StrokeNCT07087769
Optimizing Gait Symmetry After Stroke Using Mechanical Constraints and Sensory Feedback
A study testing Treadmill Walking with Split-Belt and/or Tied-Belt Conditions, Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacity and Sensory Feedback Training in people with Stroke and Split-belt Treadmill, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
This single-session study aims to evaluate a novel gait training protocol that integrates mechanical constraints and sensory feedback to enhance paretic leg propulsion in individuals post-stroke. The study will include 15 individuals who have experienced a stroke and 15 healthy adults, each aged 20 years or older. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Split-belt Treadmill, Resistance Exercise
- What is being tested?
- Treadmill Walking with Split-Belt and/or Tied-Belt Conditions, Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacity and Sensory Feedback Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2025to 1 Dec 2026
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 20 years or older
- For stroke group: clinical diagnosis of stroke at least 1 month prior to participation
- Ability to walk at least 10 meters with or without assistive devices
- For healthy group: able to walk independently without assistive devices
Who cannot join
- Life expectancy less than one year
- Comatose or unable to follow three-step commands
- Amputation of any lower limb
- Poorly controlled diabetes (e.g., foot ulceration)
- Blindness
- Progressive neurological disease
Show all 11Show fewer
- Medically unstable condition
- Significant musculoskeletal impairments affecting gait
- Congestive heart failure or unstable angina
- Peripheral vascular disease
- Severe neuropsychiatric conditions (e.g., dementia, cognitive deficits, severe depression)
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
University of Texas Medical Branch
Galveston, Texas, 77555
Mansoo Ko, 409-772-9555, mako@utmb.edu
About this study
Official title: Optimizing Post-Stroke Gait Symmetry: Integrating Mechanical Constraints and Sensory Feedback to Enhance Paretic Leg Propulsion
This single-session study aims to evaluate a novel gait training protocol that integrates mechanical constraints and sensory feedback to enhance paretic leg propulsion in individuals post-stroke. The study will include 15 individuals who have experienced a stroke and 15 healthy adults, each aged 20 years or older. Participants will walk on both tied-belt and split-belt treadmills under various training conditions, including backward-directed resistance (applied at the pelvis, ankle, or both) and real-time sensory feedback (visual, auditory, or combined). These interventions will be applied individually and in combination to identify the most effective environment for promoting symmetrical gait patterns. Each session will last approximately two hours. The equipment used is non-invasive, and the risk to participants is minimal.
Read the detailed description
The purpose of this study is to assess the effectiveness of an integrated gait training paradigm that combines mechanical task constraints and sensory feedback during split-belt treadmill walking to enhance paretic leg propulsion and improve propulsion symmetry in individuals post-stroke. The risks associated with this study are lower than those encountered during daily walking in the community and in typical physical therapy clinics, where patients with physical impairments routinely engage in challenging exercises to improve their abilities. There is a slight possibility of local skin irritation or rash resulting from the non-allergenic adhesive tape or sensor gel used to attach the EMG sensors. This is a rare occurrence and typically resolves within one to two days without medical intervention.
This study will last approximately one to two hours, depending on your condition, and involves a one-time visit.
If you choose to participate in this study, the participant will be asked to:
- Sign a consent form approved by the University of Texas Medical Branch IRB, outlining the study's purpose, procedures, benefits, risks, and policies.
- Share medical history and well-being, and have weight, height, and heart rate (via smartwatch) monitored.
- Assess your walking capacity.
- Assess the Optimal Gait Training Protocol using Treadmill, Sensory Feedback, and Mechanical task constraints.
- Conditions
- Stroke, Split-belt Treadmill, Resistance Exercise, Feedback, Gait Training
- Being tested
- Treadmill Walking with Split-Belt and/or Tied-Belt Conditions, Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacity, Sensory Feedback Training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill Walking with Split-Belt and/or Tied-Belt ConditionsBehavioural
Participants will walk on an instrumented treadmill under split-belt and/or tied-belt conditions depending on their walking capacity. The belt speeds will be adjusted to facilitate locomotor adaptation and evaluate propulsion symmetry.
Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacityBehavioural
Participants will walk on a treadmill (Split-belt and/or Tied-belt) with backward-directed resistance applied at the pelvis, ankle, or both. The resistance is used to challenge paretic leg propulsion and assess adaptive gait responses.
Sensory Feedback TrainingBehavioural
Real-time feedback-visual, auditory, or combined-will be provided based on the propulsive force generated during split-belt and/or tied-belt treadmill walking, with or without mechanical resistance.
| Study group | Role | What they receive |
|---|---|---|
| Gait Training with Combined Sensory Feedback and Mechanical Constraints | Experimental | All participants will receive various gait training conditions during a single session. Conditions include treadmill walking (tied-belt and split-belt), backward-directed resistance (applied at pelvis, ankle, or both), sensory feedback (visual, auditory, or combined), and a final combined condition integrating both resistance and feedback. This is a within-subject crossover design. Receives: Behavioral: Treadmill Walking with Split-Belt and/or Tied-Belt Conditions; Behavioral: Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacity; Behavioral: Sensory Feedback Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Paretic Leg Propulsive Force
Peak anterior ground reaction force of the paretic leg will be measured using an instrumented split-belt treadmill . Changes in propulsive force under different treadmill and resistance/feedback conditions will be analyzed to evaluate improvements in gait symmetry.
