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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | Fondazione Don Carlo Gnocchi ETS Academic / other |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | February 25, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | March 3, 2025 |
| Trial ID | NCT06786390 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
- Study coordinator: Tiziana Lencioni
- Email: tlencioni@dongnocchi.it
- Phone: 00390240308547
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Observing recovery from weakness after severe respiratory and cardiac failure
This study looks at how people who had severe breathing and heart problems recover from weakness after being in intensive care and on a special life-support machine, to see what helps or hinders their recovery.
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We will try to track muscle strength and size over time in people with sepsis in the ICU using bedside exams, ultrasounds, and electrical tests.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.