North Carolina State University
Raleigh, North Carolina, 27695, United States
Location status: Recruiting
Location contact
He Huang, PhD
CONTACT
Laura Rohrbaugh
CONTACT
Ming Liu, PhD
SUB_INVESTIGATOR
NCT Number: NCT07204925
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).
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1
Raleigh, North Carolina, 27695, United States
Location status: Recruiting
He Huang, PhD
CONTACT
Laura Rohrbaugh
CONTACT
Ming Liu, PhD
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The personalization procedure is conducted by tuning experts based on the recommendation of RISE system
The control parameters of the prosthetic leg prototype is decided by prosthetists without detailed knowledge about the prosthetic leg with the help of developed RISE system
The control parameters of the prosthetic legs are decided by tuning experts based on their knowledge of the prosthetic leg prototypes and patients' response.
Time frame: During the visit arranged for personalization
Time needed to finish the personalization of the prosthetic leg
Time frame: 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
Time frame: 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.
Time frame: 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
Contact information is provided by the study sponsor or research team.
Laura Rohrbaugh, BS
CONTACT
Ming Liu, PhD
CONTACT
North Carolina State University
Other
Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Patient Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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