This clinical investigation aims to evaluate a new articulated prosthetic foot during daily-life activities.
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
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
120
Participants with a lower-limb amputation will participate in experiments with the prosthetic device
Participants with a lower-limb amputation will participate in experiments with the prosthetic device
Vrije Universiteit Brussel
Brussels, Brussels Capital, Belgium
Axiles Bionics
Brussels, Brussels Capital, Belgium
Comparative Scales: Comfort, Safety, Fatigue and Pain
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.
Time frame: Through study completion, a period of 3 hours.
Preference questionnaire: 5 points Likert scale
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".
Time frame: Through study completion, a period of 3 hours.
User satisfaction questionnaire: 5 points Likert scale
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".
Time frame: Through study completion, a period of 3 hours.
Hill assessment index
Walking on slopes. Hill assessment index is between 0 and 11, where 0 indicates "Cannot do" and 11 indicates "Even steps without assistive device"
Time frame: Through study completion, a period of 3 hours.
Stair assessment index
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".
Time frame: Through study completion, a period of 3 hours.
Ankle Joint angles and angular velocities
Measured through onboard sensors (ankle encoder), in degrees and degrees/second.
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Time frame: Through study completion, a period of 3 hours.
Temporal Gait parameters
Step time, stance and swing time, measured in seconds through on-board sensors (IMUs).
Time frame: Through study completion, a period of 3 hours.
Ankle Joint Moment
Measured through on-board sensors (force sensor and ankle encoder) expressed in Newton\*meter.
Time frame: Through study completion, a period of 3 hours.
Ankle Joint Power
Measured through on-board sensors (force sensor and ankle encoder) expressed in Watt.
Time frame: Through study completion, a period of 3 hours.
Shock absorption
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).
Time frame: Through study completion, a period of 3 hours.
Multi-axial movement
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.
Time frame: Through study completion, a period of 3 hours.
Attentional demand
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).
Time frame: Through study completion, a period of 3 hours.