Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
ID07204925

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

Led by North Carolina State University · Updated on 2026-05-19

24

Participants Needed

1

Research Sites

52 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

Researchers are evaluating the use of reinforcement learning to personalize robotic prosthetic legs for adults with unilateral transfemoral amputation. This clinical trial aims to determine if the RL-based Recommendation Interfacing System (RISE) allows clinicians to personalize prosthetic legs faster and without detailed control knowledge compared to manual methods. The study compares patient performance and personalization speed across different personalization approaches. Participants will experience three personalization methods: tuning experts manually adjusting prosthetic controls, tuning experts using the RISE system to guide adjustments, and prosthetists without tuning expertise using RISE. The study involves standard prosthetic fitting procedures like alignment adjustment, followed by multiple personalization sessions on different terrains. Participants will complete a testing trial where walking performance with each personalization approach is measured. Participants are expected to visit the testing site about eight times: one visit for alignment, three personalization procedures repeated twice each, and one or two visits for the final testing trial. Researchers will record outcomes such as total personalization time during visits, walking speed, step length, and foot elevation during evaluation visits. Safety and adherence will be monitored throughout the study period ending in November 2029.

CONDITIONS

Brief 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 and 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 continuously for more than 4 minutes without other assistive devices
Not Eligible

You will not qualify if you...

  • Very short residual thighs (less than 15% of the length of the unimpaired limb)
  • Height under 1.50 meters or weight over 116 kilograms
  • Cognitive, visual, or hearing impairments affecting consent or instructions
  • Significant co-morbidities interfering with the study such as stroke, pacemaker, or pain

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - During the visit arranged for personalization

Participants receive different personalization procedures for their computerized lower limb prostheses. These procedures include manual personalization by tuning experts, personalization guided by the RISE system with tuning experts, and personalization guided by the RISE system with prosthetists.

1 to 3 visits depending on assigned personalization method

Post-operative Follow-up

Duration - Up to 1 week after personalization

Participants are evaluated for walking speed, step length, and foot elevation after personalization to assess prosthetic performance.

1 visit (in-person)

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

L

Laura Rohrbaugh, BS

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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