Adaptive Hip Exoskeleton for Stroke Gait Enhancement

NCT ID: NCT05536739

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-21
• Study Completion Date: 2027-07-31

Brief Summary

This work will focus on new algorithms for robotic exoskeletons and testing these in human subject tests. Individuals who have previously had a stroke will walk while wearing a robotic exoskeleton on a specialized treadmill as well as during other movement tasks (e.g. over ground, stairs, ramps). The study will compare the performance of the advanced algorithm with not using the device to determine the clinical benefit.

Detailed Description

The focus of this work is a proposed novel artificial intelligence (AI) system to self-adapt control policy in powered exoskeletons to aid deployment systems that personalize to individual patient gait. Individuals post stroke have a broad range of mobility challenges including asymmetric gait, substantially decreased SSWS, and reduced stability, and therefore have greatly impaired overall mobility independence in the community. The investigators expect the proposed novel controller, capable of personalization to such variable and asymmetric gait patterns, will have significant benefits towards increasing community independence and mobility for patients post stroke. Patients post stroke will be fit with a hip exoskeleton (in a powered and/or unpowered state) and proceed to walk on a treadmill or perform various movement tasks. The same tasks will be performed by the patients without wearing the hip exoskeleton to serve as a baseline. The investigators expect improved outcomes in the powered hip exoskeleton compared to the unpowered hip exoskeleton and baseline conditions.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Hip Exoskeleton for Stroke Gait Assistance

This study will be conducted on a sample population of stroke subjects (single arm). Subjects will be tested with either the powered hip exoskeleton and baseline or powered hip exoskeleton, unpowered hip exoskeleton, and baseline.

Group Type: EXPERIMENTAL

Robotic hip exoskeleton

Intervention Type: DEVICE

The intervention is an experimental robotic hip exoskeleton in a powered state providing assistance to the user that has been previously developed by the team. It is used to improve walking gait performance.

No hip exoskeleton

Intervention Type: OTHER

The intervention will serve as a baseline where participants will be asked to perform the tasks without wearing a hip exoskeleton.

Unpowered hip exoskeleton

Intervention Type: DEVICE

The intervention is an experimental robotic hip exoskeleton in an unpowered state that has been previously developed by the team. It is used to improve walking gait performance.

Interventions

Robotic hip exoskeleton

The intervention is an experimental robotic hip exoskeleton in a powered state providing assistance to the user that has been previously developed by the team. It is used to improve walking gait performance.

Intervention Type: DEVICE

No hip exoskeleton

The intervention will serve as a baseline where participants will be asked to perform the tasks without wearing a hip exoskeleton.

Intervention Type: OTHER

Unpowered hip exoskeleton

The intervention is an experimental robotic hip exoskeleton in an unpowered state that has been previously developed by the team. It is used to improve walking gait performance.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Between 18-85 years of age
• Had a stroke at least 6 months prior to study involvement
• Are community dwelling, which means the participant does not live in an assisted living facility
• Are able to provide informed consent to participate in the study activities
• Can safely participate in the study activities (per self-report)
• Must have a Functional Ambulation Category (FAC) score of 3 or above, which means the participant can walk without the assistance of another person

Exclusion Criteria

• Require a walker to walk independently
• Have a shuffling gait pattern overground
• Have a Functional Ambulation Category (FAC) score of 2 or lower, which means the participant requires the assistance of another person in order to walk
• Have a significant secondary deficit beyond stroke (e.g. amputation, legal blindness or other severe impairment or condition) that in the opinion of the Principal Investigator (PI), would likely affect the study outcome or confound the results
• For exoskeleton-only studies, the exoskeleton device does not fit appropriately or safely, as determined by the research team during the fitting assessment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Georgia Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron Young, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Georgia Institute of Technology

Locations

Exoskeleton and Prosthetic Intelligent Controls Lab

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Aaron Young, Ph.D.

Role: CONTACT

aaron.young@me.gatech.edu

404-385-5306

Kinsey R Herrin, MSPO, C/LPO

Role: CONTACT

kinsey.herrin@me.gatech.edu

470-578-7600

Facility Contacts

Aaron Young, Ph.D.

Role: primary

aaron.young@me.gatech.edu

404-385-5306

Other Identifiers

R03HD097740

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DP2HD111709

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H18182

Identifier Type: -

Identifier Source: org_study_id