Evaluation of a Novel Bionic Foot, AMPfoot 4+

Physical Activity Clinical Trial

Official title:

Prospective Case Study: Adaptation Period of a Novel Motorized Ankle Prosthesis, AMPfoot 4+

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530956
• Other study ID #: SRP 17
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: December 15, 2016

Study information

• Verified date: February 2019
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 15, 2016
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

Inclusion Criteria:

• unilateral transtibial (below knee) amputee

• healthy subject

• K4-level (Medicare), which means highest ambulation level

Exclusion Criteria:

• comorbidities

• pain in stump

Related Conditions & MeSH terms

• Cognitive Change
• Physical Activity
• Prosthesis User

Intervention

Device:
• Ankle Mimicking Prosthetic Foot prototype 4+
The amputee will walk with AMPfoot 4+, a novel bionic foot, designed and built by an engineer of department MECH (VUB, B)

Locations

Country	Name	City	State
Belgium	Vrije Universiteit Brussel	Brussel	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking distance of a 6 minute walk test	Distance walked during a 6 minute hallway walk test	Through study completion, a period of 8 months
Primary	Walking speed of a 6 minute walk test	Walking speed during a 6 minute walk test	Through study completion, a period of 8 months
Primary	Walking speed of a 10 meter walk test	Walking speed during a 10 meter walk test	Through study completion, a period of 8 months
Primary	Duration of backward counting during walking (dual task)	Duration of the cognitive task backward counting	Through study completion, a period of 8 months
Primary	Accuracy of backward counting during walking (dual task)	Accuracy of responses of the cognitive task	Through study completion, a period of 8 months
Primary	Heart rate during walking tasks	Heart rate during 6 minute and 10m walk tests	Through study completion, a period of 8 months
Primary	Rating of Perceived Exertion during walking tasks	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.	Through study completion, a period of 8 months
Primary	Oxygen consumption (VO2) during 6 minute walk test	VO2 during 6 minute walk test	Through study completion, a period of 8 months
Primary	Visual analogue scale for fatigue during 6 min walk test	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
Primary	Visual analogue scale for comfort during 6 min walk test	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.	Through study completion, a period of 8 months
Primary	Brain activity	Non-invasive electro-encephalography during walking	Through study completion, a period of 8 months
Primary	Muscle activity	Non-invasive electro-myography during walking	Through study completion, a period of 8 months
Primary	Heart activity	Non-invasive electro-cardiography during walking	Through study completion, a period of 8 months
Primary	Electrodermal activity	Skin sensor during walking determines level of arousal	Through study completion, a period of 8 months