Post-stroke HemiparesisNCT07189819
Innovative Closed-loop Functional Electrical Stimulation Control System for Augmenting Post-stroke Gait
A study testing Conventional Functional Electrical Stimulation (FES) in people with Post-stroke Hemiparesis, run by Emory University at 1 site in United States.
Trial summary
This study will compare the performance of a novel data-driven model-predictive controller (MPC) based functional electrical stimulation (FES) system versus a conventional FES system for footdrop correction during treadmill and overground walking tasks in people post-stroke. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Post-stroke Hemiparesis
- What is being tested?
- Conventional Functional Electrical Stimulation (FES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2026to 31 Jan 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >6 months since stroke
- cortical or subcortical stroke
- able to walk 10-meters with or without an assistive device
- sufficient cardiovascular health and ankle stability to walk on treadmill without ankle orthosis
- passive ankle range of motion to benefit from dorsiflexor FES assistance
- resting heart rate 40-100 bpm
Who cannot join
- cerebellar signs
- score >1 on question 1b (does not know the current month and age) and >0 on question 1c (can not blink eyes and squeeze hands) on NIH Stroke Scale
- inability to communicate with investigators
- neglect/hemianopia
- unexplained dizziness in past 6 months
- sensory loss in paretic leg
- musculoskeletal or medical conditions limiting walking
- neurologic diagnoses other than stroke
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory Rehabilitation Hospital
Atlanta, Georgia, 30322
About this study
This study will compare the performance of a novel data-driven model-predictive controller (MPC) based functional electrical stimulation (FES) system versus a conventional FES system for footdrop correction during treadmill and overground walking tasks in people post-stroke.
Read the detailed description
Functional electrical stimulation (FES) is a common rehabilitation tool that incorporates electrical stimulation timed with a functional task to augment paretic muscle function in people with neuro-pathologies such as stroke and spinal cord injury. The rigor of previous research has established the safety, as well as both neuro-prosthetic and therapeutic effects of FES systems for standing, walking, and grasping. Stroke is the leading cause of disability, and footdrop is a highly prevalent post-stroke gait deficit, leading to insufficient ankle dorsiflexion during the swing phase of gait, and contributing to reduced mobility. FES systems that correct footdrop to improve gait function and reduce fall risk are gaining popularity, with commercial systems such as enhancing translation potential. Despite their promising functional value, accessibility, and positive neuroplasticity effects, current FES systems have some fundamental limitations, which limit their clinical prescription.
The goal of this project is to overcome two major limitations and technical gaps in FES: rapid onset of muscle fatigue during FES and lack of sophisticated closed-loop control of FES intensity. Most existing FES systems do not automatically modulate stimulation intensity in response to muscle fatigue, and may overstimulate the muscles if fixed (open-loop) stimulation or a pure feedback-based stimulation strategy is used to control FES intensity. To address this limitation, the researchers aim to develop and clinically test FES for improving stroke gait using data-driven FES control systems.
Footdrop is a highly prevalent post-stroke gait deficit, leading to insufficient ankle dorsiflexion during the swing phase of gait, and reducing functional mobility. FES, which is an external application of stimulation to generate muscle contractions during a functional motor task, can achieve muscle force demands during standing and walking, and help persons with stroke and spinal cord injury recover mobility. FES for the correction of footdrop is one of the most popular gait applications of FES, which has been shown to improve mobility and reduce falls.
Although FES has positive effects on walking function, elicits active muscle contractions, and enhances corticomotor excitability, FES is not used as commonly as passive orthotics. Most current FES systems incorporate motion sensors to control the timing of FES during the gait cycle (paretic leg swing phase). However, none of these systems provide automatic closed-loop control of FES intensity, so that optimal stimulation can be delivered for each step, preventing over-stimulation, reducing fatigue, and maintaining optimal muscle performance for a greater number of steps. Additionally, rapid onset of muscle fatigue during FES is caused by synchronous, non-selective, repeated recruitment of largely fatigable muscle fibers.
The researchers will implement an innovative model-predictive controller (MPC) combined with real-time ultrasound-based feedback to deliver optimal FES intensities and minimize fatigue.
- Conditions
- Post-stroke Hemiparesis
- Being tested
- Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES), Conventional Functional Electrical Stimulation (FES)
- Keywords
- post-stroke gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES)Device
The model-predictive controller (MPC) determines the timing and intensity of electrical stimulation delivered for FES. MPC combined with real-time ultrasound-based feedback delivers optimal FES intensities and minimizes fatigue. FES is delivered to the ankle dorsiflexor muscles using a commercially available FDA-approved electrical stimulator.
Conventional Functional Electrical Stimulation (FES)Device
For functional electrical stimulation, surface electrodes are placed on the paretic leg on skin overlying the tibialis anterior (TA) muscle, with intensity pre-set to elicit dorsiflexion to neutral against gravity. FES will be delivered to the ankle dorsiflexor muscles using a commercially available FDA-approved electrical stimulator.
| Study group | Role | What they receive |
|---|---|---|
| MPC FES Followed by Conventional FES | Experimental | Post-stroke participants participating in both treadmill and overground walking trials with the novel model-predictive controller (MPC) functional electrical stimulation (FES) system first and with a conventional functional electrical stimulation (FES) system second. Receives: Device: Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES); Device: Conventional Functional Electrical Stimulation (FES) |
| Conventional FES Followed by MPC FES | Experimental | Post-stroke participants participating in both treadmill and overground walking trials with a conventional functional electrical stimulation (FES) system first and the novel model-predictive controller (MPC) functional electrical stimulation (FES) system second. Receives: Device: Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES); Device: Conventional Functional Electrical Stimulation (FES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Safety is assessed as the number of adverse events experienced by study participants.
Measured: Day 1
Count of Risks
Safety is assessed as the count of risks, including falling, discomfort, pain, skin problems, fatigue, and soreness.
Measured: Day 1
Participant Perception of Comfort
Participant perception of comfort is measured on an 10-point Likert scale ranging from 1 to 10, where 10 is the most comfortable.
Measured: Day 1
Participant Perception of Acceptability
Participant perception of acceptability is measured on an 10-point Likert scale ranging from 1 to 10, where 10 is the most acceptable.
Measured: Day 1
Percent of Gait Cycles with Footdrop Correction
Feasibility of the FES control system is assessed as the percentage of gait cycles with footdrop correction. The FES control system is considered effective if greater than 80% of gait cycles have footdrop correction.
Measured: Day 1
Number of Participants Completing Gait Bouts
Feasibility of the FES control system is assessed as the number of participants who are able to complete gait bouts with the MPC FES system. The FES control system is considered effective if greater than 80% of participants are able to complete gait bouts.
Measured: Day 1
Secondary outcomes (3)
Peak Ankle Dorsiflexion Angle During Swing
Gait biomechanics performance is assessed as the peak ankle dorsiflexion angle during swing. The normal range for peak ankle dorsiflexion is 0 to 5 degrees.
Measured: Day 1
Overground Walking Distance
Gait performance is assessed as overground walking distance traveled, in meters, during a 6-minute walk test.
Measured: Day 1
FES Intensity
FES system performance is assessed as FES intensity. FES intensity is measured during a treadmill walking bout. Intensity is measured by milliamps (mA) or millivolts (mV).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start7 Jul 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke HemiparesisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Crossover
- Model description
- Participants are randomized to the order of the test conditions.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Trisha Kesar, Emory University
- Investigators
- Trisha Kesar, PT, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189819
- Sponsor's protocol ID
- STUDY00010102
- Other IDs
- 1R21HD116484, 2025P013785
- Status last verified
- Jul 2026
- First submitted
- 17 Sep 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data for primary dependent variables that underlie the results reported in publications from this study (such as text, tables, appendices) will be made available for sharing with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Closed-loop Functional Electrical Stimulation Control System for Augmenting Post-stroke Gait
- ClinicalTrials.gov ID
- NCT07189819
- Acronym / sponsor ID
- STUDY00010102
- Conditions
- Post-stroke Hemiparesis
- Keywords
- post-stroke gait
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 24 Sep 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 will compare the performance of a novel data-driven model-predictive controller (MPC) based functional electrical stimulation (FES) system versus a conventional FES system for footdrop correction during treadmill and overground walking tasks in people post-stroke.
Detailed description
Functional electrical stimulation (FES) is a common rehabilitation tool that incorporates electrical stimulation timed with a functional task to augment paretic muscle function in people with neuro-pathologies such as stroke and spinal cord injury. The rigor of previous research has established the safety, as well as both neuro-prosthetic and therapeutic effects of FES systems for standing, walking, and grasping. Stroke is the leading cause of disability, and footdrop is a highly prevalent post-stroke gait deficit, leading to insufficient ankle dorsiflexion during the swing phase of gait, and contributing to reduced mobility. FES systems that correct footdrop to improve gait function and reduce fall risk are gaining popularity, with commercial systems such as enhancing translation potential. Despite their promising functional value, accessibility, and positive neuroplasticity effects, current FES systems have some fundamental limitations, which limit their clinical prescription.
The goal of this project is to overcome two major limitations and technical gaps in FES: rapid onset of muscle fatigue during FES and lack of sophisticated closed-loop control of FES intensity. Most existing FES systems do not automatically modulate stimulation intensity in response to muscle fatigue, and may overstimulate the muscles if fixed (open-loop) stimulation or a pure feedback-based stimulation strategy is used to control FES intensity. To address this limitation, the researchers aim to develop and clinically test FES for improving stroke gait using data-driven FES control systems.
Footdrop is a highly prevalent post-stroke gait deficit, leading to insufficient ankle dorsiflexion during the swing phase of gait, and reducing functional mobility. FES, which is an external application of stimulation to generate muscle contractions during a functional motor task, can achieve muscle force demands during standing and walking, and help persons with stroke and spinal cord injury recover mobility. FES for the correction of footdrop is one of the most popular gait applications of FES, which has been shown to improve mobility and reduce falls.
Although FES has positive effects on walking function, elicits active muscle contractions, and enhances corticomotor excitability, FES is not used as commonly as passive orthotics. Most current FES systems incorporate motion sensors to control the timing of FES during the gait cycle (paretic leg swing phase). However, none of these systems provide automatic closed-loop control of FES intensity, so that optimal stimulation can be delivered for each step, preventing over-stimulation, reducing fatigue, and maintaining optimal muscle performance for a greater number of steps. Additionally, rapid onset of muscle fatigue during FES is caused by synchronous, non-selective, repeated recruitment of largely fatigable muscle fibers.
The researchers will implement an innovative model-predictive controller (MPC) combined with real-time ultrasound-based feedback to deliver optimal FES intensities and minimize fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to the order of the test conditions.
| Arm | Type | Receives |
|---|---|---|
| MPC FES Followed by Conventional FES | Experimental | Device: Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES), Device: Conventional Functional Electrical Stimulation (FES)Post-stroke participants participating in both treadmill and overground walking trials with the novel model-predictive controller (MPC) functional electrical stimulation (FES) system first and with a conventional functional electrical stimulation (FES) system second. |
| Conventional FES Followed by MPC FES | Experimental | Device: Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES), Device: Conventional Functional Electrical Stimulation (FES)Post-stroke participants participating in both treadmill and overground walking trials with a conventional functional electrical stimulation (FES) system first and the novel model-predictive controller (MPC) functional electrical stimulation (FES) system second. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >6 months since stroke
- cortical or subcortical stroke
- able to walk 10-meters with or without an assistive device
- sufficient cardiovascular health and ankle stability to walk on treadmill without ankle orthosis
- passive ankle range of motion to benefit from dorsiflexor FES assistance
Key exclusion criteria (8 listed)
- cerebellar signs
- score >1 on question 1b (does not know the current month and age) and >0 on question 1c (can not blink eyes and squeeze hands) on NIH Stroke Scale
- inability to communicate with investigators
- neglect/hemianopia
- unexplained dizziness in past 6 months
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 |
|---|---|---|
| Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES)The model-predictive controller (MPC) determines the timing and intensity of electrical stimulation delivered for FES. MPC combined with real-time ultrasound-based feedback delivers optimal FES intensities and minimizes fatigue. FES is delivered to the ankle dorsiflexor muscles using a commercially available FDA-approved electrical stimulator. | Device | Conventional FES Followed by MPC FES, MPC FES Followed by Conventional FES |
| Conventional Functional Electrical Stimulation (FES)For functional electrical stimulation, surface electrodes are placed on the paretic leg on skin overlying the tibialis anterior (TA) muscle, with intensity pre-set to elicit dorsiflexion to neutral against gravity. FES will be delivered to the ankle dorsiflexor muscles using a commercially available FDA-approved electrical stimulator. | Device | Conventional FES Followed by MPC FES, MPC FES Followed by Conventional FES |
Primary outcome
Number of Adverse Events
Time frame: Day 1
Safety is assessed as the number of adverse events experienced by study participants.
Count of Risks
Time frame: Day 1
Safety is assessed as the count of risks, including falling, discomfort, pain, skin problems, fatigue, and soreness.
Participant Perception of Comfort
Time frame: Day 1
Participant perception of comfort is measured on an 10-point Likert scale ranging from 1 to 10, where 10 is the most comfortable.
Participant Perception of Acceptability
Time frame: Day 1
Participant perception of acceptability is measured on an 10-point Likert scale ranging from 1 to 10, where 10 is the most acceptable.
Percent of Gait Cycles with Footdrop Correction
Time frame: Day 1
Feasibility of the FES control system is assessed as the percentage of gait cycles with footdrop correction. The FES control system is considered effective if greater than 80% of gait cycles have footdrop correction.
Number of Participants Completing Gait Bouts
Time frame: Day 1
Feasibility of the FES control system is assessed as the number of participants who are able to complete gait bouts with the MPC FES system. The FES control system is considered effective if greater than 80% of participants are able to complete gait bouts.
3 secondary outcomes
Peak Ankle Dorsiflexion Angle During Swing
Time frame: Day 1
Overground Walking Distance
Time frame: Day 1
FES Intensity
Time frame: Day 1
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 16 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for primary dependent variables that underlie the results reported in publications from this study (such as text, tables, appendices) will be made available for sharing with other researchers.
Related trials for Post-stroke Hemiparesis
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Quadriceps Muscle Activity and Gait Kinematics in Patients With Post-Stroke Stiff-Knee Gait Compared With Healthy Controls
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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.
Trisha Kesar, PT, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Functional Electrical Stimulation (FES) in people with Post-stroke Hemiparesis, run by Emory University at 1 site in United States.
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 6 inclusion and 8 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 16 Jul 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 United States. 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 Trisha Kesar, PT, PhD ((404) 712-5803, trisha.m.kesar@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: Day 1). The study lists 6 primary outcomes in all. 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 16 Jul 2026.