Clinical trial Recruiting at 1 site Interventional Ages 18 to 85

Improving walking recovery in patients with muscle weakness from critical illness

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

Run by Fondazione Don Carlo Gnocchi ETS · NCT06786390 · Data updated 2026-11-12

This study is testing if using electrical stimulation during rehabilitation can help critically ill patients with muscle weakness walk better and recover faster.

More Critical Illness trials

Quick facts

Study typeInterventional
Ages18 Years to 85 Years
SexAll
Enrollment72 (estimated)
SponsorFondazione Don Carlo Gnocchi ETS
Academic / other
Locations1 site (Milan)
StatusRecruiting
StartedFebruary 25, 2025
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedMarch 3, 2025
Trial IDNCT06786390 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are critically ill patients diagnosed with tetra/paraparesis of peripheral origin who were independent prior to their illness.

Probably not a fit

Patients with a history of chronic polyneuropathy or severe coagulopathy, as well as those with severe disorders of consciousness, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effects of rehabilitation using Functional Electrical Stimulation (FES) on the motor performance of critically ill patients suffering from Critical Illness Myopathy (CIM) and Critical Illness Polyneuropathy (CIP). It aims to distinguish which variant benefits more from FES-based rehabilitation and to identify biomarkers associated with walking recovery. The study will involve a longitudinal clinical trial comparing rehabilitation protocols with and without FES. The hypothesis is that voluntary muscle activation during electrical stimulation will enhance rehabilitation outcomes.

Why it matters

Potential benefit: If successful, this study could significantly improve recovery outcomes for patients with acquired muscle weakness due to critical illness.

How similar studies have gone: While some studies have explored rehabilitation in ICU-acquired weakness, the specific approach of distinguishing between CIM and CIP in relation to FES is relatively novel.

Who can join: the full rules

Show full inclusion / 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

Where it's running

  • IRCCS Fondazione Don Carlo Gnocchi Onlus
    Milan, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.