Clinical Efficacy of Exoskeleton Assistance for Individuals Post-Stroke

NCT06064604 | Not Yet Recruiting FDA Device

• 2 other identifiers: H23332R01HD113598-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

An exoskeleton device is a robotic system designed to improve an individual's ability to move and perform tasks encountered in everyday situations. These devices consist of external rigid limb segments that assists humans through different body movements with the use of actuators. These devices are controlled by an onboard computer that determines the timing and magnitude of assistance deployed to the user. Exoskeleton controller performance is key to providing beneficial assistance that does not inhibit the user's movement. Preceding work will compare the benefit of personalized hip versus ankle joint exoskeleton assistance for improvement of post-stroke gait. It will combine exoskeleton technology with the user's movement feedback to improve wearable robotic assistance to an individual stroke survivor's gait pattern. For the clinical trial research covered under this protocol, the investigator will test various exoskeleton technologies with stroke survivors in real-world contexts, indoors and outdoors, and measure clinically meaningful outcomes and user perceptions regarding technology usability and adoption. The long-term goal is to deploy self-adaptive, adoptable exoskeletons for personalized assistance during community ambulation.

Conditions

Stroke

Keywords

Stoke; Robotic Exoskeleton; Gait

Outcome Measures

Primary Outcomes (4)

• 10 meter walk test (10MWT)

  This measures the individual's preferred overground walking speed, indicating their physical capability with an exoskeleton device

  2 weeks

• 6-minute walk test (6MWT)

  This measures the individual's walking distance over 6 minutes to assess aerobic endurance.

  2 weeks

• Physiological Cost Index

  This measures the individual's oxygen consumption while walking. It will be calculated using a 6-minute walk test (6MWT) and heart rate.

  2 weeks

• Borg Rating of Perceived Exertion (RPE)

  This measures the individual's perceived physical activity intensity level, indicating how hard the individuals believes their body is working to conduct walking tasks with and without the exoskeleton devices.

  2 weeks

Study Arms (1)

Stroke Survivors

EXPERIMENTAL

This study will be divided into 2 sessions that will occur on 2 separate days: 1) Hip Exoskeleton session and 2) Ankle Exoskeleton session. In each session, subjects will undergo two conditions in which they complete the outcomes measures 1) while wearing the exoskeleton and 2) in a baseline condition without the exoskeleton. Order of condition and session will be randomized. Prior to the exoskeleton condition, subjects will be allowed time to acclimate to the device during a walking session on the treadmill. Subjects will complete several timed walking tests both indoors and outdoors. Measurements of energy expenditure may also be recorded along with patient reported outcomes data to assess participant perception of their performance with and without the devices.

Other: Control; Device: Hip Exoskeleton; Device: Ankle Exoskeleton

Interventions

Control OTHER

The stroke survivors will serve as their own control group. The participants will complete the required tasks without an exoskeleton device.

Also known as: No-exoskeleton

Stroke Survivors

Hip Exoskeleton DEVICE

The Georgia Tech Hip Exo is a wearable robotic device for hip extension/flexion assistance. This device will be used to study the lower limb movement and how to effectively assist users. It makes use of a responsive controller that considers information such as joint angles to understand the user's state and assists with the appropriate level of power accordingly.

Also known as: Georgia Tech Hip Expo

Stroke Survivors

Ankle Exoskeleton DEVICE

The Dephy Exoboot is a lower limb exoskeleton which attaches to the user below the knee through a cuff at the proximal calf and a provided shoe. This investigational device is used to make it easier for able-bodied and impaired individuals to walk and run under a variety of conditions. The exoskeleton provides assistance at the ankle joint during movement. The purpose is to assist the user in lower limb movements such as ground level walking, climbing stairs/ramps, and sit-to-stand.

Also known as: Dephy ExoBoot

Stroke Survivors

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18-85 years of age
• Stroke at least 6 months prior to study involvement
• Community dwelling (participant does not live in an assisted living facility)
• 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 (the participant can walk without the assistance of another person)

You may not qualify if:

• Requires a walker to walk independently
• Has a shuffling gait pattern overground
• Has a Functional Ambulation Category (FAC) score of 2 or lower (the participant requires the assistance of another person in order to walk)
• Has 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.

Sponsors & Collaborators

• Georgia Institute of Technology: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Exoskeleton and Prosthetic Intelligent Controls Lab

Atlanta, Georgia, 30332, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aaron Young, PhD

  Georgia Institute of Technology

  PRINCIPAL INVESTIGATOR

• Greg Sawicki

  Georgia Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron Young, PhD

CONTACT

404-385-5306; aaron.young@me.gatech.edu

Greg Sawicki, PhD

CONTACT

404-385-5706; greg.sawicki@me.gatech.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study includes one pre-specified group, stroke survivors, to receive intervention with two exoskeleton devices.

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)