Chronic StrokeNCT05240716
Functional Electrical Stimulation on Tibial Nerve in Stroke Patients.
A study testing FES program in people with Chronic Stroke, run by University of Gran Rosario at 1 site in Argentina.
Trial summary
Hemiparetic gait is one of the most common consequences after stroke. This impairment has a detrimental effects on the patients lies, limiting their social participation. Previous studies have shown that there is a direct relationship between triceps surae activation and gait speed in stroke patients, that is, higher… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- FES program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteArgentina
- Study dates
- 21 Mar 2022to 10 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ranging between 18 to 70 years.
- Subjects with chronic ischemic stroke (more than 12 months of evolution)
- Ability to walk 20 mts. without third-party assistance.
- Hemiparesis with weakness and spasticity in the triceps surae.
Who cannot join
- Previous injury on paretic lower limb
- Soft tissue or joint retraction limiting ankle range of motion (ROM)
- Severe peripheral nervous system compromise
- Electronic devices that could be altered by the use of FES (e.g. cardiac pacemaker)
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Department of Physical Therapy, Neurofunctional Research Unit - UIN, University Center for Assistance, Teaching and Research - CUADI University of Gran Rosario
Rosario, Santa Fe Province, 2000
About this study
Official title: Assessing the Usefulness of Functional Electrical Stimulation Program on Tibial Nerve for Rehabilitation of Chronic Stroke Patients
Hemiparetic gait is one of the most common consequences after stroke. This impairment has a detrimental effects on the patients lies, limiting their social participation. Previous studies have shown that there is a direct relationship between triceps surae activation and gait speed in stroke patients, that is, higher triceps surae muscle activation are correspond to greater gait speed. Then, it can be hypothesized that therapies focused in strengthening the triceps surae also improves the patient gait. It has been shown that Functional Electrical Stimulation (FES) can improve triceps surae activation when applied on healthy subjects. However, it has not been yet explored in chronic stroke patients. Therefore, the aim of this study is to assess whether a FES program over tibial nerve contributes to the rehabilitation of the gait in chronic hemiparetic stroke patients. This study present a prospective interventional design, based on non-probabilistic sampling for convenience, and comprising a total of 15 volunteers with ischemic stroke of both genders and aged between 18 and 70 years old. Volunteers will be recruited from hospitals and private rehabilitation centres, and must be currently engaged in a conventional rehabilitation program. The study will consist of twenty-four sessions, with a frequency of three sessions per week.
- Conditions
- Chronic Stroke
- Being tested
- FES program
- Keywords
- Functional electrical stimulation, Tibial Nerve stimulation, Chronic stroke, Hemiparetic gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES programOther
8 weeks intervention. 3 sessions per week. Previous to the intervention, volunteers will familiarize with the electrical stimulation by receiving three trials of the stimuli. Electrical current intensity will be set for each volunteers, with the capacity of generating a muscle contraction without inducing discomfort in the volunteer. During the FES program, patient in standing position will perform a step, while electrical current stimulation will be applied to the skin over the tibial nerve on the contralateral of the stimulation side. The FES will be delivered during the paretic plantarflexor activation according to the gait cycle. The FES session will consist of 5-minutes stimulation blocks with breaks between blocks (total session time: 30 minutes). For safety reasons, a physical therapist will supervise all the FES intervention sessions.
| Study group | Role | What they receive |
|---|---|---|
| FES program | Experimental | Not described Receives: Other: FES program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait velocity
A 10 metres walk test will be performed to asses gait velocity.
Measured: Baseline and week 8 (after 24 sessions of intervention)
Secondary outcomes (12)
Change in maximal isometric strength
To assess maximal isometric strength of dorsiflexor muscles, volunteers will performed 3 maximum repetitions of 6 seconds of isometric dorsiflexion. Force will be quantified using a load cell (maximum tension-compression = 200 Kgf, accuracy 0.1 Kgf, maximum measurement error = 0.33%; Equipo Biomédico Miotec ™, Porto Alegre, RS, Brazil), and this cell will be placed on a rigid surface and strapped to the volunteer's foot. In addition, the recorded force will be synchronised with the electromyograph to evaluate the isometric tensile strength. During this assessment, volunteers will be in supine position with the assessed lower limb extended on the stretcher.
