Evaluating how prosthetic systems affect mental workload in above-knee amputees
Evaluation of Medical Benefit of a New Prosthetic Leg Designed to Decrease Mental Workload in People With Lower Limb Amputation
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 |
|---|---|
| Enrollment | 9 (estimated) |
| Ages | 18 Years to 84 Years |
| Sex | All |
| Sponsor | Proteor Group Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT06635655 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 84 with above-knee amputations who are using a compatible prosthetic knee and foot.
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.
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 performed: While there have been studies focusing on the biomechanics of prosthetics, this specific approach to assessing mental workload is relatively novel.
Eligibility criteria
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 this trial is running
Multiple Locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.