CVA (Cerebrovascular Accident)Phase 1NCT04411303
A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation
A Phase 1 study testing Step length biofeedback, Propulsive force biofeedback and Interlimb asymmetry biofeedback in people with CVA (Cerebrovascular Accident), run by University of Southern California at 1 site in United States.
Trial summary
The goal of this project is to determine the feasibility and optimal parameters of a novel, comprehensive approach to gait training in individuals with chronic stroke. The comprehensive approach includes biofeedback-based gait training and aerobic exercise intensity-based gait training. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CVA (Cerebrovascular Accident)
- What is being tested?
- Step length biofeedback, Propulsive force biofeedback and Interlimb asymmetry biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 14 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >6 months post stroke, affecting 1 hemisphere of the brain
- Independently ambulatory (including use assistive devices)
- Able to walk for 5 minutes without stopping
- Demonstrates readiness for exercise based on responses to the PAR-Q+
- Participants enrolled in Aim 2 will require medical clearance from physician to participate
Who cannot join
- Damage to the pons or cerebellum on MRI or signs of cerebellar involvement
- Damage to the basal ganglia or extrapyramidal symptoms
- Uncontrolled hypertension (>160/100mmHg)
- Montreal Cognitive Assessment score < 25
- Orthopedic or pain conditions
- Note*: Pregnant women are excluded from this study to avoid any potential harm to the fetus from the harness used during treadmill walking.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
The goal of this project is to determine the feasibility and optimal parameters of a novel, comprehensive approach to gait training in individuals with chronic stroke. The comprehensive approach includes biofeedback-based gait training and aerobic exercise intensity-based gait training.
Read the detailed description
The goal of this project is to determine the feasibility and optimal parameters of a novel, comprehensive approach to gait training in individuals with chronic stroke. Current post-stroke gait training follows two distinct approaches that target different domains of gait dysfunction (as defined by the International Classification of Functioning, Health, and Disability). Biofeedback-based gait training is typically employed to treat walking pattern impairments (e.g., kinematic deviations relative to able-bodied controls); whereas, aerobic exercise intensity-based gait training is the current gold-standard to treat walking activity limitations (e.g., slow walking speeds). Here, the investigators propose to test the impact of combining these approaches into a single intervention to work toward the development of a more effective, comprehensive approach to gait rehabilitation for persons post-stroke. The central hypothesis is that individuals with chronic stroke have the capacity to use biofeedback to reduce kinematic gait deviations while walking at a range of recommended aerobic exercise intensity zones. Aim 1 will identify the gait biofeedback variable that elicits the largest reduction in interlimb asymmetry in persons post-stroke. Aim 2 will determine the capacity for persons post-stroke to make biofeedback-driven reductions in their interlimb asymmetry while walking at three different aerobic exercise intensities. Participants with chronic stroke in Aim 1 will each complete three experimental sessions and participants in Aim 2 will complete 1 experimental session. Biomechanical analyses and physiologic assessments will be used across both aims to test our working hypotheses. The investigators expect to show that biofeedback of paretic propulsion leads to the greatest reduction in interlimb asymmetry and that participants have the capacity to make biofeedback-driven interlimb asymmetry reductions while walking at all three aerobic intensities, but the magnitude of reduction will be the largest at a moderate aerobic walking intensity. The proposed work is innovative because it will be the first to test the relative effects of different gait biofeedback variables on whole lower extremity kinematics in persons post-stroke and test a novel combination of two well-established gait training approaches (biofeedback- and intensity-based) for neurologic patient populations. This is a critical next step in moving the post-stroke gait rehabilitation field forward. If successful, this line of work stands to significantly improve the current standard of care in gait rehabilitation post-stroke.
- Conditions
- CVA (Cerebrovascular Accident)
- Being tested
- Step length biofeedback, Propulsive force biofeedback, Interlimb asymmetry biofeedback, Aerobic intensity-based walking
- Keywords
- stroke, walking, rehabilitation, aerobic exercise
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step length biofeedbackBehavioural
Participants will be provided with visual feedback of their right and left step lengths on a screen in front of a treadmill.
Propulsive force biofeedbackBehavioural
Participants will be provided with real-time visual feedback of anterior-posterior ground reaction forces of the paretic limb during stance phase on a screen in front of a treadmill.
Interlimb asymmetry biofeedbackBehavioural
Participants will be provided with visual feedback of stride-by-stride values of their interlimb asymmetry on a screen in front of a treadmill.
