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NCT07204925 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Transfemoral Amputation, sponsored by North Carolina State University.

Recruiting
Registry status
Phase 1
Development phase
24
Enrollment target
1
Study location

NCT07204925 is a Phase 1 study of Transfemoral Amputation that is actively recruiting participants, run by North Carolina State University. The registered enrollment target is 24 participants, roughly in line with the 25-participant average among 8 other Transfemoral Amputation trials with a reported enrollment target. The trial reports 1 study location across 1 state.

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The verdict

NCT07204925, a Phase 1 study of Transfemoral Amputation, is actively recruiting participants, sponsored by North Carolina State University.

RECRUITING
Registry status
Phase 1
Development phase
24 participants
Enrollment target
1
Study location

Study 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).

Conditions Studied

Interventions

  • DEVICE RISE guided personalization of prosthetic legs by tuning experts
  • DEVICE RISE guided personalization of prosthetic legs by prosthetists
  • DEVICE Manual personalization of the prosthetic leg by tuning experts

Study Locations (1)

North Carolina

  • North Carolina State University - Raleigh

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2025-08-01
Est. Completion 2031-10-30
Phase Phase 1

Sponsor

North Carolina State University

19 total trials

What the Registry Record Tells You About NCT07204925

The ClinicalTrials.gov registry entry for NCT07204925 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 25-participant average among 8 other Transfemoral Amputation trials with a reported enrollment target. The listed sponsor is North Carolina State University, which has 19 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Transfemoral Amputation appearing as the primary indexed condition, and to 3 interventions - of which RISE guided personalization of prosthetic legs by tuning experts is the first listed.

NCT07204925 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT07204925 about?

NCT07204925 is a clinical study titled "Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1". 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 Recomme...

What is the current status of trial NCT07204925?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2025-08-01. Estimated completion is 2031-10-30.

What conditions does trial NCT07204925 study?

This clinical trial studies the following conditions: Transfemoral Amputation.

What interventions are being tested in trial NCT07204925?

The interventions under investigation include: RISE guided personalization of prosthetic legs by tuning experts (DEVICE), RISE guided personalization of prosthetic legs by prosthetists (DEVICE), Manual personalization of the prosthetic leg by tuning experts (DEVICE).

Who is sponsoring clinical trial NCT07204925?

This trial is sponsored by North Carolina State University, which has 19 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07204925 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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