Optimizing Gait Symmetry After Stroke Using Mechanical Constraints and Sensory Feedback
Optimizing Post-Stroke Gait Symmetry: Integrating Mechanical Constraints and Sensory Feedback to Enhance Paretic Leg Propulsion
1 other identifier
interventional
30
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2025
CompletedStudy Start
First participant enrolled
July 25, 2025
CompletedFirst Posted
Study publicly available on registry
July 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 1, 2026
March 1, 2026
1.4 years
July 9, 2025
March 31, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Within a single session (approximately 2 hours)
Secondary Outcomes (10)
Muscle Activity of Lower Extremity During Treadmill and overgrouun Walking
Day 1 (during treadmill and overground walking trials)
Step Length (m) During Overground Walking Using Zeno Walkway
Day 1 (during overground walking trials)
Hip Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System
Day 1 (during treadmill walking trials)
Walking Speed (m/s) During Overground Walking Using Zeno Walkway
Day 1 (during overground walking trials)
Cadence (steps/min) During Overground Walking Using Zeno Walkway
Day 1 (during overground walking trials)
- +5 more secondary outcomes
Study Arms (1)
Gait Training with Combined Sensory Feedback and Mechanical Constraints
EXPERIMENTALAll 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Medical Branch
Galveston, Texas, 77555, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2025
First Posted
July 28, 2025
Study Start
July 25, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 1, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share