Measured: Within a single session (approximately 2 hours)
Secondary outcomes (10)
Muscle Activity of Lower Extremity During Treadmill and overgrouun Walking
Surface EMG (Delsys Inc.) will be used to measure activity of major lower limb muscles (e.g., Tibialis anterior and soleus) during treadmill walking under different resistance and feedback conditions.
Measured: Day 1 (during treadmill and overground walking trials)
Step Length (m) During Overground Walking Using Zeno Walkway
Step length (in meters) will be measured using the Zeno Walkway Gait Analysis System during overground walking trials on Day 1. The average step length for each participant will be reported.
Measured: Day 1 (during overground walking trials)
Hip Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System
Hip joint range of motion (ROM), measured in degrees, will be assessed using the Vicon motion capture system during treadmill walking on Day 1. ROM will be defined as the difference between peak flexion and peak extension angles in the sagittal plane. Kinematic data will be collected across multiple gait cycles, and the average ROM per participant will be reported.
Measured: Day 1 (during treadmill walking trials)
Walking Speed (m/s) During Overground Walking Using Zeno Walkway
Walking speed (in meters per second) will be measured using the Zeno Walkway Gait Analysis System during overground walking trials on Day 1. The average walking speed for each participant will be reported.
Measured: Day 1 (during overground walking trials)
Cadence (steps/min) During Overground Walking Using Zeno Walkway
Cadence (in steps per minute) will be measured using the Zeno Walkway Gait Analysis System during overground walking trials on Day 1. The average cadence will be reported per participant.
Measured: Day 1 (during overground walking trials)
Swing Time (s) During Overground Walking Using Zeno Walkway
Swing time (in seconds) will be measured using the Zeno Walkway Gait Analysis System during overground walking trials on Day 1. The average swing time per leg will be reported per participant.
Measured: Day 1 (during overground walking trials)
Stance Time (s) During Overground Walking Using Zeno Walkway
Stance time (in seconds) will be measured using the Zeno Walkway Gait Analysis System during overground walking trials on Day 1. The average stance time per leg will be reported per participant.
Measured: Day 1 (during overground walking trials)
Stride Length (m) During Overground Walking Using Zeno Walkway
Stride length (in meters) will be measured using the Zeno Walkway Gait Analysis System during overground walking trials on Day 1. The average stride length per participant will be reported.
Measured: Day 1 (during overground walking trials)
Knee Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System
Knee joint range of motion (ROM), measured in degrees, will be assessed using the Vicon motion capture system during treadmill walking on Day 1. ROM will be defined as the difference between peak flexion and peak extension angles in the sagittal plane. Multiple gait cycles will be analyzed, and the average ROM per participant will be reported.
Measured: Day 1 (during treadmill walking trials)
Ankle Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System
Ankle joint range of motion (ROM), measured in degrees, will be assessed using the Vicon motion capture system during treadmill walking on Day 1. ROM will be calculated as the difference between peak dorsiflexion and peak plantarflexion angles in the sagittal plane. Data from multiple gait cycles will be averaged and reported per participant.
Measured: Day 1 (during treadmill walking trials)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start25 Jul 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will undergo multiple gait training conditions in a single session, including combinations of treadmill walking (tied-belt and split-belt), backward resistance (pelvis, ankle, or both), and sensory feedback (visual, auditory, or combined). All participants will receive all conditions in a within-subject crossover design.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087769
- Sponsor's protocol ID
- 25-0102
- Status last verified
- Mar 2026
- First submitted
- 9 Jul 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Post-Stroke Gait Symmetry: Integrating Mechanical Constraints and Sensory Feedback to Enhance Paretic Leg Propulsion
- ClinicalTrials.gov ID
- NCT07087769
- Acronym / sponsor ID
- 25-0102
- Conditions
- Stroke, Split-belt Treadmill, Resistance Exercise, Feedback, Gait Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Jul 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 single-session study aims to evaluate a novel gait training protocol that integrates mechanical constraints and sensory feedback to enhance paretic leg propulsion in individuals post-stroke. The study will include 15 individuals who have experienced a stroke and 15 healthy adults, each aged 20 years or older. Participants will walk on both tied-belt and split-belt treadmills under various training conditions, including backward-directed resistance (applied at the pelvis, ankle, or both) and real-time sensory feedback (visual, auditory, or combined). These interventions will be applied individually and in combination to identify the most effective environment for promoting symmetrical gait patterns. Each session will last approximately two hours. The equipment used is non-invasive, and the risk to participants is minimal.
Detailed description
The purpose of this study is to assess the effectiveness of an integrated gait training paradigm that combines mechanical task constraints and sensory feedback during split-belt treadmill walking to enhance paretic leg propulsion and improve propulsion symmetry in individuals post-stroke. The risks associated with this study are lower than those encountered during daily walking in the community and in typical physical therapy clinics, where patients with physical impairments routinely engage in challenging exercises to improve their abilities. There is a slight possibility of local skin irritation or rash resulting from the non-allergenic adhesive tape or sensor gel used to attach the EMG sensors. This is a rare occurrence and typically resolves within one to two days without medical intervention.
This study will last approximately one to two hours, depending on your condition, and involves a one-time visit.
If you choose to participate in this study, the participant will be asked to:
- Sign a consent form approved by the University of Texas Medical Branch IRB, outlining the study's purpose, procedures, benefits, risks, and policies.
- Share medical history and well-being, and have weight, height, and heart rate (via smartwatch) monitored.
- Assess your walking capacity.
- Assess the Optimal Gait Training Protocol using Treadmill, Sensory Feedback, and Mechanical task constraints.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will undergo multiple gait training conditions in a single session, including combinations of treadmill walking (tied-belt and split-belt), backward resistance (pelvis, ankle, or both), and sensory feedback (visual, auditory, or combined). All participants will receive all conditions in a within-subject crossover design.
| Arm | Type | Receives |
|---|---|---|
| Gait Training with Combined Sensory Feedback and Mechanical Constraints | Experimental | Behavioral: Treadmill Walking with Split-Belt and/or Tied-Belt Conditions, Behavioral: Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacity, Behavioral: Sensory Feedback TrainingAll participants will receive various gait training conditions during a single session. Conditions include treadmill walking (tied-belt and split-belt), backward-directed resistance (applied at pelvis, ankle, or both), sensory feedback (visual, auditory, or combined), and a final combined condition integrating both resistance and feedback. This is a within-subject crossover design. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 20 years or older
- For stroke group: clinical diagnosis of stroke at least 1 month prior to participation
- Ability to walk at least 10 meters with or without assistive devices
- For healthy group: able to walk independently without assistive devices
Key exclusion criteria (11 listed)
- Life expectancy less than one year
- Comatose or unable to follow three-step commands
- Amputation of any lower limb
- Poorly controlled diabetes (e.g., foot ulceration)
- Blindness
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 |
|---|---|---|
| Treadmill Walking with Split-Belt and/or Tied-Belt ConditionsParticipants will walk on an instrumented treadmill under split-belt and/or tied-belt conditions depending on their walking capacity. The belt speeds will be adjusted to facilitate locomotor adaptation and evaluate propulsion symmetry. | Behavioural | Gait Training with Combined Sensory Feedback and Mechanical Constraints |
| Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacityParticipants will walk on a treadmill (Split-belt and/or Tied-belt) with backward-directed resistance applied at the pelvis, ankle, or both. The resistance is used to challenge paretic leg propulsion and assess adaptive gait responses. | Behavioural | Gait Training with Combined Sensory Feedback and Mechanical Constraints |
| Sensory Feedback TrainingReal-time feedback-visual, auditory, or combined-will be provided based on the propulsive force generated during split-belt and/or tied-belt treadmill walking, with or without mechanical resistance. | Behavioural | Gait Training with Combined Sensory Feedback and Mechanical Constraints |
Primary outcome
Change in Paretic Leg Propulsive Force
Time frame: Within a single session (approximately 2 hours)
Peak anterior ground reaction force of the paretic leg will be measured using an instrumented split-belt treadmill . Changes in propulsive force under different treadmill and resistance/feedback conditions will be analyzed to evaluate improvements in gait symmetry.
10 secondary outcomes
Muscle Activity of Lower Extremity During Treadmill and overgrouun Walking
Time frame: Day 1 (during treadmill and overground walking trials)
Step Length (m) During Overground Walking Using Zeno Walkway
Time frame: Day 1 (during overground walking trials)
Hip Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System
Time frame: Day 1 (during treadmill walking trials)
Walking Speed (m/s) During Overground Walking Using Zeno Walkway
Time frame: Day 1 (during overground walking trials)
Cadence (steps/min) During Overground Walking Using Zeno Walkway
Time frame: Day 1 (during overground walking trials)
Swing Time (s) During Overground Walking Using Zeno Walkway
Time frame: Day 1 (during overground walking trials)
Stance Time (s) During Overground Walking Using Zeno Walkway
Time frame: Day 1 (during overground walking trials)
Stride Length (m) During Overground Walking Using Zeno Walkway
Time frame: Day 1 (during overground walking trials)
Knee Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System
Time frame: Day 1 (during treadmill walking trials)
Ankle Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System
Time frame: Day 1 (during treadmill walking trials)
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 1 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill Walking with Split-Belt and/or Tied-Belt Conditions, Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacity and Sensory Feedback Training in people with Stroke and Split-belt Treadmill, run by The University of Texas Medical Branch, Galveston 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 4 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: looking for participants now, as of the sponsor's last update on 1 Apr 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 Mansoo Ko, PhD (409-747-1617, mako@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Paretic Leg Propulsive Force (time frame: Within a single session (approximately 2 hours)). 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 1 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.