Functional electrical stimulation plus physiotherapy for severe post-stroke ICU-acquired weakness

Is this trial a fit for you?

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

What this trial studies

This pilot enrolls a small group of adults with severe acquired brain injury from ischemic or hemorrhagic stroke who have a clinical and neurophysiological diagnosis of ICU-acquired weakness. Participants receive conventional physiotherapy sessions augmented by surface functional electrical stimulation (FES) applied to target muscles while they actively perform motor tasks under physiotherapist supervision. The combined approach aims to promote neuroplasticity and muscle reactivation by pairing repetitive, task-oriented movement with timed electrical stimulation. Outcomes will focus on changes in muscle strength, motor function, and relevant neurophysiological measures over the treatment period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of ischemic or hemorrhagic vascular GCA involving unilateral motor deficit \< 3 months;
* Premorbid Modified Rankin Scale \<2;
* Age \>18 years and \<80 years;
* Level of Cognitive Functioning \> 4 for active participation in treatment.
* MRC total sum score \<= 48 (range 0 -60) for clinical suspicion of ICU-AW
* Clinical diagnosis of tetra/paraparesis of peripheral origin confirmed by neurophysiological examination;
* Signature of informed consent by the patient or, if incapacitated, by their legal representative.

Exclusion Criteria:

* Clinical cardio-respiratory or internal instability such as to prevent treatment;
* History of previous comorbidity for ICU-AW;
* Previous known chronic neuropathy;
* Severe coagulopathy;
* Skin integrity problems at the interface surfaces with the electrostimulator;
* Epilepsy not controlled by medication;
* Presence of implanted electronic devices;
* Pregnancy or breastfeeding;
* Severe spasticity with a score of \>3 on the modified Ashworth scale;
* Treatment with botulinum toxin;
* Recent malignant neoplasm;
* Conditions that put you at risk for neuropathies, e.g., history of diabetes mellitus, renal failure, hepatic failure, vitamin deficiencies, chronic alcoholism, vasculitis, previous use of neurotoxic drugs.

Where it's running

• IRCCS-Fondazione Don Gnocchi
  Florence, Fi, Italy Recruiting

Study contacts

• Study coordinator: Bahia Hakiki
• Email: bhakiki@dongnocchi.it
• Phone: 00390557393906

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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.