Study on a Prosthetic Foot With Adjustable Heel Height
- Conditions
- Lower Limb Amputation Above KneeLower Limb Amputation Below Knee
- Registration Number
- NCT07214493
- Lead Sponsor
- Otto Bock France SNC
- Brief 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 shoeing constraint whereas the person's ability to wear the clothing of their choice is an important aspect of compensating for physical disability.
The Taleo Adjust is a prosthetic foot with a hydraulic ankle allowing the patient to adjust the heel height of their foot from 0 to 7 cm, depending on the type of shoe worn.
This study aims to evaluate the impact of a foot with an adjustable heel height on the physical appearance and the participation.
- Detailed Description
The amputation or the absence of a lower limb impacts both the mobility and the appearance of the person, which can lead to a restriction of their social, family and professional participation. The choice of prosthetic components aims to compensate as best as possible for the functional and physical handicap, with regard to the expectations and life plan of the patient.
The prosthetic foot is an essential element of the prosthesis. Most feet have a fixed heel height, most often around 10 or 15 mm, which requires users to always wear shoes with the same heel height, since the alignments of the prosthesis, allowing harmonious and safe walking, are carried out on this basis.
A fixed heel height is a significant shoeing constraint for many patients who want to wear different types of shoes for aesthetic reasons (wearing city shoes or pumps to go to work or to go out, wearing flip-flops or flat ballet flats in the summer) or safety reasons (e.g. boots for riding a motorbike or going to the garden) or to be able to walk barefoot (e.g. at home). The person's ability to wear the clothing of their choice is an important aspect of compensating for physical disability.
The Taleo Adjust is an energy storage and returning prosthetic foot that has a hydraulic ankle allowing the patient to adjust the heel height of their foot from 0 to 7 cm, depending on the type of shoe worn. Because of this articulation, the alignments of the prosthesis are respected, and the quality of walking is not impacted.
This study aims to evaluate the impact of a foot with an adjustable heel height on the physical appearance and the participation.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Prosthetic Evaluation Questionnaire - Appearance scale (PEQ-AP) 30 days 5-items self-reported measure of the appearance domain. The participant rate each item with a mark on a 100 mm ligne. The score goes from 0 to 100, a higher score being positive.
- Secondary Outcome Measures
Name Time Method Patient Specific functional Scale (PSFS) 30 days Self-reported measure of participation through 3 to 5 self-selected activities that the participant cannot do or that he can do with difficulty. Participants will be asked to rate their ability to perform each activity on a numerical scale (0 being unable to perform the activity and 10 being able to fully perform the activity)
Psychosocial Impact of Assistive Device Scale (PIADS) 30 days 26-items questionnaire that assess the effects of an assistive device on functional independance, well-being and quality of life from the person's disability's point of view. Each item is noted on a 7-points likert scale going from -3 (maximum negative impact) to +3 (maximum positive impact).
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) 30 days 12-items self-reported measure on participant's satisfaction regarding the technology of the device and the services around the device. It allows the participant to express himself on the 3 most important criteria to him.
Visual Analog Scale (VAS) for the adequacy to life's project 30 days 11-levels numerical scale going for 0 (total dissatisfaction) to 10 (Total satisfaction), measuring the adequacy of the device on the participant life's project.
EuroQuol - 5 Dimensions - 5 Levels (EQ-5D-5L) 30 days Self-reported measure of health status composed of 5 dimensions: mobility, ability to self-care, ability to undertake usual activities, pain and disscomfort, anxiety and depression. Each dimension is rated on a 5-point scale.
Prosthetic Limb Users Survey of Mobility (PLUS-M) 30 days 12-items self-reportes measure of mobility as the ability to move intentionally and independantly from one place to another.
Socket Comfort Scale (SCS) 30 days 11-levels numerical scale going from 0 (the most uncomfortable socket) to 10 (the most comfortable socket), measuring the perceived comfort in the socket.
Trial Locations
- Locations (5)
CH Cornouaille
🇫🇷Concarneau, France
CHU Grenoble
🇫🇷Échirolles, France
IRR Louis Pierquin
🇫🇷Nancy, France
CRRF La Tourmaline
🇫🇷Saint-Herblain, France
Institut Merle d'Aubigné
🇫🇷Valenton, France
CH Cornouaille🇫🇷Concarneau, France