AmputationTDNCT04599530
A Comprehensive Evaluation of a the Talaris Demonstrator
A study testing Talaris Demonstrator in people with Amputation, run by Vrije Universiteit Brussel.
Trial summary
The Talaris Demonstrator is developed in continuation of previous prototypes called the AMPfoot 2.0, 3.0 and 4.0. The main goal of the experiment is to evaluate the effectiveness of TD during daily activities. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- Talaris Demonstrator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 31 Dec 2021
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 25 - 75 years
- Gender: men and women
- Level of amputation: unilateral transfemoral
- Vascular, traumatic, congenital or other cause of amputation
- Completed the rehabilitation program, meaning that participants possess their final prosthesis
- Medicare Functional Classification Level: K2-4
- Participants wear their prosthesis for at least 8 hours/day
Who cannot join
- Any neurological disease
- No upper limb or bilateral amputation
- Stump pain or bad fit of the socket
About this study
Official title: A Comprehensive Evaluation of a New Generation Bionic Foot
The Talaris Demonstrator is developed in continuation of previous prototypes called the AMPfoot 2.0, 3.0 and 4.0. The main goal of the experiment is to evaluate the effectiveness of TD during daily activities.
Read the detailed description
A within study design will be conducted in order to evaluate four different prosthetic devices (current, non-propulsive TDF, propulsive TDF and Cyberlegs) with ten participants.
Prior to the baseline test, a familiarization trial aimed to accustom participants to the experimental protocol, to get used to the measurements and interface of the measurement devices. The baseline experimental trial is implemented to evaluate the current prosthesis during the different tests. The same tests will be performed during the evaluation of the other devices. Participants are asked to perform the following consecutive tasks with ten minutes of rest in between each task. The first task is a stair climbing test where participants' will be asked to ascend and descend a staircase. Participants start in front of the staircase and are asked to ascend and descend as fast as possible. Bilateral handrails are required to allow support when needed. The ascending phase is initiated with the prosthetic side, while the first step of the descending phase is performed with the non-involved leg. The second task is the L-test, where participants are asked to rise from a chair, walk through an office door, turn 90 degrees, walk down a hallway, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter will be covered. The slope walking test assesses the participants' ability to ascend and descend an inclined ramp as fast as possible. For safety reasons bilateral handrails are warranted. Participants start the test in an upright position in front of the ramp and are asked to ascend the ramp, turn around on the platform, descend the ramp and return to the starting position. During a two-minute walk test, participants are asked to respond as fast as possible to a stimulus visualized on a computer screen one meter in front of the treadmill. Finally, a hallway six-minute walk test will be performed on a hallway at a self-selected walking speed, which closely relates to the most efficient walking speed.
In between each test with a novel device, participants need accustom to the novel device to ensure a good alignment and fitting. Participants will be fitted and aligned to the novel device by a physiotherapist and prosthetist.
- Conditions
- Amputation
- Being tested
- Talaris Demonstrator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talaris DemonstratorDevice
The Talaris Demonstrator will be evaluated during daily activities and compared to the current prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Biomechanical | Other | All experimental tasks will be evaluated on biomechanical outcome measures Receives: Device: Talaris Demonstrator |
| Psychological | Other | All experimental tasks will be evaluated on psychological outcome measures Receives: Device: Talaris Demonstrator |
| Physiological | Other | All experimental tasks will be evaluated on biomechanical outcome measures Receives: Device: Talaris Demonstrator |
| Performance | Other | All experimental tasks will be evaluated on biomechanical outcome measures Receives: Device: Talaris Demonstrator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomechanical: step length
Step Length in cm
Measured: 1 year
Biomechanical: cadence
Cadence steps/min
Measured: 1 year
Biomechanical: step width
Step width in cm
Measured: 1 year
Biomechanical: swing phases
in % of gait cycle
Measured: 1 year
Biomechanical: stance phases
in % of gait cycle
Measured: 1 year
Physiological: oxygen consumption
in ml/min/kg
Measured: 1 year
Psychological: Visual Analogue Scale
For Fatigue and Comfort on a scale from 0 to 10
Measured: 1 year
Performance: walking speed
In meter per second
Measured: 1 year
Performance: duration
secondfs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Feb 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- A within Subject Design
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jo Ghillebert, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599530
- Sponsor's protocol ID
- VUB-Axiles
- Acronym
- TD
- Status last verified
- Dec 2020
- First submitted
- 21 Oct 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Evaluation of a New Generation Bionic Foot
- ClinicalTrials.gov ID
- NCT04599530
- Acronym / sponsor ID
- TD / VUB-Axiles
- Conditions
- Amputation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Oct 2020 (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.
