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ClinicalTrials.gov ID

NCT07530601

Lead Sponsor

Vrije Universiteit BrusselOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

120Estimated

Last Update Posted

Apr 15, 2026Actual

Start Date

Apr 2026Estimated

Primary Completion Date

Apr 2027Estimated

Completion Date

Jun 2027Estimated

Official Title

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

Brief Summary

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

Detailed Description

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.

• Lower-Limb Amputation

• New Articulated Prosthetic Foot
• Current Prosthetic foot

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Any neurological disease
• Excessive residual limb pain and wounds

Primary Purpose

Basic Science

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

None (Open Label)

Lead Sponsor

Vrije Universiteit BrusselOTHER

fanny@axilesbionics.com6 70 69 94 23 ext. +33