Clinical trial NCT04599530: A Comprehensive Evaluation of a the Talaris Demonstrator
Official title: A Comprehensive Evaluation of a New Generation Bionic Foot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amputation
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A within Subject Design
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The Talaris Demonstrator is developed in continuation of previous prototypes called the AMPfoot 2.0, 3.0 and 4.0. The main goal of the experiment is to evaluate the effectiveness of TD during daily activities.

Detailed description: A within study design will be conducted in order to evaluate four different prosthetic devices (current, non-propulsive TDF, propulsive TDF and Cyberlegs) with ten participants.

Prior to the baseline test, a familiarization trial aimed to accustom participants to the experimental protocol, to get used to the measurements and interface of the measurement devices. The baseline experimental trial is implemented to evaluate the current prosthesis during the different tests. The same tests will be performed during the evaluation of the other devices. Participants are asked to perform the following consecutive tasks with ten minutes of rest in between each task. The first task is a stair climbing test where participants' will be asked to ascend and descend a staircase. Participants start in front of the staircase and are asked to ascend and descend as fast as possible. Bilateral handrails are required to allow support when needed. The ascending phase is initiated with the prosthetic side, while the first step of the descending phase is performed with the non-involved leg. The second task is the L-test, where participants are asked to rise from a chair, walk through an office door, turn 90 degrees, walk down a hallway, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter will be covered. The slope walking test assesses the participants' ability to ascend and descend an inclined ramp as fast as possible. For safety reasons bilateral handrails are warranted. Participants start the test in an upright position in front of the ramp and are asked to ascend the ramp, turn around on the platform, descend the ramp and return to the starting position. During a two-minute walk test, participants are asked to respond as fast as possible to a stimulus visualized on a computer screen one meter in front of the treadmill. Finally, a hallway six-minute walk test will be performed on a hallway at a self-selected walking speed, which closely relates to the most efficient walking speed.

In between each test with a novel device, participants need accustom to the novel device to ensure a good alignment and fitting. Participants will be fitted and aligned to the novel device by a physiotherapist and prosthetist.

Eligibility criteria: Inclusion Criteria:

* Age: 25 - 75 years
* Gender: men and women
* Level of amputation: unilateral transfemoral
* Vascular, traumatic, congenital or other cause of amputation
* Completed the rehabilitation program, meaning that participants possess their final prosthesis
* Medicare Functional Classification Level: K2-4
* Participants wear their prosthesis for at least 8 hours/day

Exclusion Criteria:

* Any neurological disease
* No upper limb or bilateral amputation
* Stump pain or bad fit of the socket

Primary outcomes:
measure: Biomechanical: step length
timeFrame: 1 year
measure: Biomechanical: cadence
timeFrame: 1 year
measure: Biomechanical: step width
timeFrame: 1 year
measure: Biomechanical: swing phases
timeFrame: 1 year
measure: Biomechanical: stance phases
timeFrame: 1 year
measure: Physiological: oxygen consumption
timeFrame: 1 year
measure: Psychological: Visual Analogue Scale
timeFrame: 1 year
measure: Performance: walking speed
timeFrame: 1 year
measure: Performance: duration
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: