Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374706
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-03-24
Brief Title:
Effects of Rehabilitation Robots-Morning Walk in Individuals With Hemiparesis
Sponsor:
The University of Texas Medical Branch Galveston
Organization:
The University of Texas Medical Branch Galveston
Study Overview
Official Title:
Effects of End-Effector Type Rehabilitation Robots-Morning Walk on Symmetrical Walking Patterns in Individuals With Hemiparesis
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 refusalwithdrawal 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
1 Access the severity of functional and balance capacity prior to gait training Stroke or healthy participants will first be asked questions about their medical history physical functionality and overall well-being Participants will be equipped with an armband or chest strap to monitor their heart rate Functional capacity will be assessed using walking tests on the Zeno Walkway system which evaluates gait speed and spatiotemporal gait parameters during overground walking trials During the testing process participants will be recorded on video
2 Develop the training protocol for the end-effector rehabilitation robot Morning Walk
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 participants walking capacity During the training session participants will be recorded on video
3 Assessing the Immediate Post-Adaptation Effect of Morning Walk Training on the Ground
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
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
1 Access the severity of functional and balance capacity prior to gait training Stroke or healthy participants will first be asked questions about their medical history physical functionality and overall well-being Participants will be equipped with an armband or chest strap to monitor their heart rate Functional capacity will be assessed using walking tests on the Zeno Walkway system which evaluates gait speed and spatiotemporal gait parameters during overground walking trials During the testing process participants will be recorded on video
2 Develop the training protocol for the end-effector rehabilitation robot Morning Walk
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 participants walking capacity During the training session participants will be recorded on video
3 Assessing the Immediate Post-Adaptation Effect of Morning Walk Training on the Ground
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None