Actively Recruiting
Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1
Led by North Carolina State University · Updated on 2025-10-02
24
Participants Needed
1
Research Sites
325 weeks
Total Duration
On this page
Sponsors
N
North Carolina State University
Lead Sponsor
A
Arizona State University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral transfemoral amputees between 18-75 years old 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
You will not qualify if you...
- Have very short residual thighs (residual limb less than 15% of the unimpaired limb length)
- Height less than 1.50m or weight greater than 116Kg (not fitting the prosthesis or PowerKnee)
- Have cognitive, visual, or audio impairments affecting informed consent or ability to follow instructions
- Have any significant co-morbidity interfering with the study (e.g., stroke, pacemaker, pain)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
North Carolina State University
Raleigh, North Carolina, United States, 27695
Actively Recruiting
Research Team
M
Ming Liu, PhD
CONTACT
L
Laura Rohrbaugh, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here