StrokeNCT06064604
Clinical Efficacy of Exoskeleton Assistance for Individuals Post-Stroke
A study testing Hip Exoskeleton and Ankle Exoskeleton in people with Stroke, run by Georgia Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Hip Exoskeleton and Ankle Exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Exoskeleton and Prosthetic Intelligent Controls Lab
Atlanta, Georgia, 30332
Aaron Young, Ph.D., 404-385-5306, aaron.young@me.gatech.edu
Greg Sawicki, PhD, 470-578-7600, greg.sawicki@me.gatech.edu
About this study
Official title: Clinical Trial: Powered Hip & Ankle Exoskeletons for Stroke Survivors With Gait Impairment
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.
Read the detailed description
Participants will serve as their own control in this study. 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 proceed to complete a timed indoor community circuit in which they will complete a 10 meter walk test over an instrumented gait mat which will record information about their walking. The indoor community circuit may also include turning, walking up/down a ramp and walking up/down a staircase.
Subjects will then proceed to complete an outdoor 6-minute walk test (6MWT) on a pre-defined course on Georgia Tech's campus. When outdoors, participants will be guarded with a gait belt and a researcher who will walk alongside them throughout the experiment to reduce the risk for a fall. Borg Rating of Perceived Exertion (RPE) and Physiological Cost Index (PCI) will be assessed and calculated following completion of the 6MWT. Following each condition, subjects will then sit, rest and complete a suite of patient reported outcomes in which the investigators will ask questions about their perception of their performance with and without the device; investigators will also ask them questions about the device. Following completion of surveys, subjects will repeat the same outcomes for the other condition- either the baseline condition or the exoskeleton condition, depending on the initial randomization.
Throughout the procedures, subjects will be monitored for fatigue and asked if they need a break. They will be encouraged to voice any concerns (discomfort, fatigue or otherwise) to the research personnel, who will respond accordingly. Participants will be guarded with a gait belt or harness to reduce the risk of falls while participating in the protocol.
- Conditions
- Stroke
- Being tested
- Control, Hip Exoskeleton, Ankle Exoskeleton
- Keywords
- Stoke, Robotic Exoskeleton, Gait
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called No-exoskeleton
The stroke survivors will serve as their own control group. The participants will complete the required tasks without an exoskeleton device.
Hip ExoskeletonDevice
Also called Georgia Tech Hip Expo
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.
Ankle ExoskeletonDevice
Also called Dephy ExoBoot
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Control; Device: Hip Exoskeleton; Device: Ankle Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meter walk test (10MWT)
This measures the individual's preferred overground walking speed, indicating their physical capability with an exoskeleton device
Measured: 2 weeks
6-minute walk test (6MWT)
This measures the individual's walking distance over 6 minutes to assess aerobic endurance.
Measured: 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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study includes one pre-specified group, stroke survivors, to receive intervention with two exoskeleton devices.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgia Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Aaron Young, PhD, Principal investigator, Georgia Institute of TechnologyGreg Sawicki, Principal investigator, Georgia Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064604
- Sponsor's protocol ID
- H23332
- Other IDs
- R01HD113598-01
- Status last verified
- Nov 2025
- First submitted
- 26 Sep 2023
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial: Powered Hip & Ankle Exoskeletons for Stroke Survivors With Gait Impairment
- ClinicalTrials.gov ID
- NCT06064604
- Acronym / sponsor ID
- H23332
- Conditions
- Stroke
- Keywords
- Stoke, Robotic Exoskeleton, Gait
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Georgia Institute of TechnologyUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will serve as their own control in this study. 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 proceed to complete a timed indoor community circuit in which they will complete a 10 meter walk test over an instrumented gait mat which will record information about their walking. The indoor community circuit may also include turning, walking up/down a ramp and walking up/down a staircase.
Subjects will then proceed to complete an outdoor 6-minute walk test (6MWT) on a pre-defined course on Georgia Tech's campus. When outdoors, participants will be guarded with a gait belt and a researcher who will walk alongside them throughout the experiment to reduce the risk for a fall. Borg Rating of Perceived Exertion (RPE) and Physiological Cost Index (PCI) will be assessed and calculated following completion of the 6MWT. Following each condition, subjects will then sit, rest and complete a suite of patient reported outcomes in which the investigators will ask questions about their perception of their performance with and without the device; investigators will also ask them questions about the device. Following completion of surveys, subjects will repeat the same outcomes for the other condition- either the baseline condition or the exoskeleton condition, depending on the initial randomization.
Throughout the procedures, subjects will be monitored for fatigue and asked if they need a break. They will be encouraged to voice any concerns (discomfort, fatigue or otherwise) to the research personnel, who will respond accordingly. Participants will be guarded with a gait belt or harness to reduce the risk of falls while participating in the protocol.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study includes one pre-specified group, stroke survivors, to receive intervention with two exoskeleton devices.
| Arm | Type | Receives |
|---|---|---|
| Stroke Survivors | Experimental | Other: Control, Device: Hip Exoskeleton, Device: Ankle ExoskeletonThis 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlAlso: No-exoskeletonThe stroke survivors will serve as their own control group. The participants will complete the required tasks without an exoskeleton device. | Other | Stroke Survivors |
| Hip ExoskeletonAlso: Georgia Tech Hip ExpoThe 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. | Device | Stroke Survivors |
| Ankle ExoskeletonAlso: Dephy ExoBootThe 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. | Device | Stroke Survivors |
Primary outcome
10 meter walk test (10MWT)
Time frame: 2 weeks
This measures the individual's preferred overground walking speed, indicating their physical capability with an exoskeleton device
6-minute walk test (6MWT)
Time frame: 2 weeks
This measures the individual's walking distance over 6 minutes to assess aerobic endurance.
Physiological Cost Index
Time frame: 2 weeks
This measures the individual's oxygen consumption while walking. It will be calculated using a 6-minute walk test (6MWT) and heart rate.
Borg Rating of Perceived Exertion (RPE)
Time frame: 2 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron Young, PhD principal investigator
Georgia Institute of Technology
Greg Sawicki principal investigator
Georgia Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip Exoskeleton and Ankle Exoskeleton in people with Stroke, run by Georgia Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aaron Young, PhD (404-385-5306, aaron.young@me.gatech.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 meter walk test (10MWT) (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.