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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2031-10-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Transfemoral Amputation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Participants Outcome Assessors

During the evaluation trial, the participants and evaluators are blinded on how the personalized parameters are decided.

Study Groups

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Tuning expert without RISE

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

Group Type ACTIVE_COMPARATOR

Manual personalization of the prosthetic leg by tuning experts

Intervention Type DEVICE

The control parameters of the prosthetic legs are decided by tuning experts based on their knowledge of the prosthetic leg prototypes and patients' response.

Tuning expert with RISE

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

Group Type ACTIVE_COMPARATOR

RISE guided personalization of prosthetic legs by tuning experts

Intervention Type DEVICE

The personalization procedure is conducted by tuning experts based on the recommendation of RISE system

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.

Group Type ACTIVE_COMPARATOR

RISE guided personalization of prosthetic legs by prosthetists

Intervention Type DEVICE

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

Interventions

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RISE guided personalization of prosthetic legs by tuning experts

The personalization procedure is conducted by tuning experts based on the recommendation of RISE system

Intervention Type 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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No