Evaluation of a Novel Bionic Foot, AMPfoot 4+

Study Overview
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Brief Summary
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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.

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

Conditions
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Prosthesis User, Cognitive Change, Physical Activity

Intervention / Treatment
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* Device: Ankle Mimicking Prosthetic Foot prototype 4+


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral transtibial (below knee) amputee healthy subject K4-level (Medicare), which means highest ambulation level Exclusion Criteria: comorbidities pain in stump

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMPfoot, dual-task, cognitive performance, physical performance, lower-limb prosthesis