Study on a Prosthetic Foot With Adjustable Heel Height
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOtto Bock France SNC
About this trial
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.
The Taleo Adjust is a prosthetic foot with a hydraulic ankle that allows the user to adjust the heel height from 0 to 7 cm, depending on the type of shoe worn.
This study aims to evaluate the impact of an adjustable-heel-height foot on physical appearance and participation.
Eligibility criteria
Qualifiers
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
Disqualifiers
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 <22 or >28; mounting height less than 118 mm)
Trial design
Treatments tested in this trial
- Taleo Adjust
- The usual participant's foot
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov