Study on a Prosthetic Foot With Adjustable Heel Height (ADJUST)

Otto Bock Healthcare (Ottobock)

Status: Enrolling

Conditions: Lower Limb Amputation Below Knee; Lower Limb Amputation Above Knee

Treatments: Device: Taleo Adjust; Device: The usual participant's foot

Study type: Interventional

Funder types: Industry

Identifiers

NCT07214493

BP-11-PT009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Taleo Adjust foot then usual foot

Other group

Description:

The participant is first fitted with the Taleo Adjust foot for 30 days, then is fitted with their usual foot for 30 days.

Treatment:

Device: The usual participant's foot

Device: Taleo Adjust

Usual foot then taleo Adjust foot

Other group

Description:

The participant is first fitted with their usual foot for 30 days, then fitted with the Taleo Adjust foot for 30 days

Treatment:

Device: The usual participant's foot

Device: Taleo Adjust