Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)RISENCT07130929

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

A study testing Functional Electrical Stimulation and Conventional physiotherapy in people with Intensive Care Unit (ICU) Acquired Weakness (ICU - AW) and Acquired Brain Injury (Including Stroke), run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Acquired Brain Injury (Including Stroke)
What is being tested?: Functional Electrical Stimulation and Conventional physiotherapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteItaly
Study dates: 23 Sep 2025to 23 Mar 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bahia Hakiki contact

00390557393906

bhakiki@dongnocchi.it

Italy1 site, 1 recruiting

IRCCS-Fondazione Don Gnocchi
Florence, FI, 50143
Chiara Fanciullacci, 00393937317440, cfanciullacci@dongnocchi.it
Recruiting

Other trials in Italy

About this study

Official 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

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.

Conditions: Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Acquired Brain Injury (Including Stroke)
Being tested: Functional Electrical Stimulation, Conventional physiotherapy
Keywords: stroke, Intensive Care Unit (ICU) acquired weakness (ICU - AW), Functional Electrical Stimulation, FES, Rehabilitation
Medical subject headings: Brain Injuries, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Functional Electrical StimulationOther
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 physiotherapyOther
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.

Study groups in NCT07130929
Study group	Role	What they receive
Arm in treatment with conventional physiotherapy plus FES	Experimental	Not described Receives: Other: Functional Electrical Stimulation
Arm in treatment with only conventional physiotherapy	Active comparator	conventional physiotherapy in an equivalent additional session (without FES). Receives: Other: Conventional physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in lower limb neuromyopathy assessed blindly compared to the treatment/control arm at the clinical level using the Medical Research Council (MRC) scale.
Measured: 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 (7)

Change in the units of the scale "Fugl-Meyer scale for lower limbs".
Measured: From enrollment to the end of treatment at 5 weeks (T1) and from enrollment to the follow-up at 12 weeks(T2).
Change in the units of the scale "the Short Physical Performance Battery (SPPB) scale".
Measured: 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).
Change in the degrees of the active range of motion of the main joints of the lower limbs (hip, knee, ankle).
Measured: 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).
Change in the degrees of passive range of motion of the main joints of the lower limbs (hip, knee, ankle).
Measured: 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).
Change in the parameters recorded during the neurophysiological examination using electromyography.
Measured: From enrollment to the end of treatment at 5 weeks (T1).
Change in the parameters recorded during ultrasound examination
Change in the parameters recorded during ultrasound examination of the transverse diameter of the rectus femoris.
Measured: From enrollment to the end of treatment at 5 weeks (T1).
Change in the parameters recorded during ultrasound examination
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.
Measured: From enrollment to the end of treatment at 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 202523 Mar 2027

First posted19 Aug 2025
Study start23 Sep 2025
Primary completion23 Sep 2026 (estimated)
Study completion23 Mar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07130929
Sponsor's protocol ID: RISE
Acronym: RISE
Status last verified: Oct 2025
First submitted: 6 Aug 2025
Last updated: 11 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Wong JN, Olson JL, Morhart MJ, Chan KM. Electrical stimulation enhances sensory recovery: a randomized controlled trial. Ann Neurol. 2015 Jun;77(6):996-1006. doi: 10.1002/ana.24397. Epub 2015 May 4.
PubMed 25727139
Cecatto RB, Maximino JR, Chadi G. Motor recovery and cortical plasticity after functional electrical stimulation in a rat model of focal stroke. Am J Phys Med Rehabil. 2014 Sep;93(9):791-800. doi: 10.1097/PHM.0000000000000104.
PubMed 24800715
Peckham PH, Knutson JS. Functional electrical stimulation for neuromuscular applications. Annu Rev Biomed Eng. 2005;7:327-60. doi: 10.1146/annurev.bioeng.6.040803.140103.
PubMed 16004574
Intiso D, DI Rienzo F, Fontana A, Tolfa M, Bartolo M, Copetti M. Functional outcome of critical illness polyneuropathy in patients affected by severe brain injury. Eur J Phys Rehabil Med. 2017 Dec;53(6):910-919. doi: 10.23736/S1973-9087.17.04595-6. Epub 2017 Apr 14.
PubMed 28417610
Hakiki B, Draghi F, Scarpino M, Portaccio E, Romoli A, Mannini A, Atzori T, Lolli F, Macchi C, Grippo A. Critical illness polyneuromyopathy: Functional impact after severe acquired brain injuries. Acta Neurol Scand. 2020 Dec;142(6):574-584. doi: 10.1111/ane.13324. Epub 2020 Aug 31.
PubMed 32740902

Interested in taking part?

Bahia Hakiki

00390557393906

bhakiki@dongnocchi.it

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingObservational study
Functional Assessment in Critically Ill Patients
Intensive Care Unit Acquired Weakness, Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)
Not yet recruitingObservational study
The NRC Dataset. Developing a Minimum Dataset for Multidisciplinary Rehabilitation: a Modified E-Delphi Study
Pain, Traumatic Brain Injury

All Intensive Care Unit (ICU) Acquired Weakness (ICU - AW) trials