Evaluation of a Novel Bionic Foot, AMPfoot 4+

NCT ID: NCT03530956

Last Updated: 2019-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2016-12-15

Brief Summary

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.

Conditions

Prosthesis User; Cognitive Change; Physical Activity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Current prosthesis

A unilateral transtibial amputee will conduct experiments with the current prosthesis

Group Type: ACTIVE_COMPARATOR

Ankle Mimicking Prosthetic Foot prototype 4+

Intervention Type: DEVICE

The amputee will walk with AMPfoot 4+, a novel bionic foot, designed and built by an engineer of department MECH (VUB, B)

Novel prosthesis

A unilateral transtibial amputee will conduct experiments with the novel prosthesis

Group Type: EXPERIMENTAL

Ankle Mimicking Prosthetic Foot prototype 4+

Intervention Type: DEVICE

The amputee will walk with AMPfoot 4+, a novel bionic foot, designed and built by an engineer of department MECH (VUB, B)

Interventions

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)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• comorbidities
• pain in stump

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: lead

Responsible Party

Kevin De Pauw

Doctor of Philosophy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vrije Universiteit Brussel

Brussels, Vlaams Brabant, Belgium

Countries

Belgium

Other Identifiers

SRP 17

Identifier Type: -

Identifier Source: org_study_id