Optimizing Gait Symmetry After Stroke Using Mechanical Constraints and Sensory Feedback

Not Applicable

Recruiting

• Conditions: Stroke; Split-belt Treadmill; Resistance Exercise; Feedback; Gait Training

• Registration Number: NCT07087769
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-18
• Study Start: 2025-07-25
• Study First Posted: 2025-07-28
• Last Update Submitted: 2025-07-31
• Last Update Posted: 2025-08-03
• Primary Completion: 2026-03-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Paretic Leg Propulsive Force	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 Outcome Measures

Name	Time	Method
Stride Length (m) During Overground Walking Using Zeno Walkway	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.
Muscle Activity of Lower Extremity During Treadmill and overgrouun Walking	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.
Step Length (m) During Overground Walking Using Zeno Walkway	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.
Hip Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System	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.
Walking Speed (m/s) During Overground Walking Using Zeno Walkway	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.
Cadence (steps/min) During Overground Walking Using Zeno Walkway	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.
Swing Time (s) During Overground Walking Using Zeno Walkway	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.
Stance Time (s) During Overground Walking Using Zeno Walkway	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.
Knee Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System	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.
Ankle Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System	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.

Trial Locations

Locations (1)

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States