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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: Recruiting Phase 1 study of Transfemoral Amputation, sponsored by North Carolina State University.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Time needed to finish the personalization of the prosthetic leg
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
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2025-08-01 |
| Est. Completion | 2031-10-30 |
| Phase | Phase 1 |
What NCT07204925 shows while recruiting
NCT07204925 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, roughly in line with the 25-participant average among 8 other Transfemoral Amputation trials with a reported enrollment target.
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT07204925's enrollment target sits among peer trials
24 4th of 8 higher than 5 of 8 other Transfemoral Amputation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Transfemoral Amputation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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