StrokeNCT04380454
Biomechanical and Neural Mechanisms of Post-stroke Gait Training
A study testing Functional electrical stimulation (FES) and Fast treadmill walking in people with Stroke, run by Emory University at 1 site in United States.
Trial summary
The study seeks to develop an understanding of how, why, and for whom fast treadmill walking (Fast) and Fast with functional electrical stimulation (FastFES) induce clinical benefits, allowing future development of cutting-edge, individually-tailored gait treatments that enhance both gait quality and gait function. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Functional electrical stimulation (FES) and Fast treadmill walking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 1 Oct 2025
- 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 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 6 months since stroke
- single cortical or subcortical ischemic stroke
- able to walk 10-meters with or without assistive device
- sufficient cardiovascular health and ankle stability to walk on treadmill for 2-minutes at self-selected speed without orthosis
- resting heart rate 40-100 bpm
Who cannot join
- hemorrhagic stroke
- cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements
- score of >1 on question 1b and >0 on question 1c on NIH Stroke Scale
- inability to communicate with investigators
- musculoskeletal conditions or pain that limit walking
- neglect/hemianopia, or unexplained dizziness in last 6 months
Show all 11Show fewer
- neurologic conditions or diagnoses other than stroke
- lack of sensation in lower limb affected by stroke
- any medical diagnosis that would hinder the participant from completing the experimental trial
- diabetes not controlled by medication or causing risk for participation in exercise programs
- additional exclusion criteria due to contra-indications to TMS (measurement of corticospinal excitability) are: history of seizures, metal implants in the head or face, history of recurring or severe headaches/migraine, headache within the past 24 hours, presence of skull abnormalities or fractures, hemorrhagic stroke, history of dizziness, syncope, nausea, or loss of consciousness in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
The study seeks to develop an understanding of how, why, and for whom fast treadmill walking (Fast) and Fast with functional electrical stimulation (FastFES) induce clinical benefits, allowing future development of cutting-edge, individually-tailored gait treatments that enhance both gait quality and gait function.
Read the detailed description
Stroke is the leading cause of adult disability in the United States, with stroke prevalence expected to increase by 20% in the next 20 years. Stroke induces a cascade of neurophysiologic changes in cortical and spinal circuits that result in biomechanical impairments (reduced paretic propulsion, footdrop) and gait dysfunction (reduced speed and endurance). This study evaluates neurobiological and biomechanics mechanisms of two gait (walking) rehabilitation treatments. Gait impairments persist at discharge from rehabilitation in over two thirds of stroke survivors, reducing community participation and quality of life.
Stroke gait deficits are complex and multi-factorial, posing a problem well-matched to the NIH precision medicine initiative. Stroke gait impairments adversely affect kinematics and kinetics in all paretic lower limb joints, disrupt stance and swing phases, and are marked by inter-limb asymmetry. One intervention cannot target all post-stroke gait deficits. Multiple factors, including biomechanics, energy cost, and functioning and integrity of corticomotor neural pathways can influence stroke gait function and training-induced gait improvements.
Fast treadmill walking (Fast) is an evidence-based, clinically-used intervention, comprising high-intensity, high-repetition, bilateral stepping practice. High-intensity treadmill training was recommended by clinical practice guidelines for locomotor training at the 2018 American Physical Therapy Association (APTA) conference. Fast provides practice of thousands of steps and aerobic exercise, which may induce bilateral neuroplasticity. However, without adjunctive feedback or cues (verbal, biofeedback, stimulation), Fast is not targeted to specific gait deficits or the paretic leg. Importantly, neural correlates underlying Fast are unclear. A single session of high-intensity interval treadmill walking exacerbated already suppressed ankle muscle corticospinal excitability in the paretic leg post-stroke. Four weeks of treadmill training in chronic stroke improved gait speed compared to control treatment, but increased cortical excitability in the non-lesioned hemisphere. Despite Fast and treadmill-based interventions gaining clinical popularity, important questions pertaining to neural mechanisms of Fast are unknown.
Recent work has demonstrated that combining Fast with functional electrical stimulation (FastFES) not only leads to improvements in gait speed but also reduces energy cost (EC) of stroke gait. FastFES is an intervention combining fast treadmill training and functional electrical stimulation (FES) to ankle plantar- and dorsi-flexor muscles during paretic terminal stance and swing phases, respectively. As a paradigm for studying gait training mechanisms, FastFES offers several advantages including using hypothesis-based biomechanical approach to improve gait function by targeting impairments in paretic propulsion, and is delivered only to the paretic leg.
