Functional Electrical Stimulation on Tibial Nerve in Stroke Patients.

June 10, 2026 updated by: Melisa Taborda, University of Gran Rosario

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Argentina
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Department of Physical Therapy, Neurofunctional Research Unit - UIN, University Center for Assistance, Teaching and Research - CUADI University of Gran Rosario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FES program
Other: FES program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and week 8 (after 24 sessions of intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in maximal isometric strength
Time Frame: Baseline, immediately after first session and week 8 (after 24 sessions of intervention)
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.
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)
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.
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)
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).
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)
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.
Baseline and week 8 (after 24 sessions of intervention)
Changes in cadence
Time Frame: Baseline and week 8 (after 24 sessions of intervention)
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.
Baseline and week 8 (after 24 sessions of intervention)
Changes in stride length
Time Frame: Baseline and week 8 (after 24 sessions of intervention)
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.
Baseline and week 8 (after 24 sessions of intervention)
Change in stride time
Time Frame: Baseline and week 8 (after 24 sessions of intervention)
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.
Baseline and week 8 (after 24 sessions of intervention)
Change in swing phase
Time Frame: Baseline and week 8 (after 24 sessions of intervention)
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.
Baseline and week 8 (after 24 sessions of intervention)
Change in stance phase
Time Frame: Baseline and week 8 (after 24 sessions of intervention)
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.
Baseline and week 8 (after 24 sessions of intervention)
Change in double support
Time Frame: Baseline and week 8 (after 24 sessions of intervention)
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.
Baseline and week 8 (after 24 sessions of intervention)
Change in stride velocity
Time Frame: Baseline and week 8 (after 24 sessions of intervention)
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.
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)
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).
Baseline, immediately after first session and week 8 (after 24 sessions of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Gran Rosario

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Leonardo Intelangelo, MSc, Universidad del Gran Rosario

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FES on TN in stroke

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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