Lower Limb Amputation Below Knee (Injury)NCT05127993
Comprehensive Evaluation of the Passive Talaris Demonstrator
A study testing Passive Talaris Demonstrator in people with Lower Limb Amputation Below Knee (Injury), run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
The passive Talaris Demonstrator (TD) is developed in continuation of previous prototypes. 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 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Amputation Below Knee (Injury)
- What is being tested?
- Passive Talaris Demonstrator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Jan 2021to 17 Mar 2022
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unilateral transtibial (below knee) amputation
- Unilateral transfemoral (above knee) amputation
- Healthy subject
- Medicare Functional Classification Level: K2-4
Who cannot join
- Any neurological disease
- Upper limb or bilateral amputation
- Stump pain or bad fit of the socket
Trial locations and contacts
1 site in 1 country.
About this study
The passive Talaris Demonstrator (TD) is developed in continuation of previous prototypes. The main goal of the experiment is to evaluate the effectiveness of TD during daily activities.
Read the detailed description
Twenty-eight healthy active participants with an unilateral transtibial amputation will conduct 2 experimental trials (EXP1 \& EXP2) on the same day in a randomized order, i.e. EXP1 with the currently used prosthesis and EXP2 with the passive Talaris Demonstrator. Each experimental trial will include 6 minutes of treadmill walking at 3 different speeds in consecutive blocks of 2 minutes, a slope walking test, a stair climbing test, a L-test and an outdoor walking task.
The six minutes walk test (6MWT) has become one of the most widely used performance-based outcome measures of functional mobility and exercise capacity. Recently, the 6MWT has been found to correlate with single-limb balance time and symmetry of step length in people with amputation. Additionally, the 6MWT distance has been shown to be responsive to functional training interventions in people with lower-limb amputation. Six minutes of treadmill walking at 3 different speeds will be performed. This test will be performed in consecutive blocks of 2 minutes. These consecutive blocks will be walking 2 minutes at self-selected (SS) speed, 2 minutes at 75% of the SS speed and 2 minutes at 125% of the SS speed. These different walking speeds elicit different angular positions of the ankle and activation levels of muscles, and thus might alter the effectiveness of the novel device.
The slope walking test assesses the participants' ability to ascend and descend a 6 m long ramp of 10% inclination 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.
The stair climbing test assesses the participants' ability to ascend and descend a staircase (84 cm total height, 3-step staircase with an average rise of 28 cm and run of 18 cm). Participants start in front of the staircase and are asked to ascend and descend as fast as possible. Again, 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 L-test, requires higher physical activity of the user. During the L-test, participants are asked to rise from a chair, walk 7 meters, turn 90 degrees, walk 3 meters, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter is covered.
- Being tested
- Passive Talaris Demonstrator
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Talaris DemonstratorDevice
The amputee will walk with the passive Talaris Demonstrator, a novel prosthetic foot, designed and built by "Axiles Bionics".
| Study group | Role | What they receive |
|---|---|---|
| Novel prosthesis | Experimental | A unilateral transtibial amputee will conduct experiments with the novel prosthesis followed by experiments with the current prosthesis. Receives: Device: Passive Talaris Demonstrator |
| Current prosthesis | Active comparator | A unilateral transtibial amputee will conduct experiments with the current prosthesis followed by experiments with the novel prosthesis. Receives: Device: Passive Talaris Demonstrator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Heart rate during all tasks
Measured: Through study completion, a period of 4 months
Performance
Time needed to perform the L-test
Measured: Through study completion, a period of 4 months
Performance
Speed during 6 minutes walk test
Measured: Through study completion, a period of 4 months
Physiological
Electromyography: lower limb muscle activity during different movements (% of the MVC)
Measured: Through study completion, a period of 4 months
Physiological
Oxygen consumption during stair climbing, slope walking and during the 6 minutes walk test
Measured: Through study completion, a period of 4 months
Psychological
Visual analogue scale for comfort (score: 0= not comfortable, 100 = comfortable) and fatigue (score: 0= not fatiguing, 100 = fatiguing) during all tasks
Measured: Through study completion, a period of 4 months
Biomechanical
Joint angels and joint angular velocities of hip, knee and ankle joints
Measured: Through study completion, a period of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start21 Jan 2021
- Primary completion17 Mar 2022
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation Below Knee (Injury)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 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
- Investigators
- Kevin De Pauw, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127993
- Sponsor's protocol ID
- BUN143201526629
- Status last verified
- Apr 2022
- First submitted
- 4 Oct 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Evaluation of the Passive Talaris Demonstrator
- ClinicalTrials.gov ID
- NCT05127993
- Acronym / sponsor ID
- BUN143201526629
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 19 Nov 2021 (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 passive Talaris Demonstrator (TD) is developed in continuation of previous prototypes. The main goal of the experiment is to evaluate the effectiveness of TD during daily activities.
