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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNorth Carolina State University

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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.).

Trial design

Treatments tested in this trial

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

Treatment groups

24 Participants
are divided into 3 treatment groups

Sponsors and collaborators

North Carolina State University

Lead sponsor

Arizona State University

Collaborator

University of North Carolina, Chapel Hill

Collaborator