Transfemoral Amputation
Conditions
Keywords
Powered prosthesis legs, control parameter personalization, reinforcement learning
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).
Interventions
DEVICERISE guided personalization of prosthetic legs by tuning experts
The personalization procedure is conducted by tuning experts based on the recommendation of RISE system
DEVICERISE 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
DEVICEManual 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.
Sponsors
North Carolina State University
Arizona State University
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
During the evaluation trial, the participants and evaluators are blinded on how the personalized parameters are decided.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total personalization time | During the visit arranged for personalization | Time needed to finish the personalization of the prosthetic leg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTMing Liu, PhD
CONTACTLaura Rohrbaugh, BS
PRINCIPAL_INVESTIGATORHe (Helen) Huang, PhD
NC State University
Outcome results
None listed