Effects of Rehabilitation Robots-Morning Walk in Individuals With Hemiparesis

NCT06374706 | Completed

• 1 other identifier: 23-0129
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Healthy Volunteers

Keywords

End-Effector Robot-Morning Walk; Constrained Induced Movement Therapy; Hemiparesis; Symmetry

Outcome Measures

Primary Outcomes (4)

• The Number of Participants with Kinematic representation of the temporal events during end-effector robot training

  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).

  Pre-overground, Morning walk intervention, and post-overground of assessment in one day and will be recorded continuously for 20-30minutes

• Muscle Activity in the lower extremities

  A wireless electromyographic sensor (Delsys Inc, Natick, MA) will be attached to the participant to analyze muscle activity in the lower extremities.

  Pre-overground, Morning walk intervention, and post-overground of assessment in one day and will be recorded continuously for 20-30minutes

• Spatiotemporal Patterns of Walking, Speeds

  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.

  Pre-overground and post-overground of assessment in one day and will be recorded continuously for 20-30minutes

• Spatiotemporal Patterns of Walking, Parameters

  Subjects will walk on an instrumented mat (Zeno Walkway) with the same model of New Balance shoes to measure the parameters during overground walking.

  Pre-overground and post-overground of assessment in one day and will be recorded continuously for 20-30minutes

Study Arms (2)

Morning Walk Training for Stroke

EXPERIMENTAL

Behavioral: Morning Walk training for stroke

Morning Walk Training for Healthy

ACTIVE COMPARATOR

Behavioral: Morning Walk training for healthy

Interventions

Morning Walk training for stroke 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 Stroke

Morning Walk training for healthy 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.

Morning Walk Training for Healthy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 19, 2024
• Study Start: May 30, 2024
• Primary Completion: February 18, 2025
• Study Completion: March 24, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)