The study seeks to develop an understanding of how, why, and for whom fast treadmill walking (Fast) and Fast with functional electrical stimulation (FastFES) induce clinical benefits, allowing future development of cutting-edge, individually-tailored gait treatments that enhance both gait quality and gait function.
This mechanism-focused randomized clinical investigation will compare the effects of 12 sessions of Fast and FastFES in individuals with post-stroke hemiparesis. Gait biomechanics, EC, corticospinal excitability, and gait function will be evaluated at two baseline visits,after 3 gait training sessions, after 12 gait training sessions, and at two follow-ups (3 and 6 weeks post-training).
- Conditions
- Stroke
- Being tested
- Functional electrical stimulation (FES), Fast treadmill walking
- Keywords
- Rehabilitation, Post-stroke, Neural mechanism, Biomechanical mechanism, Electrical stimulation, Gait Training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional electrical stimulation (FES)Device
Functional electrical stimulation (FES) is a targeted intervention that provides motor level stimulation-induced cues to improve ankle propulsion. An electrical stimulator will be used to deliver stimulation during walking (Grass S8800 stimulator with SIU8TB stimulus isolation unit; UDel stimulator). A customized, real-time system will be used to control the stimulator and deliver stimulation during appropriate phases of the gait cycle. Stimulation will be delivered to the ankle dorsiflexors when the subject's foot is in the air (swing phase). Stimulation will be delivered to the ankle plantarflexors during the terminal stance phase of gait. 30-Hz variable frequency stimulation trains 170 will be delivered during gait. The intervention comprises 3 training sessions per week for a total of 12 training sessions. FES intensity is determined at the start of every training session as motor-level stimulation that elicits appropriate functional movements.
Fast treadmill walkingOther
Fast treadmill walking (Fast) is a non-targeted intervention where no specific instructions are provided to target practice to the paretic leg or specific ankle deficits. The intervention comprises 3 training sessions per week for a total of 12 training sessions. Each training session includes six 6-minute walking bouts with 5-minute breaks between bouts.
| Study group | Role | What they receive |
|---|---|---|
| Fast treadmill walking with functional electrical stimulation (FastFES) | Experimental | Participants with post-stroke hemiparesis who are randomized to receive 12 sessions of FastFES. FastFES is a targeted intervention that provides motor level stimulation-induced cues to improve ankle propulsion. FES is delivered only to the paretic ankle muscles, enhancing afferent ascending as well as descending corticomotor drive. Increased corticomotor drive in lesioned corticomotor circuits in turn promotes improved timing and intensity of muscle activation in the paretic plantar- and dorsi-flexor muscles, increasing plantarflexor moment and propulsion from the paretic ankle. Receives: Device: Functional electrical stimulation (FES); Other: Fast treadmill walking |
| Fast treadmill walking (Fast) | Active comparator | Participants with post-stroke hemiparesis who are randomized to receive 12 sessions of Fast. Fast is a non-targeted intervention that provides similar structure, dose, and intensity of stepping practice as FastFES, but does not include FES, and no specific instructions are provided to target practice to the paretic leg or specific ankle deficits Receives: Other: Fast treadmill walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Propulsion Symmetry
Propulsive asymmetry between the non-paretic and paretic peak anterior ground reaction forces (AGRF) has been shown to correlate with walking function. Propulsion, evaluated through AGRF, is crucial for propelling the body forward. Gait biomechanics testing is conducted in the motion analysis assessing gait asymmetry. A 7-camera system is used to collect motion analysis data. Ground reaction forces during treadmill walking will be collected using force platforms.
Measured: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
Change in 10-Meter Walk Test at Self-selected Walking Speed
The 10-Meter Walk Test is used to assess walking speed over a short distance. A 10 meter (m) walkway over solid flooring will be measured and marked at start (0 m), 2 m, 8 m, and finish (10 m). Participants will be asked to complete three trials of the 10 m walk at their comfortable self-selected walking speed. The time for the three trials for each speed will be averaged and gait speed converted to meters/second.
Measured: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
Change in 10-Meter Walk Test at Fast Walking Speed
The 10-Meter Walk Test is used to assess walking speed over a short distance. A 10 m walkway over solid flooring will be measured and marked at start (0 m), 2 m, 8 m, and finish (10 m). Participants will be asked to complete three trials of the 10 m walk at their fast walking speed. The time for the three trials for each speed will be averaged and gait speed converted to meters/second.
