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NCT Number: NCT07130929

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS-Fondazione Don Gnocchi

Florence, FI, 50143, Italy

Location status: Recruiting

Location contact

Chiara Fanciullacci

CONTACT

[email protected]

00393937317440

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional Electrical Stimulation

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.

Conventional Physiotherapy

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.

Primary outcomes

  1. Change in lower limb neuromyopathy assessed blindly compared to the treatment/control arm at the clinical level using the Medical Research Council (MRC) scale.

    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).

Secondary outcomes

  1. Change in the units of the scale "Fugl-Meyer scale for lower limbs".

    Time frame: From enrollment to the end of treatment at 5 weeks (T1) and from enrollment to the follow-up at 12 weeks(T2).

  2. Change in the units of the scale "the Short Physical Performance Battery (SPPB) scale".

    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).

  3. Change in the degrees of the active range of motion of the main joints of the lower limbs (hip, knee, ankle).

    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).

  4. Change in the degrees of passive range of motion of the main joints of the lower limbs (hip, knee, ankle).

    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).

  5. Change in the parameters recorded during the neurophysiological examination using electromyography.

    Time frame: From enrollment to the end of treatment at 5 weeks (T1).

  6. Change in the parameters recorded during ultrasound examination

    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.

  7. Change in the parameters recorded during ultrasound examination

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bahia Hakiki

CONTACT

[email protected]

00390557393906

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • University of Florence

Registry information

Official study 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

Acronym: RISE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 19, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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