Evaluation of a New Articulated Prosthetic Foot: Comfort, Safety and Biomechanics in Individuals With a Lower-Limb Amputation

NCT07530601 | Not Yet Recruiting DMC

• 1 other identifier: CIV-25-10-054755
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical investigation aims to evaluate a new articulated prosthetic foot during daily-life activities.

Conditions

Lower-Limb Amputation

Keywords

ankle-foot prosthesis; daily-life activities

Outcome Measures

Primary Outcomes (3)

• Comparative Scales: Comfort, Safety, Fatigue and Pain

  Visual Analog Scale (VAS) during different activities: walking on flat ground, walking on slopes, climbing and descending stairs, and walking on uneven terrain. VAS is between 0 and 100. Higher scores indicate higher comfort, safety, fatigue or pain.

  Through study completion, a period of 3 hours.

• Preference questionnaire: 5 points Likert scale

  Comparison between the current foot and the new articulated foot in several areas : Mobility \& Functionality, Comfort \& Fit, Stability \& Safety, Mechanical Performance. Likert scale is between 1 and 5, where 1 indicates "Much worse", and 5 indicates "Much better".

  Through study completion, a period of 3 hours.

• User satisfaction questionnaire: 5 points Likert scale

  Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST-device). Satisfaction scale is between 1 and 5, where 1 indicates "Not satisfied at all", and 5 indicates "Very satisfied".

  Through study completion, a period of 3 hours.

Secondary Outcomes (9)

• Hill assessment index

  Through study completion, a period of 3 hours.

• Stair assessment index

  Through study completion, a period of 3 hours.

• Ankle Joint angles and angular velocities

  Through study completion, a period of 3 hours.

• Temporal Gait parameters

  Through study completion, a period of 3 hours.

• Ankle Joint Moment

  Through study completion, a period of 3 hours.

Study Arms (2)

New Articulated Prosthetic Foot

EXPERIMENTAL

Participants will be fitted with the new articulated prosthetic foot and follow the protocol

Device: New Articulated Prosthetic Foot

Current Prosthetic foot

ACTIVE COMPARATOR

Participants will be fitted with their current prosthetic foot and follow the protocol

Device: Current Prosthetic foot

Interventions

Current Prosthetic foot DEVICE

Participants with a lower-limb amputation will participate in experiments with the prosthetic device

Current Prosthetic foot

New Articulated Prosthetic Foot DEVICE

Participants with a lower-limb amputation will participate in experiments with the prosthetic device

New Articulated Prosthetic Foot

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 - 80 years
• Gender: Men and Women
• Level of amputation:
• Unilateral / bilateral
• Transtibial / transfemoral / knee disarticulation / hip disarticulation
• Cause of amputation:
• Vascular, traumatic, cancer and congenital
• Medicare Functional Classification Level: K2-K3-K4
• Completion of post-amputation rehabilitation

You may not qualify if:

• Any neurological disease
• Excessive residual limb pain and wounds

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (2)

Vrije Universiteit Brussel

Brussels, Brussels Capital, 1050, Belgium

Location

Axiles Bionics

Brussels, Brussels Capital, 1130, Belgium

Location

Related Publications (14)

• Agrawal V, Gailey RS, Gaunaurd IA, O'Toole C, Finnieston A, Tolchin R. Comparison of four different categories of prosthetic feet during ramp ambulation in unilateral transtibial amputees. Prosthet Orthot Int. 2015 Oct;39(5):380-9. doi: 10.1177/0309364614536762. Epub 2014 Jun 12.

  PMID: 24925671 BACKGROUND

• General Assembly of the World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent. 2014 Summer;81(3):14-8.

  PMID: 25951678 BACKGROUND

• Shepherd MK, Simon AM, Zisk J, Hargrove LJ. Patient-Preferred Prosthetic Ankle-Foot Alignment for Ramps and Level-Ground Walking. IEEE Trans Neural Syst Rehabil Eng. 2021;29:52-59. doi: 10.1109/TNSRE.2020.3033711. Epub 2021 Feb 25.

