BridgeMD
New treatment option for Lower Limb Amputation Above Knee
Official title Study on a Prosthetic Foot With Adjustable Heel Height
ClinicalTrials.gov ID: NCT07214493
What this study is testing
- What it's testing
- Most prosthetic feet have a fixed heel height, which requires users to always wear shoes with the same heel height. A fixed heel height is a significant constraint, whereas the ability to choose one's clothing freely is an important aspect of coping with a physical disability.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patient with a major lower limb amputation whose life project includes:
- movement in buildings other than the home (ICF d4601),
- movement outside the home and other buildings (ICF d4602),
- and other specified activities related to movement in other various places (ICF d4608).
- Patient who has been using an Enregy storage and Return (ESR) foot for at least 3 months
You likely can't join if
- Patient with a high impact level (e.g.: sport)
- Patient with hip disarticulation or equivalent
- Patient with an unstabilised residual limb and/or an unsuitable socket
- Patient who cannot be fitted with a Taleo Adjust foot due to the technical characteristics of the product (user weight greater than 115kg; required...
- Patient whose usual foot has a heel height adjustment system
- Patient unavailable for the duration of the study and/or unable to understand the instructions and/or answer questionnaires in French
See the full eligibility criteria
- Adult patient with a major lower limb amputation whose life project includes:
- movement in buildings other than the home (ICF d4601),
- movement outside the home and other buildings (ICF d4602),
- and other specified activities related to movement in other various places (ICF d4608).
- Patient who has been using an Enregy storage and Return (ESR) foot for at least 3 months
- Patient who wishes to walk with shoes with different heel heights, and/or barefoot
- Patient with a high impact level (e.g.: sport)
- Patient with hip disarticulation or equivalent
- Patient with an unstabilised residual limb and/or an unsuitable socket
- Patient who cannot be fitted with a Taleo Adjust foot due to the technical characteristics of the product (user weight greater than 115kg; required foot size \ 28; mounting height less than 118 mm)
- Patient whose usual foot has a heel height adjustment system
- Patient unavailable for the duration of the study and/or unable to understand the instructions and/or answer questionnaires in French
- Patient already participating in another study
- Patient in an emergency situation or pregnant woman
The study team makes the final eligibility decision.
Where it's taking place
- Concarneau, France
- Échirolles, France
- Nancy, France
- Saint-Herblain, France
- Valenton, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Concarneau, France; Échirolles, France; Nancy, France; Saint-Herblain, France; Valenton, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.