Aerobic intensity-based walkingBehavioural
Participants will walk at three different aerobic intensities. Aerobic intensity will be set based on target heart rate zones calculated with the Karvonen Formula. For low intensity, participants will walk at 30-40% intensity. In moderate intensity conditions, participants will walk at a 50-60% intensity level. In vigorous intensity conditions, participants will walk at an 70-80% intensity level. Aerobic intensity will be manipulated by changing walking speed.
| Study group | Role | What they receive |
|---|---|---|
| Reducing interlimb asymmetry with biofeedback post-stroke | Experimental | We will use a randomized crossover design to determine the performance and retention effects following single-day training sessions with biofeedback of three different gait variables (i.e., step length, propulsive force, and interlimb asymmetry) in 25 individuals with chronic stroke. Receives: Behavioral: Step length biofeedback; Behavioral: Propulsive force biofeedback; Behavioral: Interlimb asymmetry biofeedback |
| Evaluating capacity for biofeedback use at varied intensities | Experimental | We will use a within-session randomized crossover design to test the capacity of persons post-stroke (second cohort; n=25) to reduce their interlimb asymmetry using the biofeedback variable found to be the most effective for the group in Aim 1 while walking in three aerobic intensity zones: low, moderate, and vigorous (30-40%, 50-60%, and 70-80% of heart rate reserve, respectively). Receives: Behavioral: Aerobic intensity-based walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interlimb Asymmetry - change in performance
characterized as a comparison between the right and left legs of whole lower limb kinematics at heel strike; captured to quantify change in performance with biofeedback
Measured: Measured at three timepoints of interest within each testing session: baseline and at the beginning and end of the biofeedback training; participants will complete 3 testing sessions over approximately 2 months
Secondary outcomes (1)
Interlimb asymmetry - immediate retention
characterized as a comparison between the right and left legs of whole lower limb kinematics at heel strike; captured to quantify retention of a newly learned walking pattern
Measured: Measured after biofeedback training in each testing session; participants will complete 3 testing sessions over approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start9 Jun 2021
- Primary completion14 Aug 2024
- Study completion14 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CVA (Cerebrovascular Accident)Studies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristan Leech, University of Southern California
- Investigators
- Kristan Leech, PT, DPT, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411303
- Sponsor's protocol ID
- HS-20-01887
- Status last verified
- Oct 2025
- First submitted
- 19 May 2020
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified data from our research that underlie results in a publication will be made available.
Publications
Kettlety SA, Finley JM, Leech KA. Within-session propulsion asymmetry changes have a limited effect on gait asymmetry post-stroke. J Neuroeng Rehabil. 2025 Jan 22;22(1):9. doi: 10.1186/s12984-025-01553-8.
PubMed 39844188Kettlety SA, Finley JM, Leech KA. Within-session propulsion asymmetry changes have a limited effect on gait asymmetry post-stroke. Res Sq [Preprint]. 2024 Dec 23:rs.3.rs-5053605. doi: 10.21203/rs.3.rs-5053605/v1.
PubMed 39764092Kettlety SA, Finley JM, Leech KA. Visuospatial Skills Explain Differences in the Ability to Use Propulsion Biofeedback Post-stroke. J Neurol Phys Ther. 2024 Oct 1;48(4):207-216. doi: 10.1097/NPT.0000000000000487. Epub 2024 Sep 17.
PubMed 38912856
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation
- ClinicalTrials.gov ID
- NCT04411303
- Acronym / sponsor ID
- HS-20-01887
- Conditions
- CVA (Cerebrovascular Accident)
- Keywords
- stroke, walking, rehabilitation, aerobic exercise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 14 Dec 2025 (estimated)
- First posted
- 2 Jun 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 goal of this project is to determine the feasibility and optimal parameters of a novel, comprehensive approach to gait training in individuals with chronic stroke. The comprehensive approach includes biofeedback-based gait training and aerobic exercise intensity-based gait training.
Detailed description
The goal of this project is to determine the feasibility and optimal parameters of a novel, comprehensive approach to gait training in individuals with chronic stroke. Current post-stroke gait training follows two distinct approaches that target different domains of gait dysfunction (as defined by the International Classification of Functioning, Health, and Disability). Biofeedback-based gait training is typically employed to treat walking pattern impairments (e.g., kinematic deviations relative to able-bodied controls); whereas, aerobic exercise intensity-based gait training is the current gold-standard to treat walking activity limitations (e.g., slow walking speeds). Here, the investigators propose to test the impact of combining these approaches into a single intervention to work toward the development of a more effective, comprehensive approach to gait rehabilitation for persons post-stroke. The central hypothesis is that individuals with chronic stroke have the capacity to use biofeedback to reduce kinematic gait deviations while walking at a range of recommended aerobic exercise intensity zones. Aim 1 will identify the gait biofeedback variable that elicits the largest reduction in interlimb asymmetry in persons post-stroke. Aim 2 will determine the capacity for persons post-stroke to make biofeedback-driven reductions in their interlimb asymmetry while walking at three different aerobic exercise intensities. Participants with chronic stroke in Aim 1 will each complete three experimental sessions and participants in Aim 2 will complete 1 experimental session. Biomechanical analyses and physiologic assessments will be used across both aims to test our working hypotheses. The investigators expect to show that biofeedback of paretic propulsion leads to the greatest reduction in interlimb asymmetry and that participants have the capacity to make biofeedback-driven interlimb asymmetry reductions while walking at all three aerobic intensities, but the magnitude of reduction will be the largest at a moderate aerobic walking intensity. The proposed work is innovative because it will be the first to test the relative effects of different gait biofeedback variables on whole lower extremity kinematics in persons post-stroke and test a novel combination of two well-established gait training approaches (biofeedback- and intensity-based) for neurologic patient populations. This is a critical next step in moving the post-stroke gait rehabilitation field forward. If successful, this line of work stands to significantly improve the current standard of care in gait rehabilitation post-stroke.