  PMID: 33104504 BACKGROUND

• Schmalz T, Blumentritt S, Marx B. Biomechanical analysis of stair ambulation in lower limb amputees. Gait Posture. 2007 Feb;25(2):267-78. doi: 10.1016/j.gaitpost.2006.04.008. Epub 2006 May 24.

  PMID: 16725325 BACKGROUND

• Omana H, Madou E, Montero-Odasso M, Payne MW, Viana R, Hunter SW. The effect of dual-task testing on the balance and gait of people with lower limb amputations: A systematic review. PM R. 2023 Jan;15(1):94-128. doi: 10.1002/pmrj.12702. Epub 2021 Nov 13.

  PMID: 34464018 BACKGROUND

• Maciejasz P, Budny T, Sauer M, Umari M, Korber J, Ernst J, Altenburg B, Hahn A, Braatz F. User preference and patient benefits of a novel energy storing and return foot: A randomized, cross-over clinical trial. Prosthet Orthot Int. 2025 Dec 1;49(6):645-653. doi: 10.1097/PXR.0000000000000415. Epub 2024 Dec 4.

  PMID: 39630588 BACKGROUND

• Legro MW, Reiber GD, Smith DG, del Aguila M, Larsen J, Boone D. Prosthesis evaluation questionnaire for persons with lower limb amputations: assessing prosthesis-related quality of life. Arch Phys Med Rehabil. 1998 Aug;79(8):931-8. doi: 10.1016/s0003-9993(98)90090-9.

  PMID: 9710165 BACKGROUND

• Lathouwers E, Ampe T, Diaz MA, Meeusen R, De Pauw K. Evaluation of an articulated passive ankle-foot prosthesis. Biomed Eng Online. 2022 Apr 27;21(1):28. doi: 10.1186/s12938-022-00997-6.

  PMID: 35477464 BACKGROUND

• Jonkergouw N, Prins MR, Buis AW, van der Wurff P. The Effect of Alignment Changes on Unilateral Transtibial Amputee's Gait: A Systematic Review. PLoS One. 2016 Dec 6;11(12):e0167466. doi: 10.1371/journal.pone.0167466. eCollection 2016.

  PMID: 27923050 BACKGROUND

• Hunter SW, Frengopoulos C, Holmes J, Viana R, Payne MW. Determining Reliability of a Dual-Task Functional Mobility Protocol for Individuals With Lower Extremity Amputation. Arch Phys Med Rehabil. 2018 Apr;99(4):707-712. doi: 10.1016/j.apmr.2017.12.008. Epub 2018 Jan 6.

  PMID: 29317224 BACKGROUND

• Highsmith MJ, Kahle JT, Kaluf B, Miro RM, Mengelkoch LJ, Klenow TD. PSYCHOMETRIC EVALUATION OF THE HILL ASSESSMENT INDEX (HAI) AND STAIR ASSESSMENT INDEX (SAI) IN HIGH-FUNCTIONING TRANSFEMORAL AMPUTEES. Technol Innov. 2016 Sep;18(2-3):193-201. doi: 10.21300/18.2-3.2016.193.

  PMID: 28066528 BACKGROUND

• Hahn A, Sreckovic I, Reiter S, Mileusnic M. First results concerning the safety, walking, and satisfaction with an innovative, microprocessor-controlled four-axes prosthetic foot. Prosthet Orthot Int. 2018 Jun;42(3):350-356. doi: 10.1177/0309364617747976. Epub 2018 Feb 5.

  PMID: 29400252 BACKGROUND

• Demers, L., Weiss-Lambrou, R., & Ska, B. (2002). The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0): an overview and recent progress. Technology and disability, 14(3), 101-105.

  BACKGROUND

• Bai X, Ewins D, Crocombe AD, Xu W. Kinematic and biomimetic assessment of a hydraulic ankle/foot in level ground and camber walking. PLoS One. 2017 Jul 13;12(7):e0180836. doi: 10.1371/journal.pone.0180836. eCollection 2017.

  PMID: 28704428 BACKGROUND

Central Study Contacts

Kevin De Pauw

CONTACT

475 67 82 64; kevin.de.pauw@vub.be

Study Design

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

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: April 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)