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NCT07087769NARecruitingAccepts Healthy Volunteers

Optimizing Gait Symmetry After Stroke Using Mechanical Constraints and Sensory Feedback

The University of Texas Medical Branch, Galveston

Start Date

7/25/2025

Completion Date

12/1/2026

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.

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: 1. Sign a consent form approved by the University of Texas Medical Branch IRB, outlining the study's purpose, procedures, benefits, risks, and policies. 2. Share medical history and well-being, and have weight, height, and heart rate (via smartwatch) monitored. 3. Assess your walking capacity. 4. Assess the Optimal Gait Training Protocol using Treadmill, Sensory Feedback, and Mechanical task constraints.

Eligibility Criteria

Age Range: 20 years to No maximum

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)

Interventions

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

Interested in This Trial?

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Conditions

StrokeSplit-belt TreadmillResistance ExerciseFeedbackGait Training

Locations

University of Texas Medical Branch

Galveston, Texas 77555

United States