Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.
INCREMENT
Evaluation of Medical Benefit of a New Prosthetic Leg Designed to Decrease Mental Workload in People With Lower Limb Amputation
1 other identifier
observational
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2024
CompletedFirst Posted
Study publicly available on registry
October 10, 2024
CompletedStudy Start
First participant enrolled
February 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
July 9, 2025
July 1, 2025
1.6 years
October 4, 2024
July 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
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
Eligibility Criteria
Population usually living or receiving care around investigation centers
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Proteor Grouplead
Study Sites (1)
Multiple sites
Multiple Locations, France
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Laurine Calistri, MS
Proteor Group
- PRINCIPAL INVESTIGATOR
Isabelle Loiret, DR
UGECM Nord-Est, IRR, Centre Louis Pierquin
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2024
First Posted
October 10, 2024
Study Start
February 21, 2025
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
July 9, 2025
Record last verified: 2025-07