Optimizing Gait Symmetry After Stroke Using Mechanical Constraints and Sensory Feedback
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorThe University of Texas Medical Branch, Galveston
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Treadmill Walking with Split-Belt and/or Tied-Belt Conditions
BehavioralParticipants 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
BehavioralParticipants 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
BehavioralReal-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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Gait Training with Combined Sensory Feedback and Mechanical ConstraintsExperimental treatment 3 interventions
Trial outcomes
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.
Time frame
Within a single session (approximately 2 hours)Secondary outcomes
1
Muscle Activity of Lower Extremity During Treadmill and overgrouun Walking
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.
Time frame
Day 1 (during treadmill and overground walking trials)2
Step Length (m) During Overground Walking Using Zeno Walkway
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.
Time frame
Day 1 (during overground walking trials)3
Hip Joint Range of Motion (degrees) During Treadmill Walking Using Vicon Motion Capture System
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.
Time frame
Day 1 (during treadmill walking trials)4
Walking Speed (m/s) During Overground Walking Using Zeno Walkway
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.
Time frame
Day 1 (during overground walking trials)Sponsors and contacts
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Source ClinicalTrials.gov