Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees. (NCT06635655) | Clinical Trial Compass
RecruitingNot Applicable
Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.
France9 participantsStarted 2025-02-21
Plain-language 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.
Who can participate
Age range
18 Years – 84 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Goal Attainment Scale (GAS)
Timeframe: From enrollment to the end of treatment at 8 weeks