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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
30
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.
The usual foot of the participant is an Energy Storage and Return (ESR) prosthetic foot (no heel height adjustement)
CH Cornouaille
Concarneau, France
RECRUITINGCHU Grenoble
Échirolles, France
RECRUITINGIRR Louis Pierquin
Nancy, France
RECRUITINGCRRF La Tourmaline
Saint-Herblain, France
RECRUITINGInstitut Merle d'Aubigné
Valenton, France
RECRUITINGProsthetic Evaluation Questionnaire - Appearance scale (PEQ-AP)
A 5-item self-reported measure of the appearance domain. The participant rates each item by marking a 100-mm line. Scores range from 0 to 100, with higher scores indicating a more positive perception.
Time frame: 30 days
Patient Specific functional Scale (PSFS)
A self-reported measure of participation based on 3 to 5 self-selected activities that the participant cannot perform or can perform only with difficulty. Participants will be asked to rate their ability to perform each activity on a numerical scale from 0 (unable to perform the activity) to 10 (able to fully perform the activity).
Time frame: 30 days
Psychosocial Impact of Assistive Device Scale (PIADS)
A 26-item questionnaire that assesses the effects of an assistive device on functional independence, well-being, and quality of life from the perspective of the person's disability. Each item is rated on a 7-point Likert scale ranging from -3 (maximum negative impact) to +3 (maximum positive impact).
Time frame: 30 days
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
A 12-item self-reported measure of the participant's satisfaction with the device's technology and the services associated with it. An average satisfaction rating can be calculated on a scale from 1 to 5, with 1 = "Not at all satisfied" and 5 = "Very satisfied". A higher score indicates greater satisfaction. It also allows the participant to express the three criteria that are most important to them.
Time frame: 30 days
Visual Analog Scale (VAS) for the adequacy to life's project
An 11-level numerical scale ranging from 0 (total dissatisfaction) to 10 (total satisfaction), measuring how well the device aligns with the participant's life project
Time frame: 30 days
EuroQuol - 5 Dimensions - 5 Levels (EQ-5D-5L)
A self-reported measure of health status composed of five dimensions: mobility, self-care, ability to perform usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-point scale. A utility index, which is a single value derived from a patient's responses to these dimensions, can be calculated using a population-specific value set, typically ranging from 0 (death) to 1 (perfect health). Health status is also expressed using the EQ-VAS (Visual Analog Scale). The EQ-VAS records the patient's self-assessment of health on a vertical visual analog scale, ranging from 0 "The worst health you could imagine" to 100 "The best health you could imagine."
Time frame: 30 days
Prosthetic Limb Users Survey of Mobility (PLUS-M)
A 12-items self-reported measure of mobility as the ability to move intentionally and independantly from one place to another. Questions cover movements that range from basic ambulation to complex activities . Response options going from 1 (unable to do) to 5 (without any difficulty), reflecting the degree of difficulty with which respondents report they can perform these activities. The PLUS-M™ 12-item short form provides a T-score ranging from 21.8 to 71.4, with higher scores indicating better mobility.
Time frame: 30 days
Socket Comfort Scale (SCS)
A 11-levels numerical scale going from 0 (the most uncomfortable socket) to 10 (the most comfortable socket), measuring the perceived comfort in the socket.
Time frame: 30 days
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