Healthy Young AdultsNCT07393971
Development of a Real-time Controller to Estimate Walking Performance Using a Bilateral Ankle Exoskeleton
A study of Healthy Young Adults, run by University of Nebraska at 1 site in United States.
Trial summary
This study is developing and testing a new controller for a robotic ankle exoskeleton (Biomotum) that can adjust itself in real time to better support people while they walk. The system learns how each person moves and automatically changes the amount and timing of assistance to make walking feel easier and more… Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 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 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- able to walk independently on a treadmill for 10 minutes,
- free of neurological, cardiovascular, pulmonary, or musculoskeletal conditions that limit walking and exercising,
- no current lower extremity pain or injury,
- able to wear an exoskeleton and safety harness, can provide informed consent
Who cannot join
- history of neurological disease that affected gait or balance,
- current or recent lower extremity musculoskeletal injury or surgery,
- chronic lower extremity pain during walking,
- inability to participate in moderate-intensity exercise,
- require an assistive device for walking,
- any metabolic or systemic diseases that may be exacerbated by exercise
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
Biomechanics Research Building, University of Nebraska at Omaha
Omaha, Nebraska, 68108
About this study
Official title: Controller Development to Enable Individualized Assistance in Robotic Ankle Exoskeletons
This study is developing and testing a new controller for a robotic ankle exoskeleton (Biomotum) that can adjust itself in real time to better support people while they walk. The system learns how each person moves and automatically changes the amount and timing of assistance to make walking feel easier and more efficient. By using information from the person wearing the device, the exoskeleton can quickly find the level of support that works best for them. The long-term goal is to create personalized walking assistance that can help people with mobility limitations move more comfortably and with less effort.
Read the detailed description
This project aims to develop and test a real-time adaptive controller for a robotic ankle exoskeleton (Biomotum) that personalizes assistance to each user by minimizing metabolic cost and optimizing muscle activation patterns during walking. Using human-in-the-loop optimization and advanced musculoskeletal modeling, the controller will dynamically adjust torque magnitude and timing to achieve optimal performance more quickly than current methods.
- Conditions
- Healthy Young Adults
- Being tested
- Adaptive Torque Control System for Ankle Exoskeleton
- Keywords
- robotic ankle exoskeleton, human-in-the-loop optimization, wearable robotics, musculoskeletal modeling, muscle activation analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Torque Control System for Ankle ExoskeletonDevice
This intervention uses a robotic ankle exoskeleton equipped with a real-time adaptive controller that adjusts plantarflexion torque based on each participant's walking mechanics. Unlike standard exoskeleton controllers that use fixed or pre-programmed assistance levels, this system employs human-in-the-loop optimization to continuously update torque magnitude and timing during treadmill walking. The controller integrates metabolic estimations, kinematic data, and musculoskeletal modeling to identify individualized assistance patterns that reduce walking effort and improve muscle activation efficiency. Participants complete multiple walking trials while the controller automatically modifies assistance to determine the optimal personalized settings.
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm Study of a Personalized Robotic Ankle Exoskeleton Controller | Experimental | This arm employs a within-subject design with two methods of estimating metabolic cost versus the gold standard measure of metabolic cost, wherein a single participant is subjected to two distinct measurements. This design allows for a direct comparison of the effects of each method (i.e., estimation versus gold standard) within the same individual, minimizing intersubject variability and enhancing the statistical power of the analysis. Receives: Device: Adaptive Torque Control System for Ankle Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Real-Time Operation of the Robotic Ankle Exoskeleton Controller
Device feasibility will be evaluated by the successful real-time operation of the robotic ankle exoskeleton and adaptive controller during treadmill walking. Feasibility is defined as the controller's ability to continuously generate, update, and apply assistive torque in real time based on incoming biomechanical and physiological data without system failure, interruption, or safety-related termination. Successful operation will be confirmed by continuous controller function and synchronized data acquisition across walking trials.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Net Metabolic Rate During Exoskeleton-Assisted Walking Measured by Indirect Calorimetry
Net oxygen consumption (VO₂) and carbon dioxide production (VCO₂) will be measured during treadmill walking using indirect calorimetry (Cosmed K5, Cosmed USA Inc., Chicago, IL). Metabolic rate will be calculated using standard equations during steady-state walking conditions. Measurements will be collected at regular intervals to characterize metabolic demand under different exoskeleton assistance configurations.
Measured: through study completion, an average of 1 year
Estimated Metabolic Rate Derived From Joint-Space Musculoskeletal Modeling
Estimated metabolic rate will be derived from joint-space musculoskeletal models using kinematic and kinetic data collected during treadmill walking. Model-based estimates will be computed on a stride-by-stride basis to provide an indirect estimate of metabolic demand that can be compared with direct measurements from indirect calorimetry.
Measured: through study completion, an average of 1 year
Estimated Lower-Limb Muscle Activation Derived From Joint-Space Musculoskeletal Modeling
Lower-limb muscle activation patterns will be estimated using joint-space musculoskeletal models based on motion capture and ground reaction force data collected during treadmill walking. Estimated muscle activation values will be computed on a stride-by-stride basis to characterize neuromuscular engagement during exoskeleton-assisted gait.
Measured: through study completion, an average of 1 year
Lower-Limb Muscle Activation Measured by Surface Electromyography During Walking
Muscle activation of lower-limb muscles (e.g., tibialis anterior, gastrocnemius medialis, gastrocnemius lateralis, soleus) will be measured during treadmill walking using surface electromyography (Delsys). EMG signals will be collected continuously and processed to quantify muscle activation patterns during exoskeleton-assisted gait.
