Optimizing Gait Symmetry After Stroke Using Mechanical Constraints and Sensory Feedback

NCT ID: NCT07087769

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-25
• Study Completion Date: 2026-06-01

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.

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.

Conditions

Stroke; Split-belt Treadmill; Resistance Exercise; Feedback; Gait Training

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Gait Training with Combined Sensory Feedback and Mechanical Constraints

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Texas Medical Branch

Galveston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mansoo Ko, PhD

Role: CONTACT

mako@utmb.edu

409-747-1617

Facility Contacts

Mansoo Ko

Role: primary

mako@utmb.edu

409-772-9555

Other Identifiers

25-0102

Identifier Type: -

Identifier Source: org_study_id