RecruitingNCT06635655

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

Evaluation of Medical Benefit of a New Prosthetic Leg Designed to Decrease Mental Workload in People With Lower Limb Amputation


Sponsor

Proteor Group

Enrollment

9 participants

Start Date

Feb 21, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

New generation of lower limb prosthesis provide improved functionalities. They are usually studied in the scope of biomechanics, sometimes PROMs like quality of life. Following users feedback, it is desirable to better understand why and how mental workload is impacted by new technologies or features. This clinical investigation will try to measure a difference between different prosthetic systems, in lab and in daily life.


Eligibility

Min Age: 18 YearsMax Age: 84 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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

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Locations(1)

Multiple sites

Multiple Locations, France

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NCT06635655


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