Evaluation of a Novel Bionic Foot, AMPfoot 4+
Prospective Case Study: Adaptation Period of a Novel Motorized Ankle Prosthesis, AMPfoot 4+
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.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Vlaams Brabant
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Brussel, Vlaams Brabant, Belgia, 1050
- Vrije Universiteit Brussel
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- unilateral transtibial (below knee) amputee
- healthy subject
- K4-level (Medicare), which means highest ambulation level
Exclusion Criteria:
- comorbidities
- pain in stump
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Nielosowe
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: Current prosthesis
A unilateral transtibial amputee will conduct experiments with the current prosthesis
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The amputee will walk with AMPfoot 4+, a novel bionic foot, designed and built by an engineer of department MECH (VUB, B)
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Eksperymentalny: Novel prosthesis
A unilateral transtibial amputee will conduct experiments with the novel prosthesis
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The amputee will walk with AMPfoot 4+, a novel bionic foot, designed and built by an engineer of department MECH (VUB, B)
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Walking distance of a 6 minute walk test
Ramy czasowe: Through study completion, a period of 8 months
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Distance walked during a 6 minute hallway walk test
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Through study completion, a period of 8 months
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Walking speed of a 6 minute walk test
Ramy czasowe: Through study completion, a period of 8 months
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Walking speed during a 6 minute walk test
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Through study completion, a period of 8 months
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Walking speed of a 10 meter walk test
Ramy czasowe: Through study completion, a period of 8 months
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Walking speed during a 10 meter walk test
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Through study completion, a period of 8 months
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Duration of backward counting during walking (dual task)
Ramy czasowe: Through study completion, a period of 8 months
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Duration of the cognitive task backward counting
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Through study completion, a period of 8 months
|
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Accuracy of backward counting during walking (dual task)
Ramy czasowe: Through study completion, a period of 8 months
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Accuracy of responses of the cognitive task
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Through study completion, a period of 8 months
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Heart rate during walking tasks
Ramy czasowe: Through study completion, a period of 8 months
|
Heart rate during 6 minute and 10m walk tests
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Through study completion, a period of 8 months
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Rating of Perceived Exertion during walking tasks
Ramy czasowe: Through study completion, a period of 8 months
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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.
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Through study completion, a period of 8 months
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Oxygen consumption (VO2) during 6 minute walk test
Ramy czasowe: Through study completion, a period of 8 months
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VO2 during 6 minute walk test
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Through study completion, a period of 8 months
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Visual analogue scale for fatigue during 6 min walk test
Ramy czasowe: Through study completion, a period of 8 months
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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
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Visual analogue scale for comfort during 6 min walk test
Ramy czasowe: Through study completion, a period of 8 months
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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.
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Through study completion, a period of 8 months
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Brain activity
Ramy czasowe: Through study completion, a period of 8 months
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Non-invasive electro-encephalography during walking
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Through study completion, a period of 8 months
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Muscle activity
Ramy czasowe: Through study completion, a period of 8 months
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Non-invasive electro-myography during walking
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Through study completion, a period of 8 months
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Heart activity
Ramy czasowe: Through study completion, a period of 8 months
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Non-invasive electro-cardiography during walking
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Through study completion, a period of 8 months
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Electrodermal activity
Ramy czasowe: Through study completion, a period of 8 months
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Skin sensor during walking determines level of arousal
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Through study completion, a period of 8 months
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- SRP 17
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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