Detailed description
Twenty-eight healthy active participants with an unilateral transtibial amputation will conduct 2 experimental trials (EXP1 \& EXP2) on the same day in a randomized order, i.e. EXP1 with the currently used prosthesis and EXP2 with the passive Talaris Demonstrator. Each experimental trial will include 6 minutes of treadmill walking at 3 different speeds in consecutive blocks of 2 minutes, a slope walking test, a stair climbing test, a L-test and an outdoor walking task.
The six minutes walk test (6MWT) has become one of the most widely used performance-based outcome measures of functional mobility and exercise capacity. Recently, the 6MWT has been found to correlate with single-limb balance time and symmetry of step length in people with amputation. Additionally, the 6MWT distance has been shown to be responsive to functional training interventions in people with lower-limb amputation. Six minutes of treadmill walking at 3 different speeds will be performed. This test will be performed in consecutive blocks of 2 minutes. These consecutive blocks will be walking 2 minutes at self-selected (SS) speed, 2 minutes at 75% of the SS speed and 2 minutes at 125% of the SS speed. These different walking speeds elicit different angular positions of the ankle and activation levels of muscles, and thus might alter the effectiveness of the novel device.
The slope walking test assesses the participants' ability to ascend and descend a 6 m long ramp of 10% inclination 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.
The stair climbing test assesses the participants' ability to ascend and descend a staircase (84 cm total height, 3-step staircase with an average rise of 28 cm and run of 18 cm). Participants start in front of the staircase and are asked to ascend and descend as fast as possible. Again, 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 L-test, requires higher physical activity of the user. During the L-test, participants are asked to rise from a chair, walk 7 meters, turn 90 degrees, walk 3 meters, turn 180 degrees and then return in the same way to the seated position. A total distance of 20 meter is covered.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel prosthesis | Experimental | Device: Passive Talaris DemonstratorA unilateral transtibial amputee will conduct experiments with the novel prosthesis followed by experiments with the current prosthesis. |
| Current prosthesis | Active comparator | Device: Passive Talaris DemonstratorA unilateral transtibial amputee will conduct experiments with the current prosthesis followed by experiments with the novel prosthesis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral transtibial (below knee) amputation
- Unilateral transfemoral (above knee) amputation
- Healthy subject
- Medicare Functional Classification Level: K2-4
Key exclusion criteria (3 listed)
- Any neurological disease
- 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 |
|---|---|---|
| Passive Talaris DemonstratorThe amputee will walk with the passive Talaris Demonstrator, a novel prosthetic foot, designed and built by "Axiles Bionics". | Device | Current prosthesis, Novel prosthesis |
Primary outcome
Performance
Time frame: Through study completion, a period of 4 months
Heart rate during all tasks
Performance
Time frame: Through study completion, a period of 4 months
Time needed to perform the L-test
Performance
Time frame: Through study completion, a period of 4 months
Speed during 6 minutes walk test
Physiological
Time frame: Through study completion, a period of 4 months
Electromyography: lower limb muscle activity during different movements (% of the MVC)
Physiological
Time frame: Through study completion, a period of 4 months
Oxygen consumption during stair climbing, slope walking and during the 6 minutes walk test
Psychological
Time frame: Through study completion, a period of 4 months
Visual analogue scale for comfort (score: 0= not comfortable, 100 = comfortable) and fatigue (score: 0= not fatiguing, 100 = fatiguing) during all tasks
Biomechanical
Time frame: Through study completion, a period of 4 months
Joint angels and joint angular velocities of hip, knee and ankle joints
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 29 Apr 2022.
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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.
Kevin De Pauw principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Talaris Demonstrator in people with Lower Limb Amputation Below Knee (Injury), 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 4 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: finished, as of the sponsor's last update on 29 Apr 2022. 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?
Performance (time frame: Through study completion, a period of 4 months). The study lists 7 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 29 Apr 2022.