Improved Recovery of Walking in Acquired Muscle Weakness

Not Applicable

Recruiting

• Conditions: Critical Illness Myopathy; Critical Illness Polyneuropathy

• Registration Number: NCT06786390
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Study Timeline

• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2025-01-15
• Study First Posted: 2025-01-22
• Status Verified: 2025-02
• Study Start: 2025-02-25
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Medical Research Council - Sum Score (MRC-SS)	Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)	The scale measures six bilateral muscle groups (wrist flexion, elbow flexion, shoulder abduction, ankle dorsiflexion, knee extension and hip flexion) with a maximum score of 60 points (normality) and a minimum score of 0 points (No muscle contraction visible or palpable).

Secondary Outcome Measures

Name	Time	Method
Walking velocity on 10 meters walking test	Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)	Walking speed is measured by the timed 10-meter Walk Test (10MWT). Participants walk a distance of 10 meters at their usual speed with their usual walking aids. Participants are timed while walking 10 meters from a starting point to an end point. Time taken from meter 2 to meter 8. Two repetitions are completed and the average time is used to calculate walking speed in metres/second. During the test, EMG and kinematic data will be recorded using EMG-sensors and three IMUs, two placed on the feet and one on the lower back.
Modified Barthel Index	Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)	Measurement instrument, based on an ordinal scale, commonly used to assess daily life activities. The total score ranges from 0 (total dependency) to 100 (full autonomy).
Instrumented Six Minute Walk Test	Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)	Walking capacity is measured with the Participant timed while walking a 30 meter track constantly for 6 minutes. Participants are permitted to use their walking aids if necessary, and Patients will wear an IMU. The distance walked in 6 minutes is recorded and reported in meters.
Timed Up and Go Test	Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)	The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk. Patient are timed while standing up from a chair walking 3 meters, turning around, walking 3 meters and sitting down again.; The patient sits in the chair with his/her back against the chair back. On the command "go," the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down.; Timing begins at the instruction "go" and stops when the patient is seated.
Euro Quality of Life-5 -dimension Questionnaire	Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)	EQ-5D-5L is a standardized instrument for use as a measure of health for clinical and economic appraisal.Applicable to a wide range of health conditions and treatments, the EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.; Measures the 5 dimensions of: mobility self-care usual activities pain/discomfort anxiety/depression Each dimension is scored on a Likert scale of 5 levels, with higher scores indicating more severe problems.
Client Satisfaction Questionnaire - CSQ	After 15 rehabilitation sessions (each session is 60 minutes, T2)	It measures the degree of satisfaction of the subject in terms of improvement of the treatment received. The total score ranges from 0 (not satisfied) to 40(full satisfied).
Needle Electromyography-based parameters	Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)	Needle Electromyography (EMG) will be used for both qualitative and quantitative analysis of muscle activity.; Collected data: 1. Spontaneous activity: Analysis of fibrillation potentials and positive sharp waves in target muscles of the upper and lower limbs.; 2. Voluntary activity: Analysis of motor unit potential recruitment patterns and amplitude in target muscles of the upper and lower limbs.
Electroneurography (ENG) and Nerve Conduction Studies	Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)	Electroneurography (ENG) data will be collected separately for motor and sensory nerve conduction studies. Direct muscle stimulation will be performed to differentiate predominantly neuropathic from predominantly myopathic forms. Collected data will be: 1. Latency of CMAP (measured in milliseconds \[ms\]).; 2. Latency of SNAP (measured in milliseconds \[ms\]).; 3. Duration of CMAP(measured in milliseconds \[ms\]).; 4. Duration of SNAP (measured in milliseconds \[ms\]).; 5. F-response latency of major nerve trunks (measured in milliseconds \[ms\]).
Postural capabilities will be evaluated based on body kinetics	Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)	Postural data of the lower limb will be acquired using an optoelectronic system combined with two force plates, sampling at 2000 Hz. Utilizing data processing techniques, deviations from normal postural dynamics will be determined.
Fall diary	From baseline (T0) to 3-month follow-up (T3)	Falls diaries gather information about the frequency of falls and the circumstances in which the fall occurred. The information include: date/time of fall; location of fall; what caused the fall; type of injury sustained; action taken.
Report of adverse events	From baseline (T0) to post-treatment evaluation, after the 15 rehabilitation sessions (each session is 60 minutes, T2)	Organized reporting of adverse events occurring during the use of the device

Trial Locations

Locations (1)

IRCCS Fondazione Don Carlo Gnocchi Onlus; 🇮🇹 Milano, Italy