Lower-Limb Amputation
Conditions
Keywords
ankle-foot prosthesis, daily-life activities
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.
Interventions
DEVICENew Articulated Prosthetic Foot
Participants with a lower-limb amputation will participate in experiments with the prosthetic device
DEVICECurrent Prosthetic foot
Participants with a lower-limb amputation will participate in experiments with the prosthetic device
Sponsors
Vrije Universiteit Brussel
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparative Scales: Comfort, Safety, Fatigue and Pain | 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. |
| Preference questionnaire: 5 points Likert scale | 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". |
| User satisfaction questionnaire: 5 points Likert scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Hill assessment index | 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" |
| Stair assessment index | 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". |
| Ankle Joint angles and angular velocities | Through study completion, a period of 3 hours. | Measured through onboard sensors (ankle encoder), in degrees and degrees/second. |
| Temporal Gait parameters | Through study completion, a period of 3 hours. | Step time, stance and swing time, measured in seconds through on-board sensors (IMUs). |
| Ankle Joint Moment | Through study completion, a period of 3 hours. | Measured through on-board sensors (force sensor and ankle encoder) expressed in Newton\*meter. |
| Ankle Joint Power | Through study completion, a period of 3 hours. | Measured through on-board sensors (force sensor and ankle encoder) expressed in Watt. |
| Shock absorption | 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). |
| Multi-axial movement | 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. |
| Attentional demand | 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). |
Countries
Belgium
Contacts
CONTACTKevin De Pauw
Outcome results
None listed