Improving walking recovery in patients with muscle weakness from critical illness
Regaining Walking Ability Easier and Better in Critical Illness Polyneuropathy and Myopathy
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06786390 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients diagnosed with tetra/paraparesis of peripheral origin who were independent prior to their illness.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan
- IRCCS Fondazione Don Carlo Gnocchi Onlus — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Tiziana Lencioni
- Email: tlencioni@dongnocchi.it
- Phone: 00390240308547
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.