An interventional study of Rehabilitation protocol: FES and Rehabilitation protocol without FES in Critical Illness Myopathy and Critical Illness Polyneuropathy, sponsored by Fondazione Don Carlo Gnocchi Onlus. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Treatment
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.
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:
133 studies on the registry are indexed under Polyneuropathies; 33 are open to participants now.
This study's planned enrollment of 72 is above the median of 63 across 70 interventional studies indexed under Polyneuropathies.
Browse Polyneuropathies studies →Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
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Critical Illness Patient Inclusion Criteria:
Critical Illness Patient Exclusion Criteria:
Healthy Subjects Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Rehabilitation protocol: 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.
Other: Rehabilitation protocol: 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 (e.g., overground straight walking), will be performed without FES. The electrical stimulator will be positioned, and the amplitude will be set to zero
Other: Rehabilitation protocol without 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 (e.g., overground straight walking), will be performed without FES. The electrical stimulator will be positioned, and the amplitude will be set to zero
Other: Rehabilitation protocol without FES
Subjects diagnosed with CIP will follow the FES-based rehabilitation protocol
Subjects belonging to the control group will follow the rehabilitation protocol without FES
Subjects diagnosed with CIM will follow the FES-based rehabilitation protocol
Medical Research Council - Sum Score (MRC-SS)
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).
Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)
Walking velocity on 10 meters walking test
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.
Time frame: Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)
Modified Barthel Index
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).
Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)
Instrumented Six Minute Walk Test
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.
Time frame: Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)
Timed Up and Go Test
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.
Time frame: Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)
Euro Quality of Life-5 -dimension Questionnaire
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.
Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)
Client Satisfaction Questionnaire - CSQ
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).
Time frame: After 15 rehabilitation sessions (each session is 60 minutes, T2)
Needle Electromyography-based parameters
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.
Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)
Electroneurography (ENG) and Nerve Conduction Studies
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. Amplitude of Compound Muscle Action Potential (CMAP) (measured in millivolts \[mV\]). 2. Amplitude of Sensory Nerve Action Potential (SNAP) (measured in millivolts \[mV\]).
Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)
Electroneurography (ENG) and Nerve Conduction Studies
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 \[ms\]).
Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)
Postural capabilities will be evaluated based on body kinetics
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.
Time frame: Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)
Fall diary
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.
Time frame: From baseline (T0) to 3-month follow-up (T3)
Report of adverse events
Organized reporting of adverse events occurring during the use of the device
Time frame: From baseline (T0) to post-treatment evaluation, after the 15 rehabilitation sessions (each session is 60 minutes, T2)
Gender data
Gender of enrolled subject
Time frame: Baseline (T0)
Age data
Age of enrolled subject
Time frame: Baseline (T0)
Scholarity data
Scholarity of enrolled subject
Time frame: Baseline (T0)
Plan to share: Yes — Data will be available upon request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Preliminary data will be available at the end of the study
Access criteria: at request to the Principal investigator
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