Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Device Feasibility
Masking
Double (Participant, Outcomes Assessor)
Masking Description
During the evaluation trial, the participants and evaluators are blinded on how the personalized parameters are decided.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Tuning expert without RISE
Tuning experts decide the control parameters based on their knowledge about the powered prosthetic device and patients' feedback
  • Device: Manual personalization of the prosthetic leg by tuning experts
    The control parameters of the prosthetic legs are decided by tuning experts based on their knowledge of the prosthetic leg prototypes and patients' response.
Active Comparator
Tuning expert with RISE
The control parameters of the prosthetic legs are decided by tuning experts with the help of the developed RISE system
  • Device: RISE guided personalization of prosthetic legs by tuning experts
    The personalization procedure is conducted by tuning experts based on the recommendation of RISE system
Active Comparator
Prosthetists with RISE
Control parameters of the prosthetic leg are decided by prosthetists, who are not familiar with the prosthetic leg prototype, with the RISE system.
  • Device: RISE guided personalization of prosthetic legs by prosthetists
    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

Recruiting Locations

North Carolina State University
Raleigh, North Carolina 27695
Contact:
He Huang, PhD
919-515-5218
hhuang11@ncsu.edu

More Details

Status
Recruiting
Sponsor
North Carolina State University

Study Contact

Ming Liu, PhD
9195158541
mliu10@ncsu.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.