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Recruiting NCT06635655

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

Trial Parameters

Condition Lower Limb Amputation Above Knee (Injury)
Sponsor Proteor Group
Study Type OBSERVATIONAL
Phase N/A
Enrollment 9
Sex ALL
Min Age 18 Years
Max Age 84 Years
Start Date 2025-02-21
Completion 2026-09-30

Brief 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 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

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