Lower Limb Amputation Above KneeADJUSTNCT07214493
Study on a Prosthetic Foot With Adjustable Heel Height
A study testing Taleo Adjust and The usual participant's foot in people with Lower Limb Amputation Above Knee and Lower Limb Amputation Below Knee, run by Otto Bock France SNC at 5 sites in France.
Trial 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 constraint, whereas the ability to choose one's clothing freely is an important aspect of coping with a physical disability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
- What is being tested?
- Taleo Adjust and The usual participant's foot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesFrance
- Study dates
- 8 Oct 2025to 6 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CH Cornouaille
Concarneau
- Recruiting
CHU Grenoble
Échirolles
- Recruiting
IRR Louis Pierquin
Nancy
- Recruiting
CRRF La Tourmaline
Saint-Herblain
- Recruiting
Institut Merle d'Aubigné
Valenton
About this study
Official title: Impact of a Prosthetic Foot With Adjustable Heel Height on Physical Appearance and Participation: a Randomized Crossover 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.
Read the 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.
- Being tested
- Taleo Adjust, The usual participant's foot
- Keywords
- Lower limb amputation, Prosthetic foot, Adjustable heel height, Hydraulic ankle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taleo AdjustDevice
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 participant's footDevice
The usual foot of the participant is an Energy Storage and Return (ESR) prosthetic foot (no heel height adjustement)
| Study group | Role | What they receive |
|---|---|---|
| Taleo Adjust foot then usual foot | Other | The participant is first fitted with the Taleo Adjust foot for 30 days, then is fitted with their usual foot for 30 days. Receives: Device: Taleo Adjust; Device: The usual participant's foot |
| Usual foot then taleo Adjust foot | Other | The participant is first fitted with their usual foot for 30 days, then fitted with the Taleo Adjust foot for 30 days Receives: Device: Taleo Adjust; Device: The usual participant's foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start8 Oct 2025
- Primary completion6 Jun 2026 (estimated)
- Study completion6 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation Above KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otto Bock France SNC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brice LAVRARD, Dr., Study chair, Institut Merle d'Aubigné - VALENTONIsabelle LOIRET, Study chair, IRR Louis Pierquin - NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214493
- Sponsor's protocol ID
- BP-11-PT009
- Acronym
- ADJUST
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Prosthetic Foot With Adjustable Heel Height on Physical Appearance and Participation: a Randomized Crossover Trial.
- ClinicalTrials.gov ID
- NCT07214493
- Acronym / sponsor ID
- ADJUST / BP-11-PT009
- Keywords
- Lower limb amputation, Prosthetic foot, Adjustable heel height, Hydraulic ankle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Otto Bock France SNCIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 6 Jun 2026 (estimated)
- Study completion
- 6 Jun 2026 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taleo Adjust foot then usual foot | Other | Device: Taleo Adjust, Device: The usual participant's footThe participant is first fitted with the Taleo Adjust foot for 30 days, then is fitted with their usual foot for 30 days. |
| Usual foot then taleo Adjust foot | Other | Device: Taleo Adjust, Device: The usual participant's footThe participant is first fitted with their usual foot for 30 days, then fitted with the Taleo Adjust foot for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taleo AdjustThe 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 | Taleo Adjust foot then usual foot, Usual foot then taleo Adjust foot |
| The usual participant's footThe usual foot of the participant is an Energy Storage and Return (ESR) prosthetic foot (no heel height adjustement) | Device | Taleo Adjust foot then usual foot, Usual foot then taleo Adjust foot |
Primary outcome
Prosthetic Evaluation Questionnaire - Appearance scale (PEQ-AP)
Time frame: 30 days
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brice LAVRARD, Dr. study chair
Institut Merle d'Aubigné - VALENTON
Isabelle LOIRET study chair
IRR Louis Pierquin - NANCY
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taleo Adjust and The usual participant's foot in people with Lower Limb Amputation Above Knee and Lower Limb Amputation Below Knee, run by Otto Bock France SNC at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurelie LACROIX (0033 (0)7 86 29 52 03, aurelie.lacroix@ottobock.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthetic Evaluation Questionnaire - Appearance scale (PEQ-AP) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.