Effects of Rehabilitation Robots-Morning Walk in Individuals With Hemiparesis

NCT ID: NCT06374706

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2025-03-24

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 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.

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 participant's 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.

Conditions

Stroke; Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Morning Walk Training for Stroke

Group Type: EXPERIMENTAL

Morning Walk training for stroke

Intervention Type: BEHAVIORAL

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.

Morning Walk Training for Healthy

Group Type: ACTIVE_COMPARATOR

Morning Walk training for healthy

Intervention Type: BEHAVIORAL

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.

Interventions

Morning Walk training for stroke

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.

Intervention Type: BEHAVIORAL

Morning Walk training for healthy

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Experienced a unilateral first stroke, either ischemic or hemorrhagic, in the carotid artery distribution.
• Diagnosed with stroke at least one month prior to participating in the study.
• Free from major post-stroke complications, such as recurrent stroke, hip fracture, or myocardial infarction.
• Residing within the community.
• Capable of ambulating 10 meters with or without the use of assistive devices.

Exclusion Criteria

• Stroke secondary to subarachnoid hemorrhage or posterior circulation stroke.
• Life expectancy of less than one year.
• Comatose state.
• Inability to follow 3-step commands.
• Amputation.
• Poorly controlled diabetes, exemplified by conditions such as foot ulceration.
• Blindness.
• Progressive neurological diseases.
• Comprehensive aphasia.
• Medical instability.
• Significant musculoskeletal problems.
• Congestive cardiac failure.
• Unstable angina.
• Peripheral vascular disease.
• Neuropsychiatric disorders, including dementia, cognitive deficits, and 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

Countries

United States

Other Identifiers

23-0129

Identifier Type: -

Identifier Source: org_study_id