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

North Carolina State University

Status and phase: Enrolling; Phase 1

Conditions: Transfemoral Amputation

Treatments: Device: Manual personalization of the prosthetic leg by tuning experts; Device: RISE guided personalization of prosthetic legs by prosthetists; Device: RISE guided personalization of prosthetic legs by tuning experts

Study type: Interventional

Funder types: Other

Identifiers

NCT07204925

28186

U.S. NIH 1R01HD116422-01A1 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Tuning expert without RISE

Active Comparator group

Description:

Tuning experts decide the control parameters based on their knowledge about the powered prosthetic device and patients' feedback

Treatment:

Device: Manual personalization of the prosthetic leg by tuning experts

Tuning expert with RISE

Active Comparator group

Description:

The control parameters of the prosthetic legs are decided by tuning experts with the help of the developed RISE system

Treatment:

Device: RISE guided personalization of prosthetic legs by tuning experts

Prosthetists with RISE

Active Comparator group

Description:

Control parameters of the prosthetic leg are decided by prosthetists, who are not familiar with the prosthetic leg prototype, with the RISE system.

Treatment:

Device: RISE guided personalization of prosthetic legs by prosthetists