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

Официальное название

Multidimensional Assessment of a New Ankle-Foot Prosthesis in Daily Use: User Comfort, Safety, and Biomechanical Performance

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство New Articulated Prosthetic Foot
  Participants with a lower-limb amputation will participate in experiments with the prosthetic device
• Устройство Current Prosthetic foot
  Participants with a lower-limb amputation will participate in experiments with the prosthetic device

Первичные конечные точки

• Comparative Scales: Comfort, Safety, Fatigue and Pain [Срок оценки: Through study completion, a period of 3 hours.]
• Preference questionnaire: 5 points Likert scale [Срок оценки: Through study completion, a period of 3 hours.]
• User satisfaction questionnaire: 5 points Likert scale [Срок оценки: Through study completion, a period of 3 hours.]

Вторичные конечные точки (9)

• Hill assessment index [Срок оценки: Through study completion, a period of 3 hours.]
• Stair assessment index [Срок оценки: Through study completion, a period of 3 hours.]
• Ankle Joint angles and angular velocities [Срок оценки: Through study completion, a period of 3 hours.]
• Temporal Gait parameters [Срок оценки: Through study completion, a period of 3 hours.]
• Ankle Joint Moment [Срок оценки: Through study completion, a period of 3 hours.]
• Ankle Joint Power [Срок оценки: Through study completion, a period of 3 hours.]
• Shock absorption [Срок оценки: Through study completion, a period of 3 hours.]
• Multi-axial movement [Срок оценки: Through study completion, a period of 3 hours.]
• Attentional demand [Срок оценки: Through study completion, a period of 3 hours.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Any neurological disease
• Excessive residual limb pain and wounds

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Бельгия · 2 центра

• Vrije Universiteit Brussel — Brussels
• Axiles Bionics — Brussels

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07530601 · CIV-25-10-054755

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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