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

Proteor Group

Status: Enrolling

Conditions: Lower Limb Amputation Above Knee (Injury)

Study type: Observational

Funder types: Industry

Identifiers

NCT06635655

2023-A00581-44

Details and patient eligibility

About

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.

Full description

Multicentric, national, observational, prospective study, using AB type SCED.

Enrollment: 9 estimated patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

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