Study on a Prosthetic Foot With Adjustable Heel Height
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOtto Bock France SNC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
Taleo Adjust
DeviceThe 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 participant's foot
DeviceThe usual foot of the participant is an Energy Storage and Return (ESR) prosthetic foot (no heel height adjustement)
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Taleo Adjust foot then usual footOther 2 interventions
Group B: Usual foot then taleo Adjust footOther 2 interventions
Trial outcomes
Primary outcomes
1
Prosthetic 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 daysSecondary outcomes
1
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 days2
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 days3
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 days4
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 daysSponsors and contacts
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Source ClinicalTrials.gov