Prospective Case Study: Adaptation Period of a Novel Motorized Ankle Prosthesis, AMPfoot 4+
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Walking speed of a 10 meter walk test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •unilateral transtibial (below knee) amputee
- •healthy subject
- •K4-level (Medicare), which means highest ambulation level
排除标准
- •comorbidities
- •pain in stump
结局指标
主要结局
Walking speed of a 10 meter walk test
时间窗: Through study completion, a period of 8 months
Walking speed during a 10 meter walk test
Duration of backward counting during walking (dual task)
时间窗: Through study completion, a period of 8 months
Duration of the cognitive task backward counting
Electrodermal activity
时间窗: Through study completion, a period of 8 months
Skin sensor during walking determines level of arousal
Accuracy of backward counting during walking (dual task)
时间窗: Through study completion, a period of 8 months
Accuracy of responses of the cognitive task
Rating of Perceived Exertion during walking tasks
时间窗: Through study completion, a period of 8 months
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.
Visual analogue scale for fatigue during 6 min walk test
时间窗: Through study completion, a period of 8 months
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
Brain activity
时间窗: Through study completion, a period of 8 months
Non-invasive electro-encephalography during walking
Heart rate during walking tasks
时间窗: Through study completion, a period of 8 months
Heart rate during 6 minute and 10m walk tests
Muscle activity
时间窗: Through study completion, a period of 8 months
Non-invasive electro-myography during walking
Walking speed of a 6 minute walk test
时间窗: Through study completion, a period of 8 months
Walking speed during a 6 minute walk test
Visual analogue scale for comfort during 6 min walk test
时间窗: Through study completion, a period of 8 months
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.
Walking distance of a 6 minute walk test
时间窗: Through study completion, a period of 8 months
Distance walked during a 6 minute hallway walk test
Oxygen consumption (VO2) during 6 minute walk test
时间窗: Through study completion, a period of 8 months
VO2 during 6 minute walk test
Heart activity
时间窗: Through study completion, a period of 8 months
Non-invasive electro-cardiography during walking
次要结局
未报告次要终点
研究者
Kevin De Pauw
Doctor of Philosophy
Vrije Universiteit Brussel