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reducing interlimb asymmetry with biofeedback post-stroke | Experimental | Behavioral: Step length biofeedback, Behavioral: Propulsive force biofeedback, Behavioral: Interlimb asymmetry biofeedbackWe will use a randomized crossover design to determine the performance and retention effects following single-day training sessions with biofeedback of three different gait variables (i.e., step length, propulsive force, and interlimb asymmetry) in 25 individuals with chronic stroke. |
| Evaluating capacity for biofeedback use at varied intensities | Experimental | Behavioral: Aerobic intensity-based walkingWe will use a within-session randomized crossover design to test the capacity of persons post-stroke (second cohort; n=25) to reduce their interlimb asymmetry using the biofeedback variable found to be the most effective for the group in Aim 1 while walking in three aerobic intensity zones: low, moderate, and vigorous (30-40%, 50-60%, and 70-80% of heart rate reserve, respectively). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >6 months post stroke, affecting 1 hemisphere of the brain
- Independently ambulatory (including use assistive devices)
- Able to walk for 5 minutes without stopping
- Demonstrates readiness for exercise based on responses to the PAR-Q+
- Participants enrolled in Aim 2 will require medical clearance from physician to participate
Key exclusion criteria (6 listed)
- Damage to the pons or cerebellum on MRI or signs of cerebellar involvement
- Damage to the basal ganglia or extrapyramidal symptoms
- Uncontrolled hypertension (>160/100mmHg)
- Montreal Cognitive Assessment score < 25
- Orthopedic or pain conditions
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 |
|---|---|---|
| Step length biofeedbackParticipants will be provided with visual feedback of their right and left step lengths on a screen in front of a treadmill. | Behavioural | Reducing interlimb asymmetry with biofeedback post-stroke |
| Propulsive force biofeedbackParticipants will be provided with real-time visual feedback of anterior-posterior ground reaction forces of the paretic limb during stance phase on a screen in front of a treadmill. | Behavioural | Reducing interlimb asymmetry with biofeedback post-stroke |
| Interlimb asymmetry biofeedbackParticipants will be provided with visual feedback of stride-by-stride values of their interlimb asymmetry on a screen in front of a treadmill. | Behavioural | Reducing interlimb asymmetry with biofeedback post-stroke |
| Aerobic intensity-based walkingParticipants will walk at three different aerobic intensities. Aerobic intensity will be set based on target heart rate zones calculated with the Karvonen Formula. For low intensity, participants will walk at 30-40% intensity. In moderate intensity conditions, participants will walk at a 50-60% intensity level. In vigorous intensity conditions, participants will walk at an 70-80% intensity level. Aerobic intensity will be manipulated by changing walking speed. | Behavioural | Evaluating capacity for biofeedback use at varied intensities |
Primary outcome
Interlimb Asymmetry - change in performance
Time frame: Measured at three timepoints of interest within each testing session: baseline and at the beginning and end of the biofeedback training; participants will complete 3 testing sessions over approximately 2 months
characterized as a comparison between the right and left legs of whole lower limb kinematics at heel strike; captured to quantify change in performance with biofeedback
1 secondary outcome
Interlimb asymmetry - immediate retention
Time frame: Measured after biofeedback training in each testing session; participants will complete 3 testing sessions over approximately 2 months
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 4 Nov 2025.
- Derived from this study: PubMed 39844188Kettlety SA, Finley JM, Leech KA. Within-session propulsion asymmetry changes have a limited effect on gait asymmetry post-stroke. J Neuroeng Rehabil. 2025 Jan 22;22(1):9. doi: 10.1186/s12984-025-01553-8.
- Derived from this study: PubMed 39764092Kettlety SA, Finley JM, Leech KA. Within-session propulsion asymmetry changes have a limited effect on gait asymmetry post-stroke. Res Sq [Preprint]. 2024 Dec 23:rs.3.rs-5053605. doi: 10.21203/rs.3.rs-5053605/v1.
- Derived from this study: PubMed 38912856Kettlety SA, Finley JM, Leech KA. Visuospatial Skills Explain Differences in the Ability to Use Propulsion Biofeedback Post-stroke. J Neurol Phys Ther. 2024 Oct 1;48(4):207-216. doi: 10.1097/NPT.0000000000000487. Epub 2024 Sep 17.
- Individual participant dataSharing planned: Yes. All de-identified data from our research that underlie results in a publication will be made available.
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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.
Kristan Leech, PT, DPT, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Step length biofeedback, Propulsive force biofeedback and Interlimb asymmetry biofeedback in people with CVA (Cerebrovascular Accident), run by University of Southern California 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 6 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Interlimb Asymmetry - change in performance (time frame: Measured at three timepoints of interest within each testing session: baseline and at the beginning and end of the biofeedback training; participants will complete 3 testing sessions over approximately 2 months). 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 NCT04411303, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.