Ankle Exoskeleton for Stroke Gait Enhancement

NCT ID: NCT07179627

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-12-31

Brief Summary

This work will focus on new algorithms for robotic ankle 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., overground, 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 on a proposed novel artificial intelligence (AI) system that self-adapts 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. Stroke survivor participants will be fitted with an ankle exoskeleton and proceed to walk on a treadmill or perform various movement tasks. The same tasks will be performed by the participants without wearing the ankle exoskeleton to serve as a baseline. The investigators expect improved outcomes in the powered ankle exoskeleton compared to baseline conditions.

Conditions

Stroke

Study Design

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

Study Groups

Ankle exoskeleton for stroke gait assistance

This study will be conducted on a sample population of stroke subjects (single arm). Subjects will be tested with the powered ankle exoskeleton and baseline conditions.

Group Type: EXPERIMENTAL

Ankle exoskeleton

Intervention Type: DEVICE

The ankle exoskeleton provides bilateral torque assistance at the ankle joints during common functional tasks such as level-ground walking, stair and ramp ascent, and other daily activities, thereby reducing the mechanical workload and supporting more effective community ambulation. In particular, the device is designed to address drop-foot on the paretic side by delivering bidirectional assistance, which helps improve toe clearance during swing as well as push-off during stance. As a wearable assistive device, assistance is applied only while the device is worn.

Baseline (no ankle exoskeleton)

Intervention Type: OTHER

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

Interventions

Ankle exoskeleton

The ankle exoskeleton provides bilateral torque assistance at the ankle joints during common functional tasks such as level-ground walking, stair and ramp ascent, and other daily activities, thereby reducing the mechanical workload and supporting more effective community ambulation. In particular, the device is designed to address drop-foot on the paretic side by delivering bidirectional assistance, which helps improve toe clearance during swing as well as push-off during stance. As a wearable assistive device, assistance is applied only while the device is worn.

Intervention Type: DEVICE

Baseline (no ankle exoskeleton)

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

Intervention Type: OTHER

Other Intervention Names

Powered ankle exoskeleton

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 you do 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 you 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 you require 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, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgia Institute of Technology

Locations

Georgia Institute of Technology

Atlanta, Georgia, United States

Countries

United States

Central Contacts

Aaron Young, PhD

Role: CONTACT

aaron.young@me.gatech.edu

404-385-5306

Kinsey Herrin, MSPO, C/LPO

Role: CONTACT

kinsey.herrin@gatech.edu

Facility Contacts

Aaron Young, PhD

Role: primary

aaron.young@me.gatech.edu

Other Identifiers

R01HD113598-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB2025-962

Identifier Type: -

Identifier Source: org_study_id