Electrical Stimulation With Exercise for Weakness After Severe Stroke
Tests electrical stimulation with physiotherapy in adults with severe stroke and weakness.
Key facts
- Who runs it
- Fondazione Don Carlo Gnocchi ETS
- Where
- Florence, ItalySee the site
- Trial code
- Registry title
- Functional Electrical Stimulation to Treat Critical Neuromyopathy After Severe Stroke: a Pilot Study.
- Status
- Recruiting
- People taking part
- 24 people, planned
- Started
- 23 Sept 2025
- Expected to end
- 23 Mar 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Functional Electrical Stimulation
- Conventional physiotherapy
- Record updated
- 11 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a severe stroke who have also developed muscle and nerve weakness after intensive care. It tests physiotherapy with or without electrical muscle stimulation.
- Age
- Over 18 and under 80 years
- Sex
- All sexes can join
- Disease stage
- Stroke from a blocked or bleeding blood vessel, with weakness on one side for less than 3 months. Clinical suspicion of ICU-acquired weakness (MRC total sum score 48 or lower), confirmed by nerve tests.
- Earlier treatment
- No botulinum toxin treatment.
- Biomarker or test result
- Weakness of the arms and legs from the nerves outside the brain, confirmed by a neurophysiological examination.
Main reasons for not taking part
- Heart, lung or other medical instability that prevents treatment
- Implanted electronic devices
- Known chronic nerve disease, or risks such as diabetes, kidney failure or liver failure
- Epilepsy not controlled by medication
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- History of previous comorbidity for ICU-AW
- Previous known chronic neuropathy
- Treatment with botulinum toxin
- 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
- Epilepsy not controlled by medication
- Recent malignant neoplasm
- Clinical cardio-respiratory or internal instability such as to prevent treatment
- Severe coagulopathy
- Skin integrity problems at the interface surfaces with the electrostimulator
- Presence of implanted electronic devices
- Pregnancy or breastfeeding
- Severe spasticity with a score of >3 on the modified Ashworth scale
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Italy
- IRCCS-Fondazione Don GnocchiFlorence, ItalyContact: Chiara FanciullacciTaking people
About the trial
What the trial wants to find out
This study aims to evaluate the effectiveness of physiotherapy treatment combined with functional electrical stimulation (FES) in a small group of patients with severe acquired brain injury (SABI) of vascular origin and with a clinical and instrumental diagnosis of "Intensive Care Unit-Acquired Weakness" (ICU-AW). Functional electrical stimulation is a technology that uses electrical impulses, generated by an external device, to reactivate the neuromuscular system through electrodes applied to the skin. In functional electrical stimulation, this process is integrated into physiotherapy sessions, with the active involvement of the patient, through the performance of exercises with the assistance and supervision of the physiotherapist. The rationale behind this is to stimulate neuroplasticity processes by facilitating movement through the application of electrical stimuli and the active participation of the patient in performing a motor task, in an attempt to promote improvement in an impaired function.
Read full original descriptionShow less
In particular, the objectives that will be pursued are: improvement of lower limb neuromyopathy assessed clinically using the Medical Research Council (MRC) scale, the Fugl-Meyer scale for lower limbs, the Short Physical Performance Battery (SPPB) scale, the assessment of active and passive Range Of Motion (ROM) of the main joints of the lower limb (hip, knee, ankle) and measured instrumentally by neurophysiological examination and ultrasound examination.
After randomization, patients in the control arm will be treated with physiotherapy and speech therapy sessions as per the conventional protocol, and an additional 15 physiotherapy sessions lasting 60 minutes over a period of 5 weeks. Alternatively, patients in the experimental group will receive, in addition to conventional rehabilitation treatment, a treatment consisting of 15 physiotherapy sessions combined with FES lasting 60 minutes over a period of 5 weeks.
At the end of the treatment period, baseline characteristics and clinical and instrumental outcome variables will be compared between the two groups using the chi-square test for dichotomous and categorical variables and the t-test for independent samples or the Mann-Whitney U test for continuous variables, depending on whether or not they are normally distributed. In all analyses, a p-value <0.05 will be considered significant.
The 2 groups in the trial
- Arm in treatment with conventional physiotherapy plus FESTreatment being tested
Treatment: Functional Electrical Stimulation
- Arm in treatment with only conventional physiotherapyExisting treatment, for comparison
conventional physiotherapy in an equivalent additional session (without FES).
Treatment: Conventional physiotherapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Electrical Stimulation With Exercise for Weakness After Severe StrokeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07130929, who can take part
- Record updated
- 11 December 2025