HealthyEarly Phase 1NCT06999213
Lower Limb ExoNET: Development and Evaluation for Gait Assistance With Stroke Survivors
A Early Phase 1 study testing Assist, Resist and Slack in people with Healthy, run by Shirley Ryan AbilityLab.
Trial summary
Stroke-related gait impairments, such as poor limb coordination, imbalance, and reduced push-off strength, are often addressed using robotic systems or electrical stimulation, which can be costly, invasive, or insufficient for long-term recovery. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Assist, Resist and Slack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2026to 31 Dec 2029
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70 years old
- Ability to provide informed consent
- Capable of ambulating without the use of assistive devices for 2 hours
Who cannot join
- History of stroke, SCI, or other neurological medical diagnoses
- Pregnant
- Severe medical diagnoses (e.g. cardiovascular, orthopedic)
- Skin allergies or irritation; open wounds
- Prisoners
- Cognitively impaired adults
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Stroke-related gait impairments, such as poor limb coordination, imbalance, and reduced push-off strength, are often addressed using robotic systems or electrical stimulation, which can be costly, invasive, or insufficient for long-term recovery. Current devices often assist movement but fail to promote functional motor learning. Research supports rehabilitation strategies that amplify gait errors to drive neuroplasticity and adaptation. The LegExoNET (Exoskeletal Network for Elastic Torque) is a novel, passive wearable exoskeleton designed to address this need by enabling both assistive and therapeutic gait training. It stores and releases elastic energy to aid movement while allowing natural joint motion. The system aims to support individuals post-stroke transitioning to independent rehabilitation by offering a lightweight, affordable, and adaptive solution. Initial testing will focus on healthy individuals to assess safety and feasibility before expanding to stroke populations. The LegExoNET has the potential to enhance gait recovery and reduce therapist burden through error augmentation and personalized support, both in clinical and at-home settings.
- Conditions
- Healthy
- Being tested
- Assist, Resist, Slack
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssistOther
The device will provide assistive torques to support either ankle, knee, and/or hip movements.
ResistOther
Also called Anti-Assistance
The device will apply resistive torques to exaggerate gait asymmetries, facilitating error augmentation.
SlackOther
The device will be worn but will not generate any torque.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive Sham → Assist → Resist in a crossover design. Receives: Other: Assist; Other: Resist; Other: Slack |
| Group 2 | Experimental | Participants will receive Sham → Resist → Assist in a crossover design Receives: Other: Assist; Other: Resist; Other: Slack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography (EMG) amplitude during walking under each intervention condition
Muscle activation (specifically voltage amplitude) using wearable surface EMG of the gastrocnemius, lateral gastrocnemius, tibialis anterior, soleus, biceps femoris, rectus femoris, and gluteus maximus.
Measured: Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)
Secondary outcomes (3)
6 Minute Walk Test
- The score of the test is the distance a patient walks in 6 minutes. Walking is self-paced on a standardized walk space using standardized instructions.
- The patient may take as many standing rests as they like, but the timer should kept running and the number of rests taken and the total rest time recorded.
- Assistive devices are allowed and must be documented.
- Clinician assistance is permitted and must be from posterior so as not to pace the participant, and the level of assist must be documented.
- When administering the test, do not walk in front of or directly beside the patient, as this may "pace" the patient and influence the speed and distance they walk. Instead, walk at least a half step behind the patient.
- If a participant cannot walk but has goals and expectations to regain walking, a 6MWT score of 0 should be documented.
- No talking should be done with the participant during the test other than the scripted and timed feedback outlined in the 6MWT guidelines.
Measured: Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)
10 Meter Walk Test
The individual is instructed to walk a set distance (6 meters, 10 meters, etc). Time is measured while the individual walks the set distance (often the individual is given space to accelerate to his/her preferred walking speed (this distance is not included when determining speed). The distance covered is divided by the time it took the individual to walk that distance.
