Transfemoral AmputationPhase 1NCT07204925
Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1
A Phase 1 study testing RISE guided personalization of prosthetic legs by tuning experts, RISE guided personalization of prosthetic legs by prosthetists and Manual personalization of the prosthetic leg by tuning experts in people with Transfemoral Amputation, run by North Carolina State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to understand the feasibility and effectiveness of using reinforcement learning to personalize robotic prosthetic legs (an experimental prototype) for unilateral transfemoral amputees. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transfemoral Amputation
- What is being tested?
- RISE guided personalization of prosthetic legs by tuning experts, RISE guided personalization of prosthetic legs by prosthetists and Manual personalization of the prosthetic leg by tuning experts
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 1 Nov 2029
- Phase
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral transfemoral amputees between 18-75 with K level three or higher
- More than one year after amputation
- Using current prosthetic socket and leg for more than three months
- No major skin issues on the residual limb for more than six months
- Can walk for more than 4 minutes continuously without any other assistive devices
Who cannot join
- Have very short residual thighs (the length of the residual limb is <15% of the length of the unimpaired limb)
- Are <1.50m in height or >116Kg in weight (who would not fit our prosthesis or the PowerKnee)
- Have cognitive, visual, audio impairments that would affect their ability to give informed consent or to follow simple Instructions during the experiments
- Have any significant co-morbidity that interferes with the study (e.g. stroke, pacemaker placement, pain, etc.).
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, 1 recruiting
- Recruiting
North Carolina State University
Raleigh, North Carolina, 27695
He Huang, PhD, 919-515-5218, hhuang11@ncsu.edu
Laura Rohrbaugh, 919-513-3840, lasmith6@ncsu.edu
About this study
Official title: Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Patient Study
The goal of this clinical trial is to understand the feasibility and effectiveness of using reinforcement learning to personalize robotic prosthetic legs (an experimental prototype) for unilateral transfemoral amputees. The main questions it aims to answer are:
- With the developed RL-based Recommendation Interfacing System (RISE), clinicians are able to personalize prosthetic legs faster compared with existing manual personalization procedures.
- With the developed RL-based Recommendation Interfacing System (RISE), clinicians are able to personalize prosthetic legs without detailed knowledge about how the prosthetic legs are controlled.
- Patients perform better when the prosthetic legs are personalized with RISE system compared with the ones personalized manually Researchers will compare two arms (RISE guided personalization and manual personalization) to see if the tuning speed will increase and if patients can perform better.
Participants will go through the standard prosthetic fitting procedures, such as alignment adjustment, then they will experience repeated prosthesis personalization procedures conducted by tuning specialists without RISE, tuning specialists with RISE, and prosthetists (without tuning expertise) with RISE on different types of terrains. In the end, the participants will go through a testing trial, in which they will experience the prototype personalized through the three different approaches without knowing how the control parameters are decided. Their walking performance will be recorded. It is expected that the participants will visit the testing site 8 times, which including alignment (1 visit), three personalization procedures (twice for each), and one testing trial (1-2 visits).
- Conditions
- Transfemoral Amputation
- Being tested
- RISE guided personalization of prosthetic legs by tuning experts, RISE guided personalization of prosthetic legs by prosthetists, Manual personalization of the prosthetic leg by tuning experts
- Keywords
- Powered prosthesis legs, control parameter personalization, reinforcement learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RISE guided personalization of prosthetic legs by tuning expertsDevice
The personalization procedure is conducted by tuning experts based on the recommendation of RISE system
RISE guided personalization of prosthetic legs by prosthetistsDevice
The control parameters of the prosthetic leg prototype is decided by prosthetists without detailed knowledge about the prosthetic leg with the help of developed RISE system
Manual personalization of the prosthetic leg by tuning expertsDevice
The control parameters of the prosthetic legs are decided by tuning experts based on their knowledge of the prosthetic leg prototypes and patients' response.
| Study group | Role | What they receive |
|---|---|---|
| Tuning expert without RISE | Active comparator | Tuning experts decide the control parameters based on their knowledge about the powered prosthetic device and patients' feedback Receives: Device: Manual personalization of the prosthetic leg by tuning experts |
| Tuning expert with RISE | Active comparator | The control parameters of the prosthetic legs are decided by tuning experts with the help of the developed RISE system Receives: Device: RISE guided personalization of prosthetic legs by tuning experts |
| Prosthetists with RISE | Active comparator | Control parameters of the prosthetic leg are decided by prosthetists, who are not familiar with the prosthetic leg prototype, with the RISE system. Receives: Device: RISE guided personalization of prosthetic legs by prosthetists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total personalization time
Time needed to finish the personalization of the prosthetic leg
Measured: During the visit arranged for personalization
Secondary outcomes (3)
Walking speed
The walking speed of the participants when the prosthetic leg is personalized using one of the three personalization procedures
Measured: During the last visit for evaluation
Step length
Length of step when the participant walking with the prosthetic leg, of which control parameters are decided by one of the three personalization approaches.
