University of Texas Medical Branch
Galveston, Texas, 77555, United States
NCT Number: NCT06374706
In this study, our objective is to explore and evaluate interventions to improve the process of recovery following a stroke. The main focus is on enhancing symmetrical walking patterns in adults who have experienced neurological deficits due to a stroke. The primary tool will be an end-effector type rehabilitation robot, the Morning Walk®. This robot has been specifically designed to assist in enhancing symmetrical walking patterns for individuals recovering from a stroke Morning Walk® has received approval from the FDA, meaning it meets stringent safety and efficacy standards.
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Notify Me20 year and older
All sexes
Interventional
Not applicable
Galveston, Texas, 77555, United States
Total forty participants (20 stroke vs 20 healthy individuals) will sign a consent form that is pre-approved by the Institutional Review Board at the participating facilities, which states the purpose of the study, an explanation of the procedures, benefits and risks for the participant, a confidentiality statement, and a refusal/withdrawal policy.
This study will assess the feasibility of end-effector rehabilitation robots, specifically Morning Walk®, to optimize training outcomes and improve symmetry in individuals with stroke.
Prior to the end-effector robot training, Investigators will attach six Delsys wireless electromyographic sensors (Delsys Inc, Natick, MA) to analyze muscle activity in the lower extremities. Additionally, stroke or healthy participants will be equipped with the Tekscan In-Shoes system (Tekscan, Inc., South Boston) to assess temporal events related to foot positioning during training, such as limb loading time. During the end-effector robot training, a saddle-type weight support and secure strap system will be employed to prevent loss of balance or falls. Following an appropriate warm-up and familiarization with the end-effector robot training, various walking parameters of Morning Walk, such as pace, stride length, step height, and initial contact angle, will be examined to achieve balanced loading times between the paretic and non-paretic sides in stroke participants. Training parameters such as step length, step height, and joint angle can be independently adjusted for the paretic and non-paretic sides in stroke patients, and for the dominant and non-dominant sides in healthy individuals. This approach allows for the restriction of movement in the non-paretic or non-dominant side, thereby encouraging the activity of the paretic or dominant side during training. The adaptation training parameters will be adjusted according to the participant's walking capacity. During the training session, participants will be recorded on video.
Stroke or healthy participants will be asked to on the Zeno Walkway system to evaluate gait speed and spatiotemporal gait parameters during overground walking trials. During the testing process, participants will be recorded on video.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Assessing the Feasibility of the End-Effector Rehabilitation Robot, Morning Walk Training and investigate the Immediate Post-Adaptation Effect of Morning Walk Training for Symmetrical Walking on the Ground.
Assessing the Feasibility of the End-Effector Rehabilitation Robot, Morning Walk Training and investigate the Immediate Post-Adaptation Effect of Morning Walk Training for Asymmetrical Walking on the Ground.
Time frame: Pre-overground, Morning walk intervention, and post-overground of assessment in one day and will be recorded continuously for 20-30minutes
The temporal events of foot position and foot pressure distributions will be identified from ground reaction forces (GRFs) during walking trials using the Tekscan In-shoes system (Tekscan, Inc., South Boston).
Time frame: Pre-overground, Morning walk intervention, and post-overground of assessment in one day and will be recorded continuously for 20-30minutes
A wireless electromyographic sensor (Delsys Inc, Natick, MA) will be attached to the participant to analyze muscle activity in the lower extremities.
Time frame: Pre-overground and post-overground of assessment in one day and will be recorded continuously for 20-30minutes
Subjects will walk on an instrumented mat (Zeno Walkway) with the same model of New Balance shoes to measure self-selected and fastest comfortable speeds.
Time frame: Pre-overground and post-overground of assessment in one day and will be recorded continuously for 20-30minutes
Subjects will walk on an instrumented mat (Zeno Walkway) with the same model of New Balance shoes to measure the parameters during overground walking.
The University of Texas Medical Branch, Galveston
Other
Effects of End-Effector Type Rehabilitation Robots-Morning Walk on Symmetrical Walking Patterns in Individuals With Hemiparesis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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