Adaptive Hip Exoskeleton for Stroke Gait Enhancement

Georgia Institute of Technology

Status: Enrolling

Conditions: Stroke

Treatments: Other: No hip exoskeleton; Device: Robotic hip exoskeleton; Device: Unpowered hip exoskeleton

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05536739

DP2HD111709 (U.S. NIH Grant/Contract)

R03HD097740 (U.S. NIH Grant/Contract)

H18182

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Hip Exoskeleton for Stroke Gait Assistance

Experimental group

Description:

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.

Treatment:

Device: Unpowered hip exoskeleton

Device: Robotic hip exoskeleton

Other: No hip exoskeleton