The Talaris Demonstrator is developed in continuation of previous prototypes called the AMPfoot 2.0, 3.0 and 4.0. The main goal of the experiment is to evaluate the effectiveness of TD during daily activities.
Detailed description
A within study design will be conducted in order to evaluate four different prosthetic devices (current, non-propulsive TDF, propulsive TDF and Cyberlegs) with ten participants.
Prior to the baseline test, a familiarization trial aimed to accustom participants to the experimental protocol, to get used to the measurements and interface of the measurement devices. The baseline experimental trial is implemented to evaluate the current prosthesis during the different tests. The same tests will be performed during the evaluation of the other devices. Participants are asked to perform the following consecutive tasks with ten minutes of rest in between each task. The first task is a stair climbing test where participants' will be asked to ascend and descend a staircase. Participants start in front of the staircase and are asked to ascend and descend as fast as possible. Bilateral handrails are required to allow support when needed. The ascending phase is initiated with the prosthetic side, while the first step of the descending phase is performed with the non-involved leg. The second task is the L-test, where participants are asked to rise from a chair, walk through an office door, turn 90 degrees, walk down a hallway, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter will be covered. The slope walking test assesses the participants' ability to ascend and descend an inclined ramp as fast as possible. For safety reasons bilateral handrails are warranted. Participants start the test in an upright position in front of the ramp and are asked to ascend the ramp, turn around on the platform, descend the ramp and return to the starting position. During a two-minute walk test, participants are asked to respond as fast as possible to a stimulus visualized on a computer screen one meter in front of the treadmill. Finally, a hallway six-minute walk test will be performed on a hallway at a self-selected walking speed, which closely relates to the most efficient walking speed.
In between each test with a novel device, participants need accustom to the novel device to ensure a good alignment and fitting. Participants will be fitted and aligned to the novel device by a physiotherapist and prosthetist.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A within Subject Design
| Arm | Type | Receives |
|---|---|---|
| Biomechanical | Other | Device: Talaris DemonstratorAll experimental tasks will be evaluated on biomechanical outcome measures |
| Psychological | Other | Device: Talaris DemonstratorAll experimental tasks will be evaluated on psychological outcome measures |
| Physiological | Other | Device: Talaris DemonstratorAll experimental tasks will be evaluated on biomechanical outcome measures |
| Performance | Other | Device: Talaris DemonstratorAll experimental tasks will be evaluated on biomechanical outcome measures |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 25 - 75 years
- Gender: men and women
- Level of amputation: unilateral transfemoral
- Vascular, traumatic, congenital or other cause of amputation
- Completed the rehabilitation program, meaning that participants possess their final prosthesis
Key exclusion criteria (3 listed)
- Any neurological disease
- No upper limb or bilateral amputation
- Stump pain or bad fit of the socket
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 |
|---|---|---|
| Talaris DemonstratorThe Talaris Demonstrator will be evaluated during daily activities and compared to the current prosthesis | Device | Biomechanical, Performance, Physiological, Psychological |
Primary outcome
Biomechanical: step length
Time frame: 1 year
Step Length in cm
Biomechanical: cadence
Time frame: 1 year
Cadence steps/min
Biomechanical: step width
Time frame: 1 year
Step width in cm
Biomechanical: swing phases
Time frame: 1 year
in % of gait cycle
Biomechanical: stance phases
Time frame: 1 year
in % of gait cycle
Physiological: oxygen consumption
Time frame: 1 year
in ml/min/kg
Psychological: Visual Analogue Scale
Time frame: 1 year
For Fatigue and Comfort on a scale from 0 to 10
Performance: walking speed
Time frame: 1 year
In meter per second
Performance: duration
Time frame: 1 year
secondfs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Talaris Demonstrator in people with Amputation, run by Vrije Universiteit Brussel.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Biomechanical: step length (time frame: 1 year). The study lists 9 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 4 Dec 2020.