INCREMENT
Evaluation of Medical Benefit of a New Prosthetic Leg Designed to Decrease Mental Workload in People With Lower Limb Amputation
Sponsor study identifier
observational
9
1 country
1
Study Start
February 21, 2025
Actual (reported)Primary Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 4, 2024
Actual (reported)October 10, 2024
Actual (reported)February 21, 2025
Actual (reported)September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Goal Attainment Scale (GAS)
Scale from -3 to +2. The higher the better. -3 being a deterioration, -2 being the baseline, 0 the objective, +2 the maximum
From enrollment to the end of treatment at 8 weeks
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
Population usually living or receiving care around investigation centers
Multiple sites
Multiple Locations, France
Laurine Calistri, MS
Proteor Group
Isabelle Loiret, DR
UGECM Nord-Est, IRR, Centre Louis Pierquin
First Submitted
October 4, 2024
First Posted
October 10, 2024
Study Start
February 21, 2025
Actual (reported)Primary Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The CYBERnetic Lower Limb Cocognitive Ortho-prosthesis Plus Plus, 1st Clinical Study (CLs++)
Contact the study team to confirm eligibility.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 9, 2025
Record last verified: 2025-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: