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This clinical investigation aims to evaluate a new articulated prosthetic foot during daily-life activities.
This clinical investigation aims to evaluate a new articulated prosthetic foot during daily-life activities.
The primary objective of this clinical investigation is to evaluate the safety, effectiveness, and comfort of the new prosthetic foot, along with user satisfaction and its impact on quality of life during daily-life activities. The study aims to determine whether the prosthetic foot can be safely and effectively integrated into the users' routine mobility, while also providing a comfortable experience that enhances overall well-being. In addition to these primary outcomes, the study will address several secondary objectives to gain a more comprehensive understanding of the device's performance. These include assessing the biomechanical characteristics of walking with the new prosthetic foot, specifically focusing on gait parameters. The investigation also aims to evaluate the device's shock absorption capabilities and its ability to support multi-axial movement, both of which are important for natural and efficient locomotion. Furthermore, the study will explore the attentional demand required when walking with the new prosthetic foot, providing insight into how the device affects mental engagement during ambulation. Lastly, the influence of prosthetic alignment on performance and user experience will be examined to optimize fitting and functionality.
Overall, the new prosthetic foot will be assessed during a variety of daily-life activities, with varying familiarization periods, allowing for a holistic evaluation of the prosthetic foot in realistic and diverse usage conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Articulated Prosthetic Foot | Experimental | Participants will be fitted with the new articulated prosthetic foot and follow the protocol |
|
| Current Prosthetic foot | Active Comparator | Participants will be fitted with their current prosthetic foot and follow the protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Articulated Prosthetic Foot | Device | Participants with a lower-limb amputation will participate in experiments with the prosthetic device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hill assessment index | Walking on slopes. Hill assessment index is between 0 and 11, where 0 indicates "Cannot do" and 11 indicates "Even steps without assistive device" | Through study completion, a period of 3 hours. |
| Stair assessment index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin De Pauw | Contact | 475 67 82 64 | +32 | kevin.de.pauw@vub.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vrije Universiteit Brussel | Brussels | Brussels Capital | 1050 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24925671 | Background | 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. | |
| 25951678 | 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. |
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| Current Prosthetic foot | Device | Participants with a lower-limb amputation will participate in experiments with the prosthetic device |
|
Climbing and descending stairs. Index goes from 0 to 13, where 0 means "Cannot do" and 13 means "Without rail and assistive device, step over step pattern".
| Through study completion, a period of 3 hours. |
| Ankle Joint angles and angular velocities | Measured through onboard sensors (ankle encoder), in degrees and degrees/second. | Through study completion, a period of 3 hours. |
| Temporal Gait parameters | Step time, stance and swing time, measured in seconds through on-board sensors (IMUs). | Through study completion, a period of 3 hours. |
| Ankle Joint Moment | Measured through on-board sensors (force sensor and ankle encoder) expressed in Newton*meter. | Through study completion, a period of 3 hours. |
| Ankle Joint Power | Measured through on-board sensors (force sensor and ankle encoder) expressed in Watt. | Through study completion, a period of 3 hours. |
| Shock absorption | Measure of the shock absorption using data from Inertial Measurement Units (IMU) sensors. The measurement is expressed as a continuous value in multiples of g (g = gravitational force). | Through study completion, a period of 3 hours. |
| Multi-axial movement | Movement of the prosthetic ankle in the sagittal, coronal and transverse plane, measured in degrees with respect to its rest position. Measured via on-board Inertial Measurement Units (IMU) and ankle encoder. | Through study completion, a period of 3 hours. |
| Attentional demand | Dual-task L-test: functional mobility assessment measuring the time taken to walk 20 meters in an L-shaped path, while simultaneously performing a cognitive task (e.g. subtractions). | Through study completion, a period of 3 hours. |
| Axiles Bionics | Brussels | Brussels Capital | 1130 | Belgium |
|
| 33104504 | 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. |
| 16725325 | 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. |
| 34464018 | 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. |
| 39630588 | 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. |
| 9710165 | 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. |
| 35477464 | 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. |
| 27923050 | 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. |
| 29317224 | 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. |
| 28066528 | 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. |
| 29400252 | 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. |
| 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. |
| 28704428 | 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. |