Evaluating how prosthetic systems affect mental workload in above-knee amputees
Official title: Evaluation of Medical Benefit of a New Prosthetic Leg Designed to Decrease Mental Workload in People With Lower Limb Amputation
Run by Proteor Group · NCT06635655 · Data updated 2026-11-12
This study is testing how different types of prosthetic legs affect the mental effort needed by people with above-knee amputations in their daily lives.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 84 Years |
| Sex | All |
| Enrollment | 9 (estimated) |
| Sponsor | Proteor Group Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Status | Recruiting |
| Started | February 21, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 9, 2025 |
| Trial ID | NCT06635655 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 18 to 84 with above-knee amputations who are using a compatible prosthetic knee and foot.
✕Probably not a fit
Patients who are bilateral amputees, hip disarticulated, or those who do not meet the eligibility criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the impact of different prosthetic systems on the mental workload experienced by individuals with above-knee amputations. By utilizing a multicentric, national approach, the study will measure differences in mental workload in both laboratory settings and daily life. Participants will be required to use specific prosthetic devices and have the capability to set therapeutic goals. The findings will help to understand user feedback regarding the functionalities of new generation prostheses.
Why it matters
Potential benefit: If successful, this study could lead to improved prosthetic designs that reduce mental workload for amputees, enhancing their quality of life.
How similar studies have gone: While there have been studies focusing on the biomechanics of prosthetics, this specific approach to assessing mental workload is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Multiple sites
Multiple Locations, France Recruiting
Study contacts
- Principal investigator: Isabelle Loiret, DR — UGECM Nord-Est, IRR, Centre Louis Pierquin
- Study coordinator: Renaud Urbinelli
- Email: rurbinelli@clin-experts.fr
- Phone: 0033658687286
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Microprocessor-controlled prosthetic knees for limited community ambulators with above-knee amputation.
This test will see if switching to a microprocessor-controlled prosthetic knee reduces fall-related health problems and improves walking speed, mobility, and quality of life for adults with above-knee amputations who are limited community ambulators compared with non-microprocessor knees.
-
Improving walking skills for lower limb prosthesis users on uneven terrain
This study tests a walking program for people using lower limb prostheses to see if training on uneven surfaces helps them walk better and feel more confident.
-
Comparing powered and mechanical prosthetic knees for K2-level amputees
This study is testing whether powered prosthetic knees work better than mechanical ones for K2-level amputees to help improve their mobility and make better choices for future prosthetic designs.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.