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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Vlaams Brabant
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Brussel, Vlaams Brabant, Bélgica, 1050
- Vrije Universiteit Brussel
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- unilateral transtibial (below knee) amputee
- healthy subject
- K4-level (Medicare), which means highest ambulation level
Exclusion Criteria:
- comorbidities
- pain in stump
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Walking distance of a 6 minute walk test
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Through study completion, a period of 8 months
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
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Through study completion, a period of 8 months
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Visual analogue scale for comfort during 6 min walk test
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- SRP 17
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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