Measured: Baseline, immediately after first session and week 8 (after 24 sessions of intervention)
Change in Spasticity
The Modified Ashworth scale will be performed with volunteers in supine position, and the assessed lower limb extended on the stretcher. Passive stretching of the triceps surae will be applied at a constant speed from the position of maximum plantarflexion to the maximum possible dorsiflexion. Scores range from 0 to 4. A score of 0 indicates no resistance, and 4 indicates rigidity.
Measured: Baseline, immediately after first session and week 8 (after 24 sessions of intervention)
Change in muscle activity
Surface electromyography (sEMG) will be recorded to assess activation of the tibialis anterior muscle. Four EMG channels will be acquired using commercial device (Miotec Suite ™, Biomedical Equipment, Porto Alegre, RS, Brazil). The electrodes (Ag/AgCl, with a centre-to-centre distance of 2 cm) will be align parallel to the muscle fibres of the tibialis anterior muscle, according to the recommendations of the International Society of Electrophysiology and Kinesiology (ISEK http://www.isek-online.org). A reference electrode will be placed on the lateral malleolus. Prior to electrode placement, the skin will be shaved and cleaned with cotton and 70% alcohol, in order to minimize skin impedance. The electromyographic recordings will be performed in the supine position, with the assessed leg extended and the opposite leg flexed at 70º with plantar support (measured by a goniometer).
Measured: Baseline, immediately after first session and week 8 (after 24 sessions of intervention)
Change in cortical electrical activity
Electroencephalography (EEG) will be recorded during active movement of the affected lower limb using a BIOAMP electroencephalography instrument (UNER, Oro Verde, Entre Ríos, Argentina), using a cap with 15 electrodes distributed according to the international 10-20 system. The volunteer will be seated with feet fully supported on a surface. During the recordings, the volunteers will be instructed to achieve relaxation to measure the resting state, and then they will be asked to perform an active movement of the affected lower limb.
Measured: Baseline and week 8 (after 24 sessions of intervention)
Changes in cadence
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Measured: Baseline and week 8 (after 24 sessions of intervention)
Changes in stride length
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Measured: Baseline and week 8 (after 24 sessions of intervention)
Change in stride time
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Measured: Baseline and week 8 (after 24 sessions of intervention)
Change in swing phase
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Measured: Baseline and week 8 (after 24 sessions of intervention)
Change in stance phase
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Measured: Baseline and week 8 (after 24 sessions of intervention)
Change in double support
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Measured: Baseline and week 8 (after 24 sessions of intervention)
Change in stride velocity
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Measured: Baseline and week 8 (after 24 sessions of intervention)
Change in spasticity
Modified Tardieu scale will be performed with volunteers in supine position, and the assessed lower limb extended on the stretcher. Passive stretching of the triceps surae will be applied with faster speed and then with slow speed from the position of maximum plantarflexion to the maximum possible dorsiflexion to determine the values of R1 (the angle of muscle reaction with fast speed stretch) and R2 (degrees of dorsiflexion reached with slow speed stretch).
Measured: Baseline, immediately after first session and week 8 (after 24 sessions of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start21 Mar 2022
- Primary completion10 Apr 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gran Rosario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melisa Taborda, University of Gran Rosario
- Investigators
- Leonardo Intelangelo, MSc, Study director, Universidad del Gran Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240716
- Sponsor's protocol ID
- FES on TN in stroke
- Status last verified
- Jun 2026
- First submitted
- 31 Jan 2022
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Usefulness of Functional Electrical Stimulation Program on Tibial Nerve for Rehabilitation of Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05240716
- Acronym / sponsor ID
- FES on TN in stroke
- Conditions
- Chronic Stroke
- Keywords
- Functional electrical stimulation, Tibial Nerve stimulation, Chronic stroke, Hemiparetic gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Gran RosarioUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 15 Feb 2022 (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.
Hemiparetic gait is one of the most common consequences after stroke. This impairment has a detrimental effects on the patients lies, limiting their social participation. Previous studies have shown that there is a direct relationship between triceps surae activation and gait speed in stroke patients, that is, higher triceps surae muscle activation are correspond to greater gait speed. Then, it can be hypothesized that therapies focused in strengthening the triceps surae also improves the patient gait. It has been shown that Functional Electrical Stimulation (FES) can improve triceps surae activation when applied on healthy subjects. However, it has not been yet explored in chronic stroke patients. Therefore, the aim of this study is to assess whether a FES program over tibial nerve contributes to the rehabilitation of the gait in chronic hemiparetic stroke patients. This study present a prospective interventional design, based on non-probabilistic sampling for convenience, and comprising a total of 15 volunteers with ischemic stroke of both genders and aged between 18 and 70 years old. Volunteers will be recruited from hospitals and private rehabilitation centres, and must be currently engaged in a conventional rehabilitation program. The study will consist of twenty-four sessions, with a frequency of three sessions per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FES program | Experimental | Other: FES program |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ranging between 18 to 70 years.
- Subjects with chronic ischemic stroke (more than 12 months of evolution)
- Ability to walk 20 mts. without third-party assistance.
- Hemiparesis with weakness and spasticity in the triceps surae.
Key exclusion criteria (4 listed)
- Previous injury on paretic lower limb
- Soft tissue or joint retraction limiting ankle range of motion (ROM)
- Severe peripheral nervous system compromise
- Electronic devices that could be altered by the use of FES (e.g. cardiac pacemaker)
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 |
|---|---|---|
| FES program8 weeks intervention. 3 sessions per week. Previous to the intervention, volunteers will familiarize with the electrical stimulation by receiving three trials of the stimuli. Electrical current intensity will be set for each volunteers, with the capacity of generating a muscle contraction without inducing discomfort in the volunteer. During the FES program, patient in standing position will perform a step, while electrical current stimulation will be applied to the skin over the tibial nerve on the contralateral of the stimulation side. The FES will be delivered during the paretic plantarflexor activation according to the gait cycle. The FES session will consist of 5-minutes stimulation blocks with breaks between blocks (total session time: 30 minutes). For safety reasons, a physical therapist will supervise all the FES intervention sessions. | Other | FES program |
Primary outcome
Change in gait velocity
Time frame: Baseline and week 8 (after 24 sessions of intervention)
A 10 metres walk test will be performed to asses gait velocity.
12 secondary outcomes
Change in maximal isometric strength
Time frame: Baseline, immediately after first session and week 8 (after 24 sessions of intervention)
Change in Spasticity
Time frame: Baseline, immediately after first session and week 8 (after 24 sessions of intervention)
Change in muscle activity
Time frame: Baseline, immediately after first session and week 8 (after 24 sessions of intervention)
Change in cortical electrical activity
Time frame: Baseline and week 8 (after 24 sessions of intervention)
Changes in cadence
Time frame: Baseline and week 8 (after 24 sessions of intervention)
Changes in stride length
Time frame: Baseline and week 8 (after 24 sessions of intervention)
Change in stride time
Time frame: Baseline and week 8 (after 24 sessions of intervention)
Change in swing phase
Time frame: Baseline and week 8 (after 24 sessions of intervention)
Change in stance phase
Time frame: Baseline and week 8 (after 24 sessions of intervention)
Change in double support
Time frame: Baseline and week 8 (after 24 sessions of intervention)
Change in stride velocity
Time frame: Baseline and week 8 (after 24 sessions of intervention)
Change in spasticity
Time frame: Baseline, immediately after first session and week 8 (after 24 sessions of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
Related trials for Chronic Stroke
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruiting
Lumbar Spinal Manipulation in Stroke
Stroke
Recruiting
Effect of Lower Limb Proprioceptive Neuromuscular Facilitation Combined With Core Stability Training Versus Proprioceptive Neuromuscular Facilitation Alone on Balance and Functional Mobility in Chronic Stroke Survivors
Stroke
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. This study is not recruiting at the moment.
Leonardo Intelangelo, MSc study director
Universidad del Gran Rosario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES program in people with Chronic Stroke, run by University of Gran Rosario at 1 site in Argentina.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 11 Jun 2026. 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 Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gait velocity (time frame: Baseline and week 8 (after 24 sessions of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2026.