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NCT Number: NCT07530601

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

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

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Key information

Conditions

Lower-Limb Amputation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Axiles Bionics, Brussels, Brussels Capital, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

New Articulated Prosthetic Foot

Device

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

Current Prosthetic foot

Device

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

Primary outcomes

  1. Comparative Scales: Comfort, Safety, Fatigue and Pain

    Time frame: Through study completion, a period of 3 hours.

    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.

  2. Preference questionnaire: 5 points Likert scale

    Time frame: Through study completion, a period of 3 hours.

    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".

  3. User satisfaction questionnaire: 5 points Likert scale

    Time frame: Through study completion, a period of 3 hours.

    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".

Secondary outcomes

  1. Hill assessment index

    Time frame: Through study completion, a period of 3 hours.

    Walking on slopes. Hill assessment index is between 0 and 11, where 0 indicates "Cannot do" and 11 indicates "Even steps without assistive device"

  2. Stair assessment index

    Time frame: Through study completion, a period of 3 hours.

    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".

  3. Ankle Joint angles and angular velocities

    Time frame: Through study completion, a period of 3 hours.

    Measured through onboard sensors (ankle encoder), in degrees and degrees/second.

  4. Temporal Gait parameters

    Time frame: Through study completion, a period of 3 hours.

    Step time, stance and swing time, measured in seconds through on-board sensors (IMUs).

  5. Ankle Joint Moment

    Time frame: Through study completion, a period of 3 hours.

    Measured through on-board sensors (force sensor and ankle encoder) expressed in Newton*meter.

  6. Ankle Joint Power

    Time frame: Through study completion, a period of 3 hours.

    Measured through on-board sensors (force sensor and ankle encoder) expressed in Watt.

  7. Shock absorption

    Time frame: Through study completion, a period of 3 hours.

    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).

  8. Multi-axial movement

    Time frame: Through study completion, a period of 3 hours.

    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.

  9. Attentional demand

    Time frame: Through study completion, a period of 3 hours.

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin De Pauw

CONTACT

[email protected]

475 67 82 64 ext. +32

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study title

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

Acronym: MAP-CSB

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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