A Comprehensive Evaluation of a the Talaris Demonstrator (TD)

A Comprehensive Evaluation of a New Generation Bionic Foot

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.

Study Overview

• Status: Unknown
• Conditions: Amputation
• Intervention / Treatment: Device: Talaris Demonstrator

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Biomechanical; All experimental tasks will be evaluated on biomechanical outcome measures	Device: Talaris Demonstrator; The Talaris Demonstrator will be evaluated during daily activities and compared to the current prosthesis
Other: Psychological; All experimental tasks will be evaluated on psychological outcome measures	Device: Talaris Demonstrator; The Talaris Demonstrator will be evaluated during daily activities and compared to the current prosthesis
Other: Physiological; All experimental tasks will be evaluated on biomechanical outcome measures	Device: Talaris Demonstrator; The Talaris Demonstrator will be evaluated during daily activities and compared to the current prosthesis
Other: Performance; All experimental tasks will be evaluated on biomechanical outcome measures	Device: Talaris Demonstrator; The Talaris Demonstrator will be evaluated during daily activities and compared to the current prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomechanical: step length	Step Length in cm	1 year
Biomechanical: cadence	Cadence steps/min	1 year
Biomechanical: step width	Step width in cm	1 year
Biomechanical: swing phases	in % of gait cycle	1 year
Biomechanical: stance phases	in % of gait cycle	1 year
Physiological: oxygen consumption	in ml/min/kg	1 year
Psychological: Visual Analogue Scale	For Fatigue and Comfort on a scale from 0 to 10	1 year
Performance: walking speed	In meter per second	1 year
Performance: duration	secondfs	1 year

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: VUB-Axiles

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
• product manufactured in and exported from the U.S.: No