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NCT Number: NCT07087769

Optimizing Gait Symmetry After Stroke Using Mechanical Constraints and Sensory Feedback

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Feedback Gait Training Nervous System Diseases Resistance Exercise Split-belt Treadmill Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location status: Recruiting

Location contact

Mansoo Ko

CONTACT

[email protected]

409-772-9555

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

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)

Treatment and study plan

Treadmill Walking with Split-Belt and/or Tied-Belt Conditions

Behavioral

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 capacity

Behavioral

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 Training

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Muscle Activity of Lower Extremity During Treadmill and overgrouun Walking

    Time frame: Day 1 (during treadmill and overground walking trials)

    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.

  2. Step Length (m) During Overground Walking Using Zeno Walkway

    Time frame: Day 1 (during overground walking trials)

    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.

  3. Hip Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System

    Time frame: Day 1 (during treadmill walking trials)

    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.

  4. Walking Speed (m/s) During Overground Walking Using Zeno Walkway

    Time frame: Day 1 (during overground walking trials)

    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.

  5. Cadence (steps/min) During Overground Walking Using Zeno Walkway

    Time frame: Day 1 (during overground walking trials)

    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.

  6. Swing Time (s) During Overground Walking Using Zeno Walkway

    Time frame: Day 1 (during overground walking trials)

    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.

  7. Stance Time (s) During Overground Walking Using Zeno Walkway

    Time frame: Day 1 (during overground walking trials)

    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.

  8. Stride Length (m) During Overground Walking Using Zeno Walkway

    Time frame: Day 1 (during overground walking trials)

    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.

  9. Knee Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System

    Time frame: Day 1 (during treadmill walking trials)

    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.

  10. Ankle 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 (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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mansoo Ko, PhD

CONTACT

[email protected]

409-747-1617

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

Optimizing Post-Stroke Gait Symmetry: Integrating Mechanical Constraints and Sensory Feedback to Enhance Paretic Leg Propulsion

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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