IRCCS-Fondazione Don Gnocchi
Florence, FI, 50143, Italy
Location status: Recruiting
NCT Number: NCT07130929
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.
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Florence, FI, 50143, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Physiotherapy exercises, selected from a group of active flexion-extension exercises, cycle ergometer, sit-to-stand exercises and a preparatory exercise for the gait pattern with hip flexion and subsequent loading on the lower limb, associated with functional electrical stimulation.
Conventional physiotherapy exercises, selected from a group of active flexion-extension exercises, cycle ergometer, sit-to-stand exercises and a preparatory exercise for the gait pattern with hip flexion and subsequent loading on the lower limb.
Time frame: From enrollment to the end of treatment at 5 weeks from T0 (T1) and from enrollment to the follow-up at 12 weeks from T0(T2).
Time frame: From enrollment to the end of treatment at 5 weeks (T1) and from enrollment to the follow-up at 12 weeks(T2).
Time frame: From enrollment to the end of treatment at 5 weeks from T0 (T1) and from enrollment to the follow-up at 12 weeks from T0(T2).
Time frame: From enrollment to the end of treatment at 5 weeks from T0 (T1) and from enrollment to the follow-up at 12 weeks from T0(T2).
Time frame: From enrollment to the end of treatment at 5 weeks from T0 (T1) and from enrollment to the follow-up at 12 weeks from T0(T2).
Time frame: From enrollment to the end of treatment at 5 weeks (T1).
Time frame: From enrollment to the end of treatment at 5 weeks (T1).
Change in the parameters recorded during ultrasound examination of the transverse diameter of the rectus femoris.
Time frame: From enrollment to the end of treatment at 5 weeks
Change in the difference between the distance from the skin plane and the deep layer of the rectus femoris recorded with the muscle at rest and during contraction, recorded using M-mode ultrasound.
Contact information is provided by the study sponsor or research team.
Fondazione Don Carlo Gnocchi ETS
Other
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
Acronym: RISE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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