Evaluation of a Novel Bionic Foot, AMPfoot 4+

Prospective Case Study: Adaptation Period of a Novel Motorized Ankle Prosthesis, AMPfoot 4+

Background: Evaluating the use of a novel motorized ankle prosthesis during walking and under dual task circumstances is an important step in product development.

Objective: To iteratively evaluate the effectiveness of a novel bionic foot, the Ankle Mimicking Prosthetic device 4+ (or AMPfoot 4+), during walking.

Study design: Case study (crossover) research design.

Methods: One male subject will conduct a baseline experimental trial with the current prosthetic device and several experimental trials with the AMPfoot 4+ to evaluate the effectiveness of the novel device and investigate the adaptation period. Prior to baseline experiments, a familiarization trial will be performed to determine intra-subject variability of the dual task. An experimental trial consists of 2 walking tasks, i.e. the 6-minute walk test (6MWT) and the 10-meter walk test. The 6MWT will be combined with a cognitive task, i.e. backwards counting, to create dual task circumstances. The outcome measurements for the dual task are the distance covered and the walking speed, heart rate (HR) (Polar), rating of perceived exertion (RPE), VO2 (Cosmed K5), electro-encephalography (EEG), electro-myography (EMG), electro-cardiography (ECG), electrodermal activity (/skin conductance),accuracy and total duration of the cognitive task, BodyMedia (physical activity) and the visual analogue scale (VAS) for fatigue and comfort. A 10-meter walk test will be evaluated on duration.

Expected findings: In a first phase the novel device will probably reduce walking and cognitive performance, whereas fine-tuning the mechatronics (after several retests) should improve walking and cognitive performance during walking.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Cognitive Change; Prosthesis User
• Intervention / Treatment: Device: Ankle Mimicking Prosthetic Foot prototype 4+

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams Brabant
    • Brussel, Vlaams Brabant, Belgium, 1050
      • Vrije Universiteit Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• unilateral transtibial (below knee) amputee
• healthy subject
• K4-level (Medicare), which means highest ambulation level

Exclusion Criteria:

• comorbidities
• pain in stump

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Current prosthesis; A unilateral transtibial amputee will conduct experiments with the current prosthesis	Device: Ankle Mimicking Prosthetic Foot prototype 4+; The amputee will walk with AMPfoot 4+, a novel bionic foot, designed and built by an engineer of department MECH (VUB, B)
Experimental: Novel prosthesis; A unilateral transtibial amputee will conduct experiments with the novel prosthesis	Device: Ankle Mimicking Prosthetic Foot prototype 4+; The amputee will walk with AMPfoot 4+, a novel bionic foot, designed and built by an engineer of department MECH (VUB, B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking distance of a 6 minute walk test	Distance walked during a 6 minute hallway walk test	Through study completion, a period of 8 months
Walking speed of a 6 minute walk test	Walking speed during a 6 minute walk test	Through study completion, a period of 8 months
Walking speed of a 10 meter walk test	Walking speed during a 10 meter walk test	Through study completion, a period of 8 months
Duration of backward counting during walking (dual task)	Duration of the cognitive task backward counting	Through study completion, a period of 8 months
Accuracy of backward counting during walking (dual task)	Accuracy of responses of the cognitive task	Through study completion, a period of 8 months
Heart rate during walking tasks	Heart rate during 6 minute and 10m walk tests	Through study completion, a period of 8 months
Rating of Perceived Exertion during walking tasks	Rating of Perceived Exertion ranges from 6 (no exertion) until 20 (maximal exertion) during 6 minute and 10m walk tests. Higher values indicate a higher subjective feeling of exertion.	Through study completion, a period of 8 months
Oxygen consumption (VO2) during 6 minute walk test	VO2 during 6 minute walk test	Through study completion, a period of 8 months
Visual analogue scale for fatigue during 6 min walk test	Value at a scale (from 1 to 10) is provided using an X (as sign) and determines level of fatigue during walking. The higher the value the higher the level of fatigue	Through study completion, a period of 8 months
Visual analogue scale for comfort during 6 min walk test	Value at a scale (from 1 to 10) is provided using an X (as sign) and determines level of comfort during walking. The higher the value the higher the level of comfort.	Through study completion, a period of 8 months
Brain activity	Non-invasive electro-encephalography during walking	Through study completion, a period of 8 months
Muscle activity	Non-invasive electro-myography during walking	Through study completion, a period of 8 months
Heart activity	Non-invasive electro-cardiography during walking	Through study completion, a period of 8 months
Electrodermal activity	Skin sensor during walking determines level of arousal	Through study completion, a period of 8 months

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): December 15, 2016
• Study Completion (Actual): December 15, 2016

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: physical performance; dual-task; cognitive performance; AMPfoot; lower-limb prosthesis
• Other Study ID Numbers: SRP 17

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