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

Intensive Rehabilitation by Functional Electrical Stimulation for the Treatment of Critical Neuromyopathy in Patients With Severe Stroke Admitted to the Highly Specialized Intensive Rehabilitation Unit: a Pilot Study

This pilot will try using functional electrical stimulation together with physiotherapy to help adults with recent severe stroke who developed ICU-acquired weakness regain strength and movement.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Fondazione Don Carlo Gnocchi Onlus (other)
• Locations: 1 site (Florence, FI)
• Trial ID: NCT07130929 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults 18–80 with ischemic or hemorrhagic stroke within three months, premorbid mRS <2, cognitive ability for active participation, clinical and neurophysiological confirmation of ICU‑AW with MRC sum ≤48, and no contraindications to FES.

Not a fit: Patients with hemodynamic or respiratory instability, uncontrolled epilepsy, implanted electronic devices, severe spasticity (>3), chronic neuropathy, skin integrity problems at electrode sites, pregnancy or breastfeeding, or other listed exclusions are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could speed recovery of muscle strength and improve functional mobility after severe stroke-related ICU-acquired weakness.

How similar studies have performed: FES has shown positive signals for strength and function in other post-stroke and ICU rehabilitation programs, but high-quality evidence specifically in severe ICU‑AW is limited and this application remains exploratory.

Eligibility criteria

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 this trial is running

Florence, FI

• IRCCS-Fondazione Don Gnocchi — Florence, FI, Italy (RECRUITING)

Study contacts

• Study coordinator: Bahia Hakiki

Conditions: Intensive Care Unit Acquired Weakness, Acquired Brain Injury, stroke, Intensive Care Unit acquired weakness, Functional Electrical Stimulation, FES, Rehabilitation