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Completed

NCT Number: NCT03530956

Evaluation of a Novel Bionic Foot, 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.

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Key information

Conditions

Prosthesis User Behavior Cognitive Change Motor Activity Physical Activity

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vrije Universiteit Brussel

Brussels, Vlaams Brabant, 1050, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • comorbidities
  • pain in stump

Treatment and study plan

Ankle Mimicking Prosthetic Foot prototype 4+

Device

The amputee will walk with AMPfoot 4+, a novel bionic foot, designed and built by an engineer of department MECH (VUB, B)

Primary outcomes

  1. Walking distance of a 6 minute walk test

    Time frame: Through study completion, a period of 8 months

    Distance walked during a 6 minute hallway walk test

  2. Walking speed of a 6 minute walk test

    Time frame: Through study completion, a period of 8 months

    Walking speed during a 6 minute walk test

  3. Walking speed of a 10 meter walk test

    Time frame: Through study completion, a period of 8 months

    Walking speed during a 10 meter walk test

  4. Duration of backward counting during walking (dual task)

    Time frame: Through study completion, a period of 8 months

    Duration of the cognitive task backward counting

  5. Accuracy of backward counting during walking (dual task)

    Time frame: Through study completion, a period of 8 months

    Accuracy of responses of the cognitive task

  6. Heart rate during walking tasks

    Time frame: Through study completion, a period of 8 months

    Heart rate during 6 minute and 10m walk tests

  7. Rating of Perceived Exertion during walking tasks

    Time frame: 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.

  8. Oxygen consumption (VO2) during 6 minute walk test

    Time frame: Through study completion, a period of 8 months

    VO2 during 6 minute walk test

  9. Visual analogue scale for fatigue during 6 min walk test

    Time frame: 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

  10. Visual analogue scale for comfort during 6 min walk test

    Time frame: 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.

  11. Brain activity

    Time frame: Through study completion, a period of 8 months

    Non-invasive electro-encephalography during walking

  12. Muscle activity

    Time frame: Through study completion, a period of 8 months

    Non-invasive electro-myography during walking

  13. Heart activity

    Time frame: Through study completion, a period of 8 months

    Non-invasive electro-cardiography during walking

  14. Electrodermal activity

    Time frame: Through study completion, a period of 8 months

    Skin sensor during walking determines level of arousal

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 21, 2018
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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