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

Vrije Universiteit Brussel

Status: Not yet enrolling

Conditions: Lower-Limb Amputation

Treatments: Device: Current Prosthetic foot; Device: New Articulated Prosthetic Foot

Study type: Interventional

Funder types: Other

Identifiers

NCT07530601

CIV-25-10-054755

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

New Articulated Prosthetic Foot

Experimental group

Description:

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

Treatment:

Device: New Articulated Prosthetic Foot

Current Prosthetic foot

Active Comparator group

Description:

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

Treatment:

Device: Current Prosthetic foot