Measured: During the last visit for evaluation
foot elevation
Maximum height of the foot during swing when the control parameters of the prosthetic legs are decided by one of the three personalization procedures
Measured: during the last visit for evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Aug 2025
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfemoral AmputationStudies 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 1
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Carolina State University
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University, University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, He Huang, North Carolina State University
- Investigators
- He (Helen) Huang, PhD, Principal investigator, NC State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204925
- Sponsor's protocol ID
- 28186
- Other IDs
- U.S. NIH 1R01HD116422-01A1
- Status last verified
- May 2026
- First submitted
- 2 Sep 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Based on the requirement of local IRB, we will not share IPD information with other researchers and only deidentified data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Patient Study
- ClinicalTrials.gov ID
- NCT07204925
- Acronym / sponsor ID
- 28186
- Conditions
- Transfemoral Amputation
- Keywords
- Powered prosthesis legs, control parameter personalization, reinforcement learning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- North Carolina State UniversityUniversity, hospital or other
- Collaborators
- Arizona State University, University of North Carolina, Chapel Hill
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 2 Oct 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.
The goal of this clinical trial is to understand the feasibility and effectiveness of using reinforcement learning to personalize robotic prosthetic legs (an experimental prototype) for unilateral transfemoral amputees. The main questions it aims to answer are:
- With the developed RL-based Recommendation Interfacing System (RISE), clinicians are able to personalize prosthetic legs faster compared with existing manual personalization procedures.
- With the developed RL-based Recommendation Interfacing System (RISE), clinicians are able to personalize prosthetic legs without detailed knowledge about how the prosthetic legs are controlled.
- Patients perform better when the prosthetic legs are personalized with RISE system compared with the ones personalized manually Researchers will compare two arms (RISE guided personalization and manual personalization) to see if the tuning speed will increase and if patients can perform better.
Participants will go through the standard prosthetic fitting procedures, such as alignment adjustment, then they will experience repeated prosthesis personalization procedures conducted by tuning specialists without RISE, tuning specialists with RISE, and prosthetists (without tuning expertise) with RISE on different types of terrains. In the end, the participants will go through a testing trial, in which they will experience the prototype personalized through the three different approaches without knowing how the control parameters are decided. Their walking performance will be recorded. It is expected that the participants will visit the testing site 8 times, which including alignment (1 visit), three personalization procedures (twice for each), and one testing trial (1-2 visits).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tuning expert without RISE | Active comparator | Device: Manual personalization of the prosthetic leg by tuning expertsTuning experts decide the control parameters based on their knowledge about the powered prosthetic device and patients' feedback |
| Tuning expert with RISE | Active comparator | Device: RISE guided personalization of prosthetic legs by tuning expertsThe control parameters of the prosthetic legs are decided by tuning experts with the help of the developed RISE system |
| Prosthetists with RISE | Active comparator | Device: RISE guided personalization of prosthetic legs by prosthetistsControl parameters of the prosthetic leg are decided by prosthetists, who are not familiar with the prosthetic leg prototype, with the RISE system. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral transfemoral amputees between 18-75 with K level three or higher
- More than one year after amputation
- Using current prosthetic socket and leg for more than three months
- No major skin issues on the residual limb for more than six months
- Can walk for more than 4 minutes continuously without any other assistive devices
Key exclusion criteria (4 listed)
- Have very short residual thighs (the length of the residual limb is <15% of the length of the unimpaired limb)
- Are <1.50m in height or >116Kg in weight (who would not fit our prosthesis or the PowerKnee)
- Have cognitive, visual, audio impairments that would affect their ability to give informed consent or to follow simple Instructions during the experiments
- Have any significant co-morbidity that interferes with the study (e.g. stroke, pacemaker placement, pain, etc.).
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 |
|---|---|---|
| RISE guided personalization of prosthetic legs by tuning expertsThe personalization procedure is conducted by tuning experts based on the recommendation of RISE system | Device | Tuning expert with RISE |
| RISE guided personalization of prosthetic legs by prosthetistsThe control parameters of the prosthetic leg prototype is decided by prosthetists without detailed knowledge about the prosthetic leg with the help of developed RISE system | Device | Prosthetists with RISE |
| Manual personalization of the prosthetic leg by tuning expertsThe control parameters of the prosthetic legs are decided by tuning experts based on their knowledge of the prosthetic leg prototypes and patients' response. | Device | Tuning expert without RISE |
Primary outcome
Total personalization time
Time frame: During the visit arranged for personalization
Time needed to finish the personalization of the prosthetic leg
3 secondary outcomes
Walking speed
Time frame: During the last visit for evaluation
Step length
Time frame: During the last visit for evaluation
foot elevation
Time frame: during the last visit for evaluation
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 19 May 2026.
- Individual participant dataSharing planned: No. Based on the requirement of local IRB, we will not share IPD information with other researchers and only deidentified data will be shared.
Related trials for Transfemoral Amputation
Enrolling by invitation
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
Transfemoral Amputees
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Active, not recruiting
Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
Amputation, Transfemoral Amputation
Not yet recruiting
Impact of Anterior Load Carriage on Gait in Individuals With Transfemoral Amputation
Unilateral Transfemoral Amputation in Prosthetic Users
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.
He (Helen) Huang, PhD principal investigator
NC State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RISE guided personalization of prosthetic legs by tuning experts, RISE guided personalization of prosthetic legs by prosthetists and Manual personalization of the prosthetic leg by tuning experts in people with Transfemoral Amputation, run by North Carolina State University 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 May 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Ming Liu, PhD (9195158541, mliu10@ncsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total personalization time (time frame: During the visit arranged for personalization). 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 19 May 2026.