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Recruiting NCT07204925

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

Phase I Interventional Transfemoral Amputation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Transfemoral Amputation. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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
  • 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
  • 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.

Primary outcome measures

  • Total personalization time [Time frame: During the visit arranged for personalization]
Secondary outcome measures (3)
  • Walking speed [Time frame: During the last visit for evaluation]
  • Step length [Time frame: During the last visit for evaluation]
  • foot elevation [Time frame: during the last visit for evaluation]

Eligibility criteria

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.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • North Carolina State University — Raleigh

Identifiers

NCT: NCT07204925 · 28186 · U.S. NIH 1R01HD116422-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