Clinical trial NCT03530956: Evaluation of a Novel Bionic Foot, AMPfoot 4+
Official title: Prospective Case Study: Adaptation Period of a Novel Motorized Ankle Prosthesis, AMPfoot 4+
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthesis User
Cognitive Change
Physical Activity
Keywords: AMPfoot
dual-task
cognitive performance
physical performance
lower-limb prosthesis
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 1
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* comorbidities
* pain in stump

Primary outcomes:
measure: Walking distance of a 6 minute walk test
timeFrame: Through study completion, a period of 8 months
measure: Walking speed of a 6 minute walk test
timeFrame: Through study completion, a period of 8 months
measure: Walking speed of a 10 meter walk test
timeFrame: Through study completion, a period of 8 months
measure: Duration of backward counting during walking (dual task)
timeFrame: Through study completion, a period of 8 months
measure: Accuracy of backward counting during walking (dual task)
timeFrame: Through study completion, a period of 8 months
measure: Heart rate during walking tasks
timeFrame: Through study completion, a period of 8 months
measure: Rating of Perceived Exertion during walking tasks
timeFrame: Through study completion, a period of 8 months
measure: Oxygen consumption (VO2) during 6 minute walk test
timeFrame: Through study completion, a period of 8 months
measure: Visual analogue scale for fatigue during 6 min walk test
timeFrame: Through study completion, a period of 8 months
measure: Visual analogue scale for comfort during 6 min walk test
timeFrame: Through study completion, a period of 8 months
measure: Brain activity
timeFrame: Through study completion, a period of 8 months
measure: Muscle activity
timeFrame: Through study completion, a period of 8 months
measure: Heart activity
timeFrame: Through study completion, a period of 8 months
measure: Electrodermal activity
timeFrame: Through study completion, a period of 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Vrije Universiteit Brussel
state: Vlaams Brabant
Study officials:
References: