NCT07214493

Study on a Prosthetic Foot With Adjustable Heel Height

Impact of a Prosthetic Foot With Adjustable Heel Height on Physical Appearance and Participation: a Randomized Crossover Trial.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Otto Bock France SNC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The amputation or absence of a lower limb affects both mobility and appearance, which can lead to restrictions in social, family, and professional participation. The choice of prosthetic components aims to compensate as effectively as possible for the functional and physical disability, in line with the patient's expectations and life plan. The prosthetic foot is a key component of the prosthesis. Most feet have a fixed heel height-most often around 10 to 15 mm-which requires users to always wear shoes with the same heel height, since prosthetic alignment, essential for harmonious and safe walking, is set accordingly. A fixed heel height is a significant constraint for many users who wish to wear different types of shoes for aesthetic reasons (e.g., city shoes or pumps for work or going out; flip-flops or flat ballet flats in summer), for safety reasons (e.g., boots for motorcycling or gardening), or to be able to walk barefoot (e.g., at home). The ability to choose one's clothing freely is an important aspect of coping with a physical disability. The Taleo Adjust is an energy-storing and energy-returning 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. Thanks to this articulation, prosthetic alignment is preserved and walking quality is not compromised. This study aims to evaluate the impact of an adjustable-heel-height foot on physical appearance and participation.

Conditions

• Lower Limb Amputation Above Knee
• Lower Limb Amputation Below Knee

Interventions

Type	Name	Description
DEVICE	Taleo Adjust	The Taleo Adjust foot is an energy-storage-and-return (ESR) prosthetic foot with a hydraulic ankle joint that allows an adjustable heel height from 0 to 7 cm.
DEVICE	The usual participant's foot	The usual foot of the participant is an Energy Storage and Return (ESR) prosthetic foot (no heel height adjustement)

Timeline

• Start date: 2025-10-08
• Primary completion: 2026-06-06
• Completion: 2026-06-06
• First posted: 2025-10-09
• Last updated: 2025-11-25

Locations

5 sites across 1 country: France