Measured: through study completion, an average of 1 year
During treadmill walking trials conducted at a single study visit
Controller parameter convergence will be assessed during human-in-the-loop optimization trials by evaluating changes in controller gain and timing parameters across successive walking bouts. Convergence is defined as stabilization of controller parameters within a predefined range during the optimization process.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Sep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Young AdultsStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Madonna Rehabilitation Hospital
- Responsible party
- Sponsor
- Investigators
- Farah Fallahtafti, PhD, Principal investigator, Department of Biomechanics, University of Nebraska at Omaha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393971
- Sponsor's protocol ID
- 0587-25-FB
- Other IDs
- 55136
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared because direct measurements are only taken for baseline measurements that the modeling software will be using. The scripts and code used will be shared through opensource, but that does not include subject data.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controller Development to Enable Individualized Assistance in Robotic Ankle Exoskeletons
- ClinicalTrials.gov ID
- NCT07393971
- Acronym / sponsor ID
- 0587-25-FB
- Conditions
- Healthy Young Adults
- Keywords
- robotic ankle exoskeleton, human-in-the-loop optimization, wearable robotics, musculoskeletal modeling, muscle activation analysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Madonna Rehabilitation Hospital
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Feb 2026 (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.
This study is developing and testing a new controller for a robotic ankle exoskeleton (Biomotum) that can adjust itself in real time to better support people while they walk. The system learns how each person moves and automatically changes the amount and timing of assistance to make walking feel easier and more efficient. By using information from the person wearing the device, the exoskeleton can quickly find the level of support that works best for them. The long-term goal is to create personalized walking assistance that can help people with mobility limitations move more comfortably and with less effort.
Detailed description
This project aims to develop and test a real-time adaptive controller for a robotic ankle exoskeleton (Biomotum) that personalizes assistance to each user by minimizing metabolic cost and optimizing muscle activation patterns during walking. Using human-in-the-loop optimization and advanced musculoskeletal modeling, the controller will dynamically adjust torque magnitude and timing to achieve optimal performance more quickly than current methods.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm Study of a Personalized Robotic Ankle Exoskeleton Controller | Experimental | Device: Adaptive Torque Control System for Ankle ExoskeletonThis arm employs a within-subject design with two methods of estimating metabolic cost versus the gold standard measure of metabolic cost, wherein a single participant is subjected to two distinct measurements. This design allows for a direct comparison of the effects of each method (i.e., estimation versus gold standard) within the same individual, minimizing intersubject variability and enhancing the statistical power of the analysis. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- able to walk independently on a treadmill for 10 minutes,
- free of neurological, cardiovascular, pulmonary, or musculoskeletal conditions that limit walking and exercising,
- no current lower extremity pain or injury,
- able to wear an exoskeleton and safety harness, can provide informed consent
Key exclusion criteria (6 listed)
- history of neurological disease that affected gait or balance,
- current or recent lower extremity musculoskeletal injury or surgery,
- chronic lower extremity pain during walking,
- inability to participate in moderate-intensity exercise,
- require an assistive device for walking,
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 |
|---|---|---|
| Adaptive Torque Control System for Ankle ExoskeletonThis intervention uses a robotic ankle exoskeleton equipped with a real-time adaptive controller that adjusts plantarflexion torque based on each participant's walking mechanics. Unlike standard exoskeleton controllers that use fixed or pre-programmed assistance levels, this system employs human-in-the-loop optimization to continuously update torque magnitude and timing during treadmill walking. The controller integrates metabolic estimations, kinematic data, and musculoskeletal modeling to identify individualized assistance patterns that reduce walking effort and improve muscle activation efficiency. Participants complete multiple walking trials while the controller automatically modifies assistance to determine the optimal personalized settings. | Device | Single-Arm Study of a Personalized Robotic Ankle Exoskeleton Controller |
Primary outcome
Successful Real-Time Operation of the Robotic Ankle Exoskeleton Controller
Time frame: through study completion, an average of 1 year
Device feasibility will be evaluated by the successful real-time operation of the robotic ankle exoskeleton and adaptive controller during treadmill walking. Feasibility is defined as the controller's ability to continuously generate, update, and apply assistive torque in real time based on incoming biomechanical and physiological data without system failure, interruption, or safety-related termination. Successful operation will be confirmed by continuous controller function and synchronized data acquisition across walking trials.
5 secondary outcomes
Net Metabolic Rate During Exoskeleton-Assisted Walking Measured by Indirect Calorimetry
Time frame: through study completion, an average of 1 year
Estimated Metabolic Rate Derived From Joint-Space Musculoskeletal Modeling
Time frame: through study completion, an average of 1 year
Estimated Lower-Limb Muscle Activation Derived From Joint-Space Musculoskeletal Modeling
Time frame: through study completion, an average of 1 year
Lower-Limb Muscle Activation Measured by Surface Electromyography During Walking
Time frame: through study completion, an average of 1 year
During treadmill walking trials conducted at a single study visit
Time frame: through study completion, an average of 1 year
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 21 Aug 2026.
- Individual participant dataSharing planned: No. IPD will not be shared because direct measurements are only taken for baseline measurements that the modeling software will be using. The scripts and code used will be shared through opensource, but that does not include subject data.
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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.
Farah Fallahtafti, PhD principal investigator
Department of Biomechanics, University of Nebraska at Omaha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Healthy Young Adults, run by University of Nebraska 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 4 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 21 Aug 2026. 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 Farah Fallahtafi, PhD (4025543075, ffallahtafti@unomaha.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Real-Time Operation of the Robotic Ankle Exoskeleton Controller (time frame: through study completion, an average of 1 year). 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 21 Aug 2026.