Magnetic Bead Tracking System for Below-Knee Amputees

This trial tests a new Magnetic Bead Tracking System designed to enhance prosthetic movement for individuals with below-knee amputations. The study aims to gather early data on the system's safety and effectiveness to help improve walking performance. It seeks participants who have had or will have a below-knee amputation and can walk at different speeds. As an Early Phase 1 trial, this research focuses on understanding how the system functions in people, offering participants the opportunity to be among the first to experience this innovative technology.

The trial information does not specify if you need to stop taking your current medications. However, if you are on corticosteroids, immune-suppressive therapy, or chemotherapy drugs, you must not have taken them within six months before the implant surgery.

In a previous study, researchers explored the safety and effectiveness of the Magnetic Bead Tracking System for individuals with below-knee amputations. Currently, detailed information remains limited as the research is in its early stages. Researchers are beginning to assess its safety for users.

As an early phase study, the primary focus is on determining the system's safety for humans. Researchers aim to identify any side effects or issues during use. Due to the preliminary nature of the research, they are monitoring everything closely.

Most treatments for below-knee amputees focus on enhancing prosthetic limb design or improving physical rehabilitation techniques. However, the Magnetic Bead Tracking System is unique because it integrates advanced tracking technology to precisely monitor and improve prosthetic gait performance. Unlike traditional methods, which rely heavily on subjective assessments and external observation, this system offers real-time feedback and quantifiable data on prosthetic use, potentially leading to more personalized and effective rehabilitation strategies. Researchers are excited about this trial because it could revolutionize how we assess and enhance mobility for amputees, providing insights that are not possible with current techniques.

Research has shown that the Magnetic Bead Tracking System, which participants in this trial will receive, might aid individuals with below-knee amputations by enhancing control and sensation of their prosthetic limbs. Previous studies suggest that this system uses magnetic fields to facilitate more natural communication between the brain and body with the prosthetic. This could make the prosthetic limb move and feel more like a natural part of the body. Although this technology is new and has limited data from human trials, early results are promising for improving prosthetic limb function.¹²³⁴⁵