Measured: Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)
Gait Symmetry
Collect gait symmetry and other gait parameters such as stride length, using Kinect v2, GaitRite, and OpenCap. Kinect v2 tracks 3D joint kinematics to assess symmetry (left-right differences), stride length (foot displacement), and parameters like step time and velocity. GaitRite's pressure-sensitive walkway measures precise stride length, symmetry (step length/time differences), and parameters such as cadence and stance time. OpenCap, with multiple cameras and cloud processing, captures 3D kinematics to calculate symmetry, stride length, joint angles, and the Gait Deviation Index (GDI). Data will be synchronized, systems calibrated, and participants will walk naturally for analysis using dedicated software and scripts, ensuring comprehensive gait evaluation.
Measured: Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start31 Jan 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Lanphier Patton, Shirley Ryan AbilityLab
- Investigators
- James L Patton, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999213
- Sponsor's protocol ID
- STU00223221
- Status last verified
- Jul 2025
- First submitted
- 7 Apr 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Limb ExoNET: Development and Evaluation for Gait Assistance With Stroke Survivors
- ClinicalTrials.gov ID
- NCT06999213
- Acronym / sponsor ID
- STU00223221
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 31 May 2025 (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.
Stroke-related gait impairments, such as poor limb coordination, imbalance, and reduced push-off strength, are often addressed using robotic systems or electrical stimulation, which can be costly, invasive, or insufficient for long-term recovery. Current devices often assist movement but fail to promote functional motor learning. Research supports rehabilitation strategies that amplify gait errors to drive neuroplasticity and adaptation. The LegExoNET (Exoskeletal Network for Elastic Torque) is a novel, passive wearable exoskeleton designed to address this need by enabling both assistive and therapeutic gait training. It stores and releases elastic energy to aid movement while allowing natural joint motion. The system aims to support individuals post-stroke transitioning to independent rehabilitation by offering a lightweight, affordable, and adaptive solution. Initial testing will focus on healthy individuals to assess safety and feasibility before expanding to stroke populations. The LegExoNET has the potential to enhance gait recovery and reduce therapist burden through error augmentation and personalized support, both in clinical and at-home settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Assist, Other: Resist, Other: SlackParticipants will receive Sham → Assist → Resist in a crossover design. |
| Group 2 | Experimental | Other: Assist, Other: Resist, Other: SlackParticipants will receive Sham → Resist → Assist in a crossover design |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-70 years old
- Ability to provide informed consent
- Capable of ambulating without the use of assistive devices for 2 hours
Key exclusion criteria (6 listed)
- History of stroke, SCI, or other neurological medical diagnoses
- Pregnant
- Severe medical diagnoses (e.g. cardiovascular, orthopedic)
- Skin allergies or irritation; open wounds
- Prisoners
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 |
|---|---|---|
| AssistThe device will provide assistive torques to support either ankle, knee, and/or hip movements. | Other | Group 1, Group 2 |
| ResistAlso: Anti-AssistanceThe device will apply resistive torques to exaggerate gait asymmetries, facilitating error augmentation. | Other | Group 1, Group 2 |
| SlackThe device will be worn but will not generate any torque. | Other | Group 1, Group 2 |
Primary outcome
Electromyography (EMG) amplitude during walking under each intervention condition
Time frame: Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)
Muscle activation (specifically voltage amplitude) using wearable surface EMG of the gastrocnemius, lateral gastrocnemius, tibialis anterior, soleus, biceps femoris, rectus femoris, and gluteus maximus.
3 secondary outcomes
6 Minute Walk Test
Time frame: Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)
10 Meter Walk Test
Time frame: Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)
Gait Symmetry
Time frame: Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)
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 30 Jul 2025.
- Individual participant dataSharing planned: Yes
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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.
James L Patton, PhD principal investigator
Shirley Ryan AbilityLab
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Assist, Resist and Slack in people with Healthy, run by Shirley Ryan AbilityLab.
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 3 inclusion and 6 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 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Marc Camardo (224-422-7182, mcamardo@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography (EMG) amplitude during walking under each intervention condition (time frame: Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)). 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 30 Jul 2025.