Measured: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
Change in Paretic Soleus TMS Motor Evoked Potential (MEP) Amplitude
Change in MEP amplitude is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES.
Measured: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
Secondary outcomes (5)
Change in energy cost (EC) of walking
Energy cost (EC) of walking is measured as the rate of energy use, computed from rates of oxygen consumption and carbon dioxide production. Energy cost of walking, is calculated as the oxygen consumption during V02 assessment collected during treadmill walking at self selected (SS) speed, normalized to body weight (kg) and speed (m/min) to yield the energy cost (ml O^2/kg/m). Elevated EC related to activity intolerance, sedentary lifestyle, and physical deconditioning.
Measured: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
Change in 6-Minute Walk Test
The 6-Minute Walk Test is a sub-maximal exercise test used to assess walking endurance. A walkway of a minimum 12 m over solid flooring will be measured and marked with a turn-around marked at either end of the walkway. The turn-around points will be approximately 49 inches (124 cm) wide with clear markings. A chair will be placed at one end of the walkway to allow for seated rest breaks if necessary. Prior to administering the test, the participant will be seated in the chair resting. The participant will then be asked to walk as far as possible in 6 minutes along the walkway using scripted instruction (see below). The distance (in meters) will be calculated by multiplying the number of total laps by 12 meters and adding the distance of the partial lap completed at the time the test ended.
Measured: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
Change in Timed Up and Go (TUG) Test
The Timed Up and Go test assesses mobility, balance, walking ability, and fall risk in older adults. The participant will be asked to be seated in a standard height chair (seat height 46 cm, arm height 67 cm), placing his/her back against the chair and resting his/her arms on the chair's arms. The participant will be asked to get up from the chair, walk to a line 3 m from the edge of the chair, turn around at the line, walk back to the chair, and sit down. The test will be timed using a stopwatch from when the investigator says "Go" to when the participant's buttocks touches the chair upon return. Time of the test will be recorded.
Measured: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
Change in intracortical facilitation (ICF)
Intracortical facilitation (ICF) can be elicited by transcranial magnetic stimulation (TMS) of the motor cortex. Change in Intracortical facilitation (ICF) will be recorded.
Measured: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
Change in H-max/M-max ratio for the soleus
H-max/M-max ratio for the soleus will be calculated. Change in (Hmax/Mmax) ratio is used as a measure of spinal reflex excitability, that is assessed using peripheral electrical stimulation delivered to the nerves innervating the muscles.
Measured: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start16 Mar 2021
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
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
- NCT04380454
- Sponsor's protocol ID
- IRB00109530
- Other IDs
- R01HD095975, 2025P009490
- Status last verified
- Sep 2026
- First submitted
- 4 May 2020
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data for primary dependent variables that underlie the results reported in this article, after de-identification (such as text, tables, appendices) will be shared
Publications
Parikh V, Slusarenko A, Spencer J, Hope JM, Aloba FK, Grewal AS, Alterman BL, Batts K, Mason CF, Zajac-Cox L, Caston S, Borich MR, Nocera J, Kesar TM. Biomechanical and neural correlates of FastFES versus Fast gait training in individuals post stroke: a randomized control trial study protocol. Front Neurol. 2026 Jul 2;17:1792419. doi: 10.3389/fneur.2026.1792419. eCollection 2026.
PubMed 42491658
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical and Neural Mechanisms of Post-stroke Gait Training
- ClinicalTrials.gov ID
- NCT04380454
- Acronym / sponsor ID
- IRB00109530
- Conditions
- Stroke
- Keywords
- Rehabilitation, Post-stroke, Neural mechanism, Biomechanical mechanism, Electrical stimulation, Gait Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 8 May 2020 (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.
The study seeks to develop an understanding of how, why, and for whom fast treadmill walking (Fast) and Fast with functional electrical stimulation (FastFES) induce clinical benefits, allowing future development of cutting-edge, individually-tailored gait treatments that enhance both gait quality and gait function.
Detailed description
Stroke is the leading cause of adult disability in the United States, with stroke prevalence expected to increase by 20% in the next 20 years. Stroke induces a cascade of neurophysiologic changes in cortical and spinal circuits that result in biomechanical impairments (reduced paretic propulsion, footdrop) and gait dysfunction (reduced speed and endurance). This study evaluates neurobiological and biomechanics mechanisms of two gait (walking) rehabilitation treatments. Gait impairments persist at discharge from rehabilitation in over two thirds of stroke survivors, reducing community participation and quality of life.
