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.
Trial summary
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). Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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.
Italy1 site, 1 recruiting
- Recruiting
IRCCS-Fondazione Don Gnocchi
Florence, FI, 50143
Chiara Fanciullacci, 00393937317440, cfanciullacci@dongnocchi.it
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.
Read more
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 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.
- 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.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florence
- Responsible party
- Sponsor
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 25727139Cecatto 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 24800715Peckham 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 16004574Intiso 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 28417610Hakiki 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07130929
- Acronym / sponsor ID
- RISE / RISE
- Conditions
- Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Acquired Brain Injury (Including Stroke)
- Keywords
- stroke, Intensive Care Unit (ICU) acquired weakness (ICU - AW), Functional Electrical Stimulation, FES, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- University of Florence
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 23 Sep 2026 (estimated)
- Study completion
- 23 Mar 2027 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm in treatment with conventional physiotherapy plus FES | Experimental | Other: Functional Electrical Stimulation |
| Arm in treatment with only conventional physiotherapy | Active comparator | Other: Conventional physiotherapyconventional physiotherapy in an equivalent additional session (without FES). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Electrical StimulationPhysiotherapy 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. | Other | Arm in treatment with conventional physiotherapy plus FES |
| Conventional physiotherapyConventional 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. | Other | Arm in treatment with only conventional physiotherapy |
Primary outcome
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).
7 secondary outcomes
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).
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).
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).
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).
Change in the parameters recorded during the neurophysiological examination using electromyography.
Time frame: From enrollment to the end of treatment at 5 weeks (T1).
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
Time frame: From enrollment to the end of treatment at 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Background: PubMed 25727139Wong 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.
- Background: PubMed 24800715Cecatto 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.
- Background: PubMed 16004574Peckham 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.
- Background: PubMed 28417610Intiso 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.
- Background: PubMed 32740902Hakiki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bahia Hakiki (00390557393906, bhakiki@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07130929, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.