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Search / Trial NCT06635655

Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.

Launched by PROTEOR GROUP · Oct 8, 2024

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

Microprocessor Controlled Lower Limb Prosthesis Mental Workload

ClinConnect Summary

This clinical trial is looking at how different types of prosthetic systems affect the mental workload of people who have had an above-knee amputation. Essentially, it aims to understand how using new prosthetic technology influences the mental effort required for daily activities. Researchers want to see if there's a difference in this mental workload when using various prosthetic devices, both in controlled lab settings and in real-life situations.

To participate, individuals need to be aged between 18 and 84, have an above-knee amputation, and currently use a prosthetic knee and foot. They should also be able to set personal goals for their rehabilitation and have a smartphone. Participants can expect to share their experiences and help researchers gather important information that could improve future prosthetic designs. It's important to note that those who are pregnant, weigh more than 125 kg, or have certain other medical conditions may not be eligible for this study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • above-knee lower limb amputation
  • using an above-knee prosthesis with prosthetic knee and foot
  • eligible to use Synsys
  • able to design therapeutic objectives for the GAS
  • having a smartphone
  • Exclusion Criteria:
  • protected person
  • pregnant or breast-feeding lady
  • knee-to-ground height lower than 43cm
  • weighting more than 125kg
  • using their prosthesis for less than 2 weeks
  • not covered by health insurance
  • aged less than 18 or more than 84 years old
  • bilateral amputee or hip disarticulated

About Proteor Group

Proteor Group is a leading clinical trial sponsor dedicated to advancing healthcare through innovative research and development. With a focus on biopharmaceuticals and medical devices, Proteor Group specializes in designing and executing clinical trials that adhere to the highest regulatory standards. Their experienced team collaborates with healthcare professionals, regulatory agencies, and industry partners to ensure robust trial methodologies and optimal patient safety. Committed to transparency and ethical practices, Proteor Group strives to deliver impactful solutions that enhance patient outcomes and contribute to the evolution of medical science.

Locations

Multiple Locations, , France

Patients applied

0 patients applied

Trial Officials

Laurine Calistri, MS

Study Director

Proteor Group

Isabelle Loiret, DR

Principal Investigator

UGECM Nord-Est, IRR, Centre Louis Pierquin

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported