Evaluation of a Novel Bionic Foot, AMPfoot 4+

Not Applicable

Completed

• Conditions: Prosthesis User; Physical Activity; Cognitive Change
• Interventions: Device: Ankle Mimicking Prosthetic Foot prototype 4+

• Registration Number: NCT03530956
• Lead Sponsor: Vrije Universiteit Brussel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Primary Completion: 2016-12-15
• Study Completion: 2016-12-15
• Study First Submitted: 2018-04-25
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-21
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

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

Exclusion Criteria

• comorbidities
• pain in stump

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Novel prosthesis	Ankle Mimicking Prosthetic Foot prototype 4+	A unilateral transtibial amputee will conduct experiments with the novel prosthesis
Current prosthesis	Ankle Mimicking Prosthetic Foot prototype 4+	A unilateral transtibial amputee will conduct experiments with the current prosthesis

Primary Outcome Measures

Name	Time	Method
Visual analogue scale for comfort during 6 min walk test	Through study completion, a period of 8 months	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.
Walking speed of a 10 meter walk test	Through study completion, a period of 8 months	Walking speed during a 10 meter walk test
Duration of backward counting during walking (dual task)	Through study completion, a period of 8 months	Duration of the cognitive task backward counting
Electrodermal activity	Through study completion, a period of 8 months	Skin sensor during walking determines level of arousal
Accuracy of backward counting during walking (dual task)	Through study completion, a period of 8 months	Accuracy of responses of the cognitive task
Rating of Perceived Exertion during walking tasks	Through study completion, a period of 8 months	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.
Visual analogue scale for fatigue during 6 min walk test	Through study completion, a period of 8 months	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
Brain activity	Through study completion, a period of 8 months	Non-invasive electro-encephalography during walking
Heart rate during walking tasks	Through study completion, a period of 8 months	Heart rate during 6 minute and 10m walk tests
Muscle activity	Through study completion, a period of 8 months	Non-invasive electro-myography during walking
Walking speed of a 6 minute walk test	Through study completion, a period of 8 months	Walking speed during a 6 minute walk test
Walking distance of a 6 minute walk test	Through study completion, a period of 8 months	Distance walked during a 6 minute hallway walk test
Oxygen consumption (VO2) during 6 minute walk test	Through study completion, a period of 8 months	VO2 during 6 minute walk test
Heart activity	Through study completion, a period of 8 months	Non-invasive electro-cardiography during walking

Trial Locations

Locations (1)

Vrije Universiteit Brussel; 🇧🇪 Brussel, Vlaams Brabant, Belgium