Study on a Prosthetic Foot With Adjustable Heel Height

NCT07214493 | Recruiting

• 1 other identifier: BP-11-PT009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Lower Limb Amputation Above Knee; Lower Limb Amputation Below Knee

Keywords

Lower limb amputation; Prosthetic foot; Adjustable heel height; Hydraulic ankle

Outcome Measures

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.

  30 days

Secondary Outcomes (7)

• Patient Specific functional Scale (PSFS)

  30 days

• Psychosocial Impact of Assistive Device Scale (PIADS)

  30 days

• Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)

  30 days

• Visual Analog Scale (VAS) for the adequacy to life's project

  30 days

• EuroQuol - 5 Dimensions - 5 Levels (EQ-5D-5L)

  30 days

Study Arms (2)

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.

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

Device: Taleo Adjust; Device: The usual participant's foot

Interventions

Taleo Adjust DEVICE

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.

Taleo Adjust foot then usual foot; Usual foot then taleo Adjust foot

The usual participant's foot DEVICE

The usual foot of the participant is an Energy Storage and Return (ESR) prosthetic foot (no heel height adjustement)

Taleo Adjust foot then usual foot; Usual foot then taleo Adjust foot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otto Bock France SNC: lead

Study Sites (5)

CH Cornouaille

Concarneau, France

RECRUITING

CHU Grenoble

Échirolles, France

RECRUITING

IRR Louis Pierquin

Nancy, France

RECRUITING

CRRF La Tourmaline

Saint-Herblain, France

RECRUITING

Institut Merle d'Aubigné

Valenton, France

RECRUITING

Study Officials

• Brice LAVRARD, Dr.

  Institut Merle d'Aubigné - VALENTON

  STUDY CHAIR

• Isabelle LOIRET

  IRR Louis Pierquin - NANCY

  STUDY CHAIR

Central Study Contacts

Aurelie LACROIX

CONTACT

0033 (0)7 86 29 52 03; aurelie.lacroix@ottobock.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 9, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): June 6, 2026
• Study Completion (Estimated): June 6, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)