Taleo Adjust prosthetic foot with adjustable heel height
Impact of a Prosthetic Foot With Adjustable Heel Height on Physical Appearance and Participation: a Randomized Crossover Trial.
NA · Otto Bock France SNC · NCT07214493
This trial will test whether the Taleo Adjust prosthetic foot with a hydraulic ankle helps adults with above- or below-knee amputations wear different shoes or go barefoot and improve appearance and participation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Otto Bock France SNC (industry) |
| Locations | 5 sites (Concarneau and 4 other locations) |
| Trial ID | NCT07214493 on ClinicalTrials.gov |
What this trial studies
The Taleo Adjust is an energy-storing and energy-returning prosthetic foot with a hydraulic ankle that lets users change heel height from 0 to 7 cm while preserving prosthetic alignment. Adult participants with above- or below-knee amputations who have used an ESR (energy storage and return) foot for at least three months will try the Taleo Adjust in place of their usual foot. The study measures effects on perceived physical appearance and participation with in-person fittings and follow-up at participating centers. Key exclusions include hip disarticulation, high-impact users, unstable residual limb or unsuitable socket, weight over 115 kg, incompatible foot sizes or mounting height, and patients whose current foot already has heel-height adjustment.
Who should consider this trial
Good fit: Ideal candidates are adults with a major lower-limb amputation who have used an ESR foot for at least three months, wish to wear different heel heights or go barefoot, and can be fitted within the Taleo Adjust technical limits (weight ≤115 kg, foot size 22–28, mounting height ≥118 mm) with a stable residual limb and socket.
Not a fit: Patients unlikely to benefit include high-impact athletes, those with hip disarticulation, unstable residual limbs or unsuitable sockets, people exceeding the product's weight or size limits, or anyone whose usual prosthetic foot already allows heel-height adjustment.
Why it matters
Potential benefit: If successful, the adjustable-heel foot could let users wear a wider range of shoe types or go barefoot without compromising alignment or walking quality, improving appearance and participation.
How similar studies have performed: Some prosthetic ankle and adjustable-geometry devices have shown promise for comfort and gait, but adjustable-heel-height energy-return feet like the Taleo Adjust are relatively new and have limited published controlled data on appearance and participation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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) * 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
Where this trial is running
Concarneau and 4 other locations
- CH Cornouaille — Concarneau, France (RECRUITING)
- CHU Grenoble — Échirolles, France (RECRUITING)
- IRR Louis Pierquin — Nancy, France (RECRUITING)
- CRRF La Tourmaline — Saint-Herblain, France (RECRUITING)
- Institut Merle d'Aubigné — Valenton, France (RECRUITING)
Study contacts
- Study coordinator: Aurelie LACROIX
- Email: aurelie.lacroix@ottobock.com
- Phone: 0033 (0)7 86 29 52 03
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.
Conditions: Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee, Lower limb amputation, Prosthetic foot, Adjustable heel height, Hydraulic ankle