Actively Recruiting
Evaluation of Medical Benefit of a New Prosthetic Leg Designed to Decrease Mental Workload in People With Lower Limb Amputation
Led by Proteor Group · Updated on 2025-07-09
9
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the mental workload impact of new lower limb prosthetic systems in people with above-knee amputations. This observational study aims to understand how different prosthetic technologies affect users, both in laboratory settings and daily life, by measuring mental workload and related functional outcomes. Participants use above-knee prostheses with prosthetic knees and feet and are assessed using various scales and tests over an 8-week period. The study collects data on goal achievement, walking tests, balance confidence, prosthesis satisfaction, and incidents of stumbles or falls to evaluate prosthetic system impact. Throughout the study, participants will undergo evaluations at the start, 4 weeks, and 8 weeks, including functional walking tests and questionnaires. A smartphone is required for participation to help design therapeutic goals and track progress. The study follows participants for 8 weeks, monitoring outcomes like the Goal Attainment Scale as the primary measure of success.
CONDITIONS
Brief Title
Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 Goal Attainment Scale
- Having a smartphone
You will not qualify if you...
- Protected person
- Pregnant or breast-feeding lady
- Knee-to-ground height lower than 43 cm
- Weighing more than 125 kg
- Using prosthesis for less than 2 weeks
- Not covered by health insurance
- Aged less than 18 or more than 84 years
- Bilateral amputee or hip disarticulated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants are observed while using their above-knee prosthesis to assess mental workload and functional performance.
Visits at enrollment, 4 weeks, and 8 weeks
Trial Site Locations
Total: 1 location
1
Multiple sites
Multiple Locations, France
Actively Recruiting
Research Team
R
Renaud Urbinelli
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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