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RECRUITING
NCT07204925
PHASE1

Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1

Sponsor: North Carolina State University

View on ClinicalTrials.gov

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. 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).

Official title: Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Patient Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-08-01

Completion Date

2031-10-30

Last Updated

2025-10-02

Healthy Volunteers

No

Interventions

DEVICE

RISE guided personalization of prosthetic legs by tuning experts

The personalization procedure is conducted by tuning experts based on the recommendation of RISE system

DEVICE

RISE guided personalization of prosthetic legs by prosthetists

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

DEVICE

Manual personalization of the prosthetic leg by tuning experts

The control parameters of the prosthetic legs are decided by tuning experts based on their knowledge of the prosthetic leg prototypes and patients' response.

Locations (1)

North Carolina State University

Raleigh, North Carolina, United States