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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
1
The amputee will walk with AMPfoot 4+, a novel bionic foot, designed and built by an engineer of department MECH (VUB, B)
Vrije Universiteit Brussel
Brussels, Vlaams Brabant, Belgium
Walking distance of a 6 minute walk test
Distance walked during a 6 minute hallway walk test
Time frame: Through study completion, a period of 8 months
Walking speed of a 6 minute walk test
Walking speed during a 6 minute walk test
Time frame: Through study completion, a period of 8 months
Walking speed of a 10 meter walk test
Walking speed during a 10 meter walk test
Time frame: Through study completion, a period of 8 months
Duration of backward counting during walking (dual task)
Duration of the cognitive task backward counting
Time frame: Through study completion, a period of 8 months
Accuracy of backward counting during walking (dual task)
Accuracy of responses of the cognitive task
Time frame: Through study completion, a period of 8 months
Heart rate during walking tasks
Heart rate during 6 minute and 10m walk tests
Time frame: 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.
Time frame: Through study completion, a period of 8 months
Oxygen consumption (VO2) during 6 minute walk test
VO2 during 6 minute walk test
Time frame: 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
Time frame: 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.
Time frame: Through study completion, a period of 8 months
Brain activity
Non-invasive electro-encephalography during walking
Time frame: Through study completion, a period of 8 months
Muscle activity
Non-invasive electro-myography during walking
Time frame: Through study completion, a period of 8 months
Heart activity
Non-invasive electro-cardiography during walking
Time frame: Through study completion, a period of 8 months
Electrodermal activity
Skin sensor during walking determines level of arousal
Time frame: Through study completion, a period of 8 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.