Adaptive Hip Exoskeleton for Stroke Gait Enhancement

Stroke Clinical Trial

Official title:

Powered Hip Exoskeleton for Stroke Survivors With Gait Impairment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05536739
• Other study ID #: H18182
• Secondary ID: R03HD097740DP2HD
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2026
• Est. completion date: July 31, 2027

Study information

• Verified date: February 2024
• Source: Georgia Institute of Technology
• Contact: Aaron Young, Ph.D.
• Phone: 404-385-5306
• Email: aaron.young[@]me.gatech.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. The study will compare the performance of the advanced algorithm with not using the device to determine the clinical benefit.

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. The investigators hypothesize that walking speed will improve with the use of the self-adaptive control policy system. 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. 12 patients post stroke will be fit with the hip exoskeleton and proceed to walk at varying speeds and inclines on a Motek CAREN system while the investigators measure self-selected walking speed. The self-adaptive system will be compared directly to a best-on-average control policy (non-adaptive) as well as to a 'standard of care' baseline. This baseline will be walking with no exoskeleton plus any clinically prescribed passive orthoses. The investigators expect the self-adaptive system to learn the control policy that best matches the patient's gait patterns, thus yielding advantages in walking speed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: July 31, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

• 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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Robotic hip exoskeleton
The intervention is an experimental robotic hip exoskeleton that has been previously developed by the team. It is used to improve walking gait performance.

Locations

Country	Name	City	State
United States	Exoskeleton and Prosthetic Intelligent Controls Lab	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Georgia Institute of Technology	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Selected Walking Speed	This measures the individuals preferred overground walking speed which indicates their physical capability with a device.	1 year