Stroke gait deficits are complex and multi-factorial, posing a problem well-matched to the NIH precision medicine initiative. Stroke gait impairments adversely affect kinematics and kinetics in all paretic lower limb joints, disrupt stance and swing phases, and are marked by inter-limb asymmetry. One intervention cannot target all post-stroke gait deficits. Multiple factors, including biomechanics, energy cost, and functioning and integrity of corticomotor neural pathways can influence stroke gait function and training-induced gait improvements.
Fast treadmill walking (Fast) is an evidence-based, clinically-used intervention, comprising high-intensity, high-repetition, bilateral stepping practice. High-intensity treadmill training was recommended by clinical practice guidelines for locomotor training at the 2018 American Physical Therapy Association (APTA) conference. Fast provides practice of thousands of steps and aerobic exercise, which may induce bilateral neuroplasticity. However, without adjunctive feedback or cues (verbal, biofeedback, stimulation), Fast is not targeted to specific gait deficits or the paretic leg. Importantly, neural correlates underlying Fast are unclear. A single session of high-intensity interval treadmill walking exacerbated already suppressed ankle muscle corticospinal excitability in the paretic leg post-stroke. Four weeks of treadmill training in chronic stroke improved gait speed compared to control treatment, but increased cortical excitability in the non-lesioned hemisphere. Despite Fast and treadmill-based interventions gaining clinical popularity, important questions pertaining to neural mechanisms of Fast are unknown.
Recent work has demonstrated that combining Fast with functional electrical stimulation (FastFES) not only leads to improvements in gait speed but also reduces energy cost (EC) of stroke gait. FastFES is an intervention combining fast treadmill training and functional electrical stimulation (FES) to ankle plantar- and dorsi-flexor muscles during paretic terminal stance and swing phases, respectively. As a paradigm for studying gait training mechanisms, FastFES offers several advantages including using hypothesis-based biomechanical approach to improve gait function by targeting impairments in paretic propulsion, and is delivered only to the paretic leg.
The study seeks to develop an understanding of how, why, and for whom fast treadmill walking (Fast) and Fast with functional electrical stimulation (FastFES) induce clinical benefits, allowing future development of cutting-edge, individually-tailored gait treatments that enhance both gait quality and gait function.
This mechanism-focused randomized clinical investigation will compare the effects of 12 sessions of Fast and FastFES in individuals with post-stroke hemiparesis. Gait biomechanics, EC, corticospinal excitability, and gait function will be evaluated at two baseline visits,after 3 gait training sessions, after 12 gait training sessions, and at two follow-ups (3 and 6 weeks post-training).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast treadmill walking with functional electrical stimulation (FastFES) | Experimental | Device: Functional electrical stimulation (FES), Other: Fast treadmill walkingParticipants with post-stroke hemiparesis who are randomized to receive 12 sessions of FastFES. FastFES is a targeted intervention that provides motor level stimulation-induced cues to improve ankle propulsion. FES is delivered only to the paretic ankle muscles, enhancing afferent ascending as well as descending corticomotor drive. Increased corticomotor drive in lesioned corticomotor circuits in turn promotes improved timing and intensity of muscle activation in the paretic plantar- and dorsi-flexor muscles, increasing plantarflexor moment and propulsion from the paretic ankle. |
| Fast treadmill walking (Fast) | Active comparator | Other: Fast treadmill walkingParticipants with post-stroke hemiparesis who are randomized to receive 12 sessions of Fast. Fast is a non-targeted intervention that provides similar structure, dose, and intensity of stepping practice as FastFES, but does not include FES, and no specific instructions are provided to target practice to the paretic leg or specific ankle deficits |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- at least 6 months since stroke
- single cortical or subcortical ischemic stroke
- able to walk 10-meters with or without assistive device
- sufficient cardiovascular health and ankle stability to walk on treadmill for 2-minutes at self-selected speed without orthosis
- resting heart rate 40-100 bpm
Key exclusion criteria (11 listed)
- hemorrhagic stroke
- cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements
- score of >1 on question 1b and >0 on question 1c on NIH Stroke Scale
- inability to communicate with investigators
- musculoskeletal conditions or pain that limit walking
