Recruiting PHASE1 Transfemoral Amputation

New treatment option for Transfemoral Amputation

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

ClinicalTrials.gov ID: NCT07204925

What this study is testing

What it's testing
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.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75

You may be able to join if

  • 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

You likely can't join if

  • Have very short residual thighs (the length of the residual limb is \<15% of the length of the unimpaired limb)
  • Are \ 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...
  • Have any significant co-morbidity that interferes with the study (e.g. stroke, pacemaker placement, pain, etc.).

The study team makes the final eligibility decision.

Where it's taking place

  • Raleigh, North Carolina, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Raleigh, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.