Improved Recovery of Walking in Acquired Muscle Weakness (Re-Walk-Easy)

Don Carlo Gnocchi Onlus Foundation

Status: Enrolling

Conditions: Critical Illness Polyneuropathy; Critical Illness Myopathy

Treatments: Other: Rehabilitation protocol without FES; Other: Rehabilitation protocol: FES

Study type: Interventional

Funder types: Other

Identifiers

NCT06786390

Re-Walk-Easy-SC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Critical Illness Patient Inclusion Criteria:

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

Critical Illness Patient Exclusion Criteria:

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

Healthy Subjects Exclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 4 patient groups

CIP-FES

Experimental group

Description:

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.

Treatment:

Other: Rehabilitation protocol: FES

Other: Rehabilitation protocol: FES

CIM-FES

Experimental group

Description:

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.

Treatment:

Other: Rehabilitation protocol: FES

Other: Rehabilitation protocol: FES

CIP-CON

Active Comparator group

Description:

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

Treatment:

Other: Rehabilitation protocol without FES

CIM-CON

Active Comparator group

Description:

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

Treatment:

Other: Rehabilitation protocol without FES