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

April 10, 2026 updated by: Vrije Universiteit Brussel

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium, 1050
        • Vrije Universiteit Brussel
        • Contact:
        • Principal Investigator:
          • Kevin De Pauw
      • Brussels, Brussels Capital, Belgium, 1130
        • Axiles Bionics
        • Contact:
        • Sub-Investigator:
          • Fanny Delquignies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New Articulated Prosthetic Foot
Participants will be fitted with the new articulated prosthetic foot and follow the protocol
Device: New Articulated Prosthetic Foot
Participants with a lower-limb amputation will participate in experiments with the prosthetic device
Active Comparator: Current Prosthetic foot
Participants will be fitted with their current prosthetic foot and follow the protocol
Device: Current Prosthetic foot
Participants with a lower-limb amputation will participate in experiments with the prosthetic device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, a period of 3 hours.
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".
Through study completion, a period of 3 hours.
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".
Through study completion, a period of 3 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
Through study completion, a period of 3 hours.
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".
Through study completion, a period of 3 hours.
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.
Through study completion, a period of 3 hours.
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).
Through study completion, a period of 3 hours.
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.
Through study completion, a period of 3 hours.
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.
Through study completion, a period of 3 hours.
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).
Through study completion, a period of 3 hours.
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.
Through study completion, a period of 3 hours.
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).
Through study completion, a period of 3 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vrije Universiteit Brussel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CIV-25-10-054755

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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