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

Not Applicable

Recruiting

• Conditions: Transfemoral Amputation

• Registration Number: NCT07204925
• Lead Sponsor: North Carolina State University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2025-08-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2031-07-31
• Study Completion: 2031-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Unilateral transfemoral amputees between 18-75 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

Exclusion Criteria

• Have very short residual thighs (the length of the residual limb is <15% of the length of the unimpaired limb)
• Are <1.50m in height or >116Kg in weight (who would not fit our prosthesis or the PowerKnee)
• Have cognitive, visual, audio impairments that would affect their ability to give informed consent or to follow simple Instructions during the experiments
• Have any significant co-morbidity that interferes with the study (e.g. stroke, pacemaker placement, pain, etc.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Total personalization time	During the visit arranged for personalization	Time needed to finish the personalization of the prosthetic leg

Secondary Outcome Measures

Name	Time	Method
Walking speed	During the last visit for evaluation	The walking speed of the participants when the prosthetic leg is personalized using one of the three personalization procedures
Step length	During the last visit for evaluation	Length of step when the participant walking with the prosthetic leg, of which control parameters are decided by one of the three personalization approaches.
foot elevation	during the last visit for evaluation	Maximum height of the foot during swing when the control parameters of the prosthetic legs are decided by one of the three personalization procedures

Trial Locations

Locations (1)

North Carolina State University; 🇺🇸 Raleigh, North Carolina, United States