Study on a Prosthetic Foot With Adjustable Heel Height
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Taleo Adjust, The usual participant's foot.
- Who it may be relevant to
- Registry conditions: Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of a Prosthetic Foot With Adjustable Heel Height on Physical Appearance and Participation: a Randomized Crossover Trial.
Overview
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.
Interventions
- 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)
Primary outcome measures
- Prosthetic Evaluation Questionnaire - Appearance scale (PEQ-AP) [Time frame: 30 days]
Secondary outcome measures (7)
- Patient Specific functional Scale (PSFS) [Time frame: 30 days]
- Psychosocial Impact of Assistive Device Scale (PIADS) [Time frame: 30 days]
- Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) [Time frame: 30 days]
- Visual Analog Scale (VAS) for the adequacy to life's project [Time frame: 30 days]
- EuroQuol - 5 Dimensions - 5 Levels (EQ-5D-5L) [Time frame: 30 days]
- Prosthetic Limb Users Survey of Mobility (PLUS-M) [Time frame: 30 days]
- Socket Comfort Scale (SCS) [Time frame: 30 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 5 centers
- CH Cornouaille — Concarneau
- CHU Grenoble — Échirolles
- IRR Louis Pierquin — Nancy
- CRRF La Tourmaline — Saint-Herblain
- Institut Merle d'Aubigné — Valenton
Identifiers
NCT: NCT07214493 · BP-11-PT009