Functional 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/28417610/Actively Recruiting
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-12-11
24
Participants Needed
1
Research Sites
25 weeks
Total Duration
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
Functional Electrical Stimulation to Treat Critical Neuromyopathy After Severe Stroke: a Pilot Study.
B
Bahia Hakiki
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Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
University of Florence
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/16004574/Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
University of Florence
Collaborating Sponsor