathy (CIP) and Critical Illness Myopathy (CIM)-which have distinct pathological features and disease trajectories. In addition, the investigators hypothesize that motivating patients by requiring voluntary muscle activation during the Electrical Stimulation (i.e. Functional Electrical Stimulation - FES) will enhance rehabilitation.

The study will test the following hypothesis through a longitudinal clinical trial aimed at determining:

1. which form will benefit the most from FES based-rehabilitation,

2. the biomarkers of walking recovery in ICU-AW.

Conditions

Critical Illness Myopathy; Critical Illness Polyneuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CIP-FES

Each subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency,

Intentional, repetitive movements, such as lower limb movements within goal-oriented mobility tasks, will be performed, with FES applied in parallel. Two approaches will be used: (i) assistive stimulation for passive patients with poor muscle strength, and (ii) proportional active stimulation for subjects with residual muscle strength.

Group Type: EXPERIMENTAL

Rehabilitation protocol: FES

Intervention Type: OTHER

Subjects diagnosed with CIP will follow the FES-based rehabilitation protocol

CIM-FES

Each subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency,

Intentional, repetitive movements, such as lower limb movements within goal-oriented mobility tasks, will be performed, with FES applied in parallel. Two approaches will be used: (i) assistive stimulation for passive patients with poor muscle strength, and (ii) proportional active stimulation for subjects with residual muscle strength.

Group Type: EXPERIMENTAL

Rehabilitation protocol: FES

Intervention Type: OTHER

Subjects diagnosed with CIM will follow the FES-based rehabilitation protocol

CIP-CON

Each subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency,

Intentional, repetitive movements, such as lower limb movements within goal-oriented mobility tasks (e.g., overground straight walking), will be performed without FES. The electrical stimulator will be positioned, and the amplitude will be set to zero

Group Type: ACTIVE_COMPARATOR

Rehabilitation protocol without FES

Intervention Type: OTHER

Subjects belonging to the control group will follow the rehabilitation protocol without FES

CIM-CON

Each subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency,

Intentional, repetitive movements, such as lower limb movements within goal-oriented mobility tasks (e.g., overground straight walking), will be performed without FES. The electrical stimulator will be positioned, and the amplitude will be set to zero

Group Type: ACTIVE_COMPARATOR

Rehabilitation protocol without FES

Intervention Type: OTHER

Subjects belonging to the control group will follow the rehabilitation protocol without FES

Interventions

Rehabilitation protocol: FES

Subjects diagnosed with CIP will follow the FES-based rehabilitation protocol

Intervention Type: OTHER

Rehabilitation protocol without FES

Subjects belonging to the control group will follow the rehabilitation protocol without FES

Intervention Type: OTHER

Rehabilitation protocol: FES

Subjects diagnosed with CIM will follow the FES-based rehabilitation protocol

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• clinical diagnosis of tetra/paraparesis of peripheral origin as disclosed by ENG/EMG examination;
• be independent before the episode of critical illness

Exclusion Criteria

• history of previous comorbidity for ICU-AW;
• previous known chronic polyneuropathy;
• severe coagulopathy;
• severe disorder of consciousness;
• contraindications to Electrical Stimulation application

• Prosthetic implants
• musculoskeletal, neurological, cardiovascular and pulmonary disorders that may alter the gait

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Fondazione Don Carlo Gnocchi Onlus

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Tiziana Lencioni

Role: CONTACT

tlencioni@dongnocchi.it

00390240308547

Facility Contacts

Tiziana Lencioni

Role: primary

tlencioni@dongnocchi.it

00390240308547

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Other Identifiers

Re-Walk-Easy-SC

Identifier Type: -

Identifier Source: org_study_id