Electrical stimulation enhances sensory recovery: a randomized controlled trial.
Joshua N Wong, Jaret L Olson, Michael J Morhart...
https://pubmed.ncbi.nlm.nih.gov/25727139Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07130929
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
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-12-11
24
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
F
Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
U
University of Florence
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of combining physiotherapy with functional electrical stimulation (FES) for patients who have severe acquired brain injury (SABI) caused by vascular events and diagnosed with Intensive Care Unit-Acquired Weakness (ICU-AW). This pilot study focuses on improving lower limb neuromyopathy and motor function through neuroplasticity stimulation by integrating electrical impulses into physiotherapy exercises. Participants are randomly assigned to one of two groups. One group receives conventional physiotherapy and speech therapy with an additional 15 physiotherapy sessions over 5 weeks. The experimental group receives the same conventional treatment plus 15 physiotherapy sessions combined with FES, where electrical stimulation is applied through skin electrodes during active exercises. Both treatments last 60 minutes per session. Throughout the study, researchers assess improvements using clinical scales like the Medical Research Council (MRC) scale, Fugl-Meyer scale, and Short Physical Performance Battery (SPPB), as well as measurements of joint range of motion and neurophysiological and ultrasound examinations. Outcomes are evaluated at the end of treatment (5 weeks) and at a 12-week follow-up. Safety and progress are monitored to compare the effects between the two groups.
CONDITIONS
Brief Title
Functional Electrical Stimulation to Treat Critical Neuromyopathy After Severe Stroke: a Pilot Study.
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of ischemic or hemorrhagic vascular stroke involving unilateral motor deficit less than 3 months
- Premorbid Modified Rankin Scale less than 2
- Age over 18 years and under 80 years
- Level of Cognitive Functioning greater than 4 for active participation in treatment
- Medical Research Council total sum score 48 or less (range 0-60) indicating clinical suspicion of ICU-Acquired Weakness
- Clinical diagnosis of tetra- or paraparesis of peripheral origin confirmed by neurophysiological examination
- Signed informed consent by the patient or legal representative
You will not qualify if you...
- Clinical cardio-respiratory or internal instability preventing treatment
- History of previous comorbidity for ICU-Acquired Weakness
- Known chronic neuropathy
- Severe coagulopathy
- Skin integrity problems at electrode application sites
- Epilepsy not controlled by medication
- Presence of implanted electronic devices
- Pregnancy or breastfeeding
- Severe spasticity with a score greater than 3 on the modified Ashworth scale
- Treatment with botulinum toxin
- Recent malignant neoplasm
- Conditions increasing risk for neuropathies such as diabetes, renal or hepatic failure, vitamin deficiencies, chronic alcoholism, vasculitis, or previous neurotoxic drug use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5 weeks
Participants receive either conventional physiotherapy combined with functional electrical stimulation or conventional physiotherapy alone to improve neuromyopathy after severe stroke.
Weekly visits during treatment
Follow-up
Duration - 7 weeks
Participants are assessed to evaluate longer-term effects of the treatment on neuromyopathy and physical function.
1 follow-up visit at 12 weeks from treatment start
Trial Site Locations
Total: 1 location
1
IRCCS-Fondazione Don Gnocchi
Florence, FI, Italy, 50143
Actively Recruiting
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Research Team
B
Bahia Hakiki
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Motor recovery and cortical plasticity after functional electrical stimulation in a rat model of focal stroke.
Rebeca Boltes Cecatto, Jessica Ruivo Maximino, Gerson Chadi
https://pubmed.ncbi.nlm.nih.gov/24800715Functional electrical stimulation for neuromuscular applications.
P Hunter Peckham, Jayme S Knutson
https://pubmed.ncbi.nlm.nih.gov/16004574Functional outcome of critical illness polyneuropathy in patients affected by severe brain injury.
Domenico Intiso, Filomena DI Rienzo, Andrea Fontana...
https://pubmed.ncbi.nlm.nih.gov/28417610Critical illness polyneuromyopathy: Functional impact after severe acquired brain injuries.
Bahia Hakiki, Francesca Draghi, Maenia Scarpino...
https://pubmed.ncbi.nlm.nih.gov/32740902