Functional Electrical Stimulation to Treat Critical Neuromyopathy After Severe Stroke: a Pilot Study.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-23

Study Completion Date

2027-03-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Intensive Care Unit (ICU) Acquired Weakness (ICU - AW) Acquired Brain Injury (Including Stroke)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Arm in treatment with conventional physiotherapy plus FES

Group Type EXPERIMENTAL

Functional Electrical Stimulation

Intervention Type OTHER

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.

Arm in treatment with only conventional physiotherapy

conventional physiotherapy in an equivalent additional session (without FES).

Group Type ACTIVE_COMPARATOR

Conventional physiotherapy

Intervention Type OTHER

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.

Interventions

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Functional Electrical Stimulation

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.

Intervention Type OTHER

Conventional physiotherapy

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No