Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT07204925

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

North Carolina State University

Raleigh, North Carolina, United States, 27695

Actively Recruiting

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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

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