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

Proteor Group1 site in 1 country9 target enrollmentFebruary 21, 2025

ConditionsLower Limb Amputation Above Knee (Injury)

Overview

Phase: N/A
Intervention: Not specified
Conditions: Lower Limb Amputation Above Knee (Injury)
Sponsor: Proteor Group
Enrollment: 9
Locations: 1
Primary Endpoint: Goal Attainment Scale (GAS)
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

February 21, 2025

End Date

December 31, 2026

Last Updated

9 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Proteor Group

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Goal Attainment Scale (GAS)

Time Frame: From enrollment to the end of treatment at 8 weeks

Scale from -3 to +2. The higher the better. -3 being a deterioration, -2 being the baseline, 0 the objective, +2 the maximum

Secondary Outcomes

L-test and Dual-task L-test(Initial visit, at 4 weeks, and at 8 weeks)
Two-minute walk test (2MWT) and 2MWT in divided attention(Initial visit, at 4 weeks, and at 8 weeks)
Activity Balance Confidence Scale (ABC-scale)(at 4 weeks, and at 8 weeks)
Prosthesis Evaluation Questionnaire (PEQ-A)(at 4 weeks, and at 8 weeks)
Stumbles and falls(at 4 weeks, and at 8 weeks)