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 stimulation (FES)Functional electrical stimulation (FES) is a targeted intervention that provides motor level stimulation-induced cues to improve ankle propulsion. An electrical stimulator will be used to deliver stimulation during walking (Grass S8800 stimulator with SIU8TB stimulus isolation unit; UDel stimulator). A customized, real-time system will be used to control the stimulator and deliver stimulation during appropriate phases of the gait cycle. Stimulation will be delivered to the ankle dorsiflexors when the subject's foot is in the air (swing phase). Stimulation will be delivered to the ankle plantarflexors during the terminal stance phase of gait. 30-Hz variable frequency stimulation trains 170 will be delivered during gait. The intervention comprises 3 training sessions per week for a total of 12 training sessions. FES intensity is determined at the start of every training session as motor-level stimulation that elicits appropriate functional movements. | Device | Fast treadmill walking with functional electrical stimulation (FastFES) |
| Fast treadmill walkingFast treadmill walking (Fast) is a non-targeted intervention where no specific instructions are provided to target practice to the paretic leg or specific ankle deficits. The intervention comprises 3 training sessions per week for a total of 12 training sessions. Each training session includes six 6-minute walking bouts with 5-minute breaks between bouts. | Other | Fast treadmill walking (Fast), Fast treadmill walking with functional electrical stimulation (FastFES) |
Primary outcome
Change in Gait Propulsion Symmetry
Time frame: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
Propulsive asymmetry between the non-paretic and paretic peak anterior ground reaction forces (AGRF) has been shown to correlate with walking function. Propulsion, evaluated through AGRF, is crucial for propelling the body forward. Gait biomechanics testing is conducted in the motion analysis assessing gait asymmetry. A 7-camera system is used to collect motion analysis data. Ground reaction forces during treadmill walking will be collected using force platforms.
Change in 10-Meter Walk Test at Self-selected Walking Speed
Time frame: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
The 10-Meter Walk Test is used to assess walking speed over a short distance. A 10 meter (m) walkway over solid flooring will be measured and marked at start (0 m), 2 m, 8 m, and finish (10 m). Participants will be asked to complete three trials of the 10 m walk at their comfortable self-selected walking speed. The time for the three trials for each speed will be averaged and gait speed converted to meters/second.
Change in 10-Meter Walk Test at Fast Walking Speed
Time frame: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
The 10-Meter Walk Test is used to assess walking speed over a short distance. A 10 m walkway over solid flooring will be measured and marked at start (0 m), 2 m, 8 m, and finish (10 m). Participants will be asked to complete three trials of the 10 m walk at their fast walking speed. The time for the three trials for each speed will be averaged and gait speed converted to meters/second.
Change in Paretic Soleus TMS Motor Evoked Potential (MEP) Amplitude
Time frame: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
Change in MEP amplitude is used as a measure of corticospinal excitability that is assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). Electrical activity from muscles in response to the TMS will be collected using surface electromyography (EMG) sensors attached to muscles that play critical roles during FastFES.
5 secondary outcomes
Change in energy cost (EC) of walking
Time frame: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
Change in 6-Minute Walk Test
Time frame: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
Change in Timed Up and Go (TUG) Test
Time frame: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
Change in intracortical facilitation (ICF)
Time frame: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)
Change in H-max/M-max ratio for the soleus
Time frame: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-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 8 Sep 2026.
- Derived from this study: PubMed 42491658Parikh V, Slusarenko A, Spencer J, Hope JM, Aloba FK, Grewal AS, Alterman BL, Batts K, Mason CF, Zajac-Cox L, Caston S, Borich MR, Nocera J, Kesar TM. Biomechanical and neural correlates of FastFES versus Fast gait training in individuals post stroke: a randomized control trial study protocol. Front Neurol. 2026 Jul 2;17:1792419. doi: 10.3389/fneur.2026.1792419. eCollection 2026.
- Individual participant dataSharing planned: Yes. Individual participant data for primary dependent variables that underlie the results reported in this article, after de-identification (such as text, tables, appendices) will be shared
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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. This study is not recruiting at the moment.
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 Functional electrical stimulation (FES) and Fast treadmill walking in people with Stroke, 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 5 inclusion and 11 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 8 Sep 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?
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 Propulsion Symmetry (time frame: Baseline, after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)). The study lists 4 primary outcomes in all. 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 NCT04380454, which also lists 1 linked publication.
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 8 Sep 2026.