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Critical Illness MyopathyRe-Walk-EasyNCT06786390

Improved Recovery of Walking in Acquired Muscle Weakness

A study testing Rehabilitation protocol: FES and Rehabilitation protocol without FES in people with Critical Illness Myopathy and Critical Illness Polyneuropathy, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
What is being tested?
Rehabilitation protocol: FES and Rehabilitation protocol without FES
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteItaly
Study dates
25 Feb 2025to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tiziana Lencioni contact

00390240308547

tlencioni@dongnocchi.it

Italy1 site, 1 recruiting

  • IRCCS Fondazione Don Carlo Gnocchi Onlus

    Milan, 20148

    Tiziana Lencioni, 00390240308547, tlencioni@dongnocchi.it

    Recruiting

Other trials in Italy

About this study

Official title: Regaining Walking Ability Easier and Better in Critical Illness Polyneuropathy and Myopathy

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.

Read the 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.
Being tested
Rehabilitation protocol: FES, Rehabilitation protocol without FES
Keywords
Functional Electrical Stimulation, Acquired Muscle Weakness, Rehabilitation
Medical subject headings
Polyneuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rehabilitation protocol: FESOther

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

  • Rehabilitation protocol without FESOther

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

  • Rehabilitation protocol: FESOther

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

Study groups in NCT06786390
Study groupRoleWhat they receive
CIP-FESExperimentalEach 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.
Receives: Other: Rehabilitation protocol: FES
CIM-FESExperimentalEach 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.
Receives: Other: Rehabilitation protocol: FES
CIP-CONActive comparatorEach 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
Receives: Other: Rehabilitation protocol without FES
CIM-CONActive comparatorEach 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
Receives: Other: Rehabilitation protocol without FES

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)

Secondary outcomes (12)

  1. 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.

    Measured: Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)

  2. 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).

    Measured: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)

  3. 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.

    Measured: Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)

  4. 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.

    Measured: Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)

  5. 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.

    Measured: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)

  6. 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).

    Measured: After 15 rehabilitation sessions (each session is 60 minutes, T2)

  7. 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.

    Measured: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)

  8. 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]).

    Measured: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)

  9. 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]).

    Measured: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)

  10. 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.

    Measured: Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)

  11. 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.

    Measured: From baseline (T0) to 3-month follow-up (T3)

  12. Report of adverse events

    Organized reporting of adverse events occurring during the use of the device

    Measured: From baseline (T0) to post-treatment evaluation, after the 15 rehabilitation sessions (each session is 60 minutes, T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2025
  2. Study start25 Feb 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A double-blind longitudinal RCT will be performed. The subjects enrolled will be divided in two groups on the basis of their diagnosis, CIP/CIM. Subsequently subjects will be randomly assigned either to the experimental group (FES), or to the control group (CON).
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06786390
Sponsor's protocol ID
Re-Walk-Easy-SC
Acronym
Re-Walk-Easy
Status last verified
Feb 2025
First submitted
19 Dec 2024
Last updated
3 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be available upon request

Publications

  • Van Lancker K, Bretz F, Dukes O. Covariate adjustment in randomized controlled trials: General concepts and practical considerations. Clin Trials. 2024 Aug;21(4):399-411. doi: 10.1177/17407745241251568. Epub 2024 Jun 2.

    PubMed 38825841

  • Dobkin BH. Progressive Staging of Pilot Studies to Improve Phase III Trials for Motor Interventions. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):197-206. doi: 10.1177/1545968309331863.

    PubMed 19240197

  • Gordon T. Electrical Stimulation to Enhance Axon Regeneration After Peripheral Nerve Injuries in Animal Models and Humans. Neurotherapeutics. 2016 Apr;13(2):295-310. doi: 10.1007/s13311-015-0415-1.

    PubMed 26754579

  • Jonsdottir J, Thorsen R, Aprile I, Galeri S, Spannocchi G, Beghi E, Bianchi E, Montesano A, Ferrarin M. Arm rehabilitation in post stroke subjects: A randomized controlled trial on the efficacy of myoelectrically driven FES applied in a task-oriented approach. PLoS One. 2017 Dec 4;12(12):e0188642. doi: 10.1371/journal.pone.0188642. eCollection 2017.

    PubMed 29200424

  • Perini G, Bertoni R, Thorsen R, Carpinella I, Lencioni T, Ferrarin M, Jonsdottir J. Sequentially applied myoelectrically controlled FES in a task-oriented approach and robotic therapy for the recovery of upper limb in post-stroke patients: A randomized controlled pilot study. Technol Health Care. 2021;29(3):419-429. doi: 10.3233/THC-202371.

    PubMed 33386831

  • Connolly B, O'Neill B, Salisbury L, McDowell K, Blackwood B; Enhanced Recovery After Critical Illness Programme Group. Physical rehabilitation interventions for adult patients with critical illness across the continuum of recovery: an overview of systematic reviews protocol. Syst Rev. 2015 Sep 29;4:130. doi: 10.1186/s13643-015-0119-y.

    PubMed 26419458

  • Mehrholz J, Pohl M, Kugler J, Burridge J, Muckel S, Elsner B. Physical rehabilitation for critical illness myopathy and neuropathy: an abridged version of Cochrane Systematic Review. Eur J Phys Rehabil Med. 2015 Oct;51(5):655-61. Epub 2015 Jul 9.

    PubMed 26158919

  • Liu M, Luo J, Zhou J, Zhu X. Intervention effect of neuromuscular electrical stimulation on ICU acquired weakness: A meta-analysis. Int J Nurs Sci. 2020 Mar 10;7(2):228-237. doi: 10.1016/j.ijnss.2020.03.002. eCollection 2020 Apr 10.

    PubMed 32685621

  • Garcia-Perez-de-Sevilla G, Sanchez-Pinto Pinto B. Effectiveness of physical exercise and neuromuscular electrical stimulation interventions for preventing and treating intensive care unit-acquired weakness: A systematic review of randomized controlled trials. Intensive Crit Care Nurs. 2023 Feb;74:103333. doi: 10.1016/j.iccn.2022.103333. Epub 2022 Oct 22.

    PubMed 36283894

  • Wang W, Xu C, Ma X, Zhang X, Xie P. Intensive Care Unit-Acquired Weakness: A Review of Recent Progress With a Look Toward the Future. Front Med (Lausanne). 2020 Nov 23;7:559789. doi: 10.3389/fmed.2020.559789. eCollection 2020.

    PubMed 33330523

  • Latronico N, Bolton CF. Critical illness polyneuropathy and myopathy: a major cause of muscle weakness and paralysis. Lancet Neurol. 2011 Oct;10(10):931-41. doi: 10.1016/S1474-4422(11)70178-8.

    PubMed 21939902

Questions about this trial

What is this clinical trial studying?

A study testing Rehabilitation protocol: FES and Rehabilitation protocol without FES in people with Critical Illness Myopathy and Critical Illness Polyneuropathy, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tiziana Lencioni (00390240308547, tlencioni@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medical Research Council - Sum Score (MRC-SS) (time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06786390, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.

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