Personalizing powered knee prostheses using reinforcement learning
Official title: Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Patient Study
Run by North Carolina State University · NCT07204925 · Data updated 2026-11-12
This trial will test whether a computer system called RISE can help clinicians tune powered knee prostheses faster and make them work better for people with above-knee (transfemoral) amputations.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | North Carolina State University Academic / other |
| Locations | 1 site (Raleigh, North Carolina) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | November 1, 2028 |
| Study ends | November 1, 2029 |
| Registry record updated | May 19, 2026 |
| Trial ID | NCT07204925 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are unilateral transfemoral amputees age 18–75 who are at least one year post-amputation, K-level 3 or higher, using a stable socket and leg for more than three months, can walk at least four minutes without assistive devices, and have no major recent residual-limb skin problems.
✕Probably not a fit
Patients with very short residual thighs, extreme body size (height <1.50 m or weight >116 kg), significant cognitive/visual/hearing impairments, recent major skin issues, or medical comorbidities that affect safety are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will compare a reinforcement-learning based Recommendation Interfacing System (RISE) against standard manual tuning to personalize an experimental powered prosthetic leg for unilateral transfemoral amputees. Participants will be fitted with a prototype robotic knee and randomized to personalization guided by RISE (performed by tuning experts or prosthetists) or to manual personalization by tuning experts. The primary measures are clinician tuning speed and short-term patient functional performance during walking tasks. This Phase 1 interventional trial focuses on feasibility and early functional outcomes in a clinical setting.
Why it matters
Potential benefit: If successful, the system could shorten fitting time, allow less-specialized clinicians to perform effective tuning, and improve walking performance for amputees.
How similar studies have gone: Laboratory and simulation work has shown promise for algorithmic and adaptive controllers, but clinical use of reinforcement-learning guided personalization for powered prostheses is still novel with limited clinical trial evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.).
Where it's running
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North Carolina State University
Raleigh, North Carolina, United States Recruiting
Study contacts
- Principal investigator: He (Helen) Huang, PhD — NC State University
- Study coordinator: Ming Liu, PhD
- Email: mliu10@ncsu.edu
- Phone: 9195158541
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Neural-controlled powered knee and ankle for people with above-knee amputation.
We will test whether a neural-controlled powered knee or ankle prosthesis helps people with above-knee (transfemoral) amputation walk more naturally and stably in everyday situations.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.