Clinical trial NCT05536739: Adaptive Hip Exoskeleton for Stroke Gait Enhancement
Official title: Adaptive Hip Exoskeleton for Stroke Survivors With Gait Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Lead sponsor: Georgia Institute of Technology
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-09-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The model used is a repeated measures single arm study
Primary purpose: BASIC_SCIENCE

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.

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
* 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

Primary outcomes:
measure: Temporal Convolutional Network (TCN) model performance (Joint moment accuracy)
timeFrame: 1 year
measure: Metabolic cost for level ground walking
timeFrame: 1 year
measure: Biological joint work
timeFrame: 1 year
Secondary outcomes:
measure: Single limb stance time asymmetry index
timeFrame: 1 year
measure: Step Length Asymmetry index
timeFrame: 1 year
measure: 10 meter walk test (self-selected)
timeFrame: 1 year
measure: 10 meter walk test (fast)
timeFrame: 1 year
measure: The timed up and go (TUG)
timeFrame: 1 year
measure: 2 Minute Walk Test
timeFrame: 1 year
measure: OPUS (Orthotic and Prosthetic User Survey)-Satisfaction module
timeFrame: 1 year
measure: System Usability Scale
timeFrame: 1 year
measure: custom surveys
timeFrame: 1 year
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Exoskeleton and Prosthetic Intelligent Controls Lab
state: Georgia
Study officials:
affiliation: Georgia Institute of Technology
name: Aaron Young, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: