Evaluation of a Novel Bionic Foot, AMPfoot 4+

NCT03530956 | Completed

• 1 other identifier: SRP 17
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Keywords

AMPfoot; dual-task; cognitive performance; physical performance; lower-limb prosthesis

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (2)

Current prosthesis

ACTIVE COMPARATOR

A unilateral transtibial amputee will conduct experiments with the current prosthesis

Device: Ankle Mimicking Prosthetic Foot prototype 4+

Novel prosthesis

EXPERIMENTAL

A unilateral transtibial amputee will conduct experiments with the novel prosthesis

Device: Ankle Mimicking Prosthetic Foot prototype 4+

Interventions

Ankle Mimicking Prosthetic Foot prototype 4+ DEVICE

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

Current prosthesis; Novel prosthesis

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• comorbidities
• pain in stump

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

Vrije Universiteit Brussel

Brussels, Vlaams Brabant, 1050, Belgium

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Philosophy

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 21, 2018
• Study Start: October 1, 2016
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: February 11, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)