Prosthesis UserNCT03530956
Evaluation of a Novel Bionic Foot, AMPfoot 4+
A study testing Ankle Mimicking Prosthetic Foot prototype 4+ in people with Prosthesis User and Cognitive Change, run by Vrije Universiteit Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthesis User, Cognitive Change, Physical Activity
- What is being tested?
- Ankle Mimicking Prosthetic Foot prototype 4+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2016to 15 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- unilateral transtibial (below knee) amputee
- healthy subject
- K4-level (Medicare), which means highest ambulation level
Who cannot join
- comorbidities
- pain in stump
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Case Study: Adaptation Period of a Novel Motorized Ankle Prosthesis, 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.
Read more
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.
- Conditions
- Prosthesis User, Cognitive Change, Physical Activity
- Being tested
- Ankle Mimicking Prosthetic Foot prototype 4+
- Keywords
- AMPfoot, dual-task, cognitive performance, physical performance, lower-limb prosthesis
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Current prosthesis | Active comparator | A unilateral transtibial amputee will conduct experiments with the current prosthesis Receives: Device: Ankle Mimicking Prosthetic Foot prototype 4+ |
| Novel prosthesis | Experimental | A unilateral transtibial amputee will conduct experiments with the novel prosthesis Receives: Device: Ankle Mimicking Prosthetic Foot prototype 4+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking distance of a 6 minute walk test
Distance walked during a 6 minute hallway walk test
Measured: Through study completion, a period of 8 months
Walking speed of a 6 minute walk test
Walking speed during a 6 minute walk test
Measured: Through study completion, a period of 8 months
Walking speed of a 10 meter walk test
Walking speed during a 10 meter walk test
Measured: Through study completion, a period of 8 months
Duration of backward counting during walking (dual task)
Duration of the cognitive task backward counting
Measured: Through study completion, a period of 8 months
Accuracy of backward counting during walking (dual task)
Accuracy of responses of the cognitive task
Measured: Through study completion, a period of 8 months
Heart rate during walking tasks
Heart rate during 6 minute and 10m walk tests
Measured: Through study completion, a period of 8 months
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.
Measured: Through study completion, a period of 8 months
Oxygen consumption (VO2) during 6 minute walk test
VO2 during 6 minute walk test
Measured: Through study completion, a period of 8 months
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
Measured: Through study completion, a period of 8 months
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.
Measured: Through study completion, a period of 8 months
Brain activity
Non-invasive electro-encephalography during walking
Measured: Through study completion, a period of 8 months
Muscle activity
Non-invasive electro-myography during walking
Measured: Through study completion, a period of 8 months
Heart activity
Non-invasive electro-cardiography during walking
Measured: Through study completion, a period of 8 months
Electrodermal activity
Skin sensor during walking determines level of arousal
Measured: Through study completion, a period of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start1 Oct 2016
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis UserStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin De Pauw, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530956
- Sponsor's protocol ID
- SRP 17
- Status last verified
- Feb 2019
- First submitted
- 25 Apr 2018
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Case Study: Adaptation Period of a Novel Motorized Ankle Prosthesis, AMPfoot 4+
- ClinicalTrials.gov ID
- NCT03530956
- Acronym / sponsor ID
- SRP 17
- Conditions
- Prosthesis User, Cognitive Change, Physical Activity
- Keywords
- AMPfoot, dual-task, cognitive performance, physical performance, lower-limb prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current prosthesis | Active comparator | Device: Ankle Mimicking Prosthetic Foot prototype 4+A unilateral transtibial amputee will conduct experiments with the current prosthesis |
| Novel prosthesis | Experimental | Device: Ankle Mimicking Prosthetic Foot prototype 4+A unilateral transtibial amputee will conduct experiments with the novel prosthesis |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- unilateral transtibial (below knee) amputee
- healthy subject
- K4-level (Medicare), which means highest ambulation level
Key exclusion criteria (2 listed)
- comorbidities
- pain in stump
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | Current prosthesis, Novel prosthesis |
Primary outcome
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
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
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
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
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
Heart rate during walking tasks
Time frame: Through study completion, a period of 8 months
Heart rate during 6 minute and 10m walk tests
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.
Oxygen consumption (VO2) during 6 minute walk test
Time frame: Through study completion, a period of 8 months
VO2 during 6 minute walk test
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
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.
Brain activity
Time frame: Through study completion, a period of 8 months
Non-invasive electro-encephalography during walking
Muscle activity
Time frame: Through study completion, a period of 8 months
Non-invasive electro-myography during walking
Heart activity
Time frame: Through study completion, a period of 8 months
Non-invasive electro-cardiography during walking
Electrodermal activity
Time frame: Through study completion, a period of 8 months
Skin sensor during walking determines level of arousal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle Mimicking Prosthetic Foot prototype 4+ in people with Prosthesis User and Cognitive Change, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking distance of a 6 minute walk test (time frame: Through study completion, a period of 8 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2019.