Ignite Creation Date:
2024-05-06 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03530956
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2018-04-25
Brief Title:
Evaluation of a Novel Bionic Foot AMPfoot 4
Sponsor:
Vrije Universiteit Brussel
Organization:
Vrije Universiteit Brussel
Study Overview
Official Title:
Prospective Case Study Adaptation Period of a Novel Motorized Ankle Prosthesis AMPfoot 4
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie the 6-minute walk test 6MWT and the 10-meter walk test The 6MWT will be combined with a cognitive task ie 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 conductanceaccuracy 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
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 ie the 6-minute walk test 6MWT and the 10-meter walk test The 6MWT will be combined with a cognitive task ie 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 conductanceaccuracy 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None