Optimizing Gait Symmetry After Stroke Using Mechanical Constraints and Sensory Feedback

Official title

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

Overview

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.

Interventions

• Behavioral Treadmill Walking with Split-Belt and/or Tied-Belt Conditions
  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.
• Behavioral Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacity
  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.
• Behavioral Sensory Feedback Training
  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 outcome measures

• Change in Paretic Leg Propulsive Force [Time frame: Within a single session (approximately 2 hours)]

Secondary outcome measures (10)

• 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)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• University of Texas Medical Branch — Galveston

Identifiers

NCT: NCT07087769 · 25-0102

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