HealthyNCT05819567
Effect of a Newly Developed Brace on Foot Biomechanics.
A study testing Newly Developed Ankle Brace in people with Healthy, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
For this interventional study the investigators will recruit a number of healthy volunteers with no symptoms in their lower limbs in the past 6 months and without history of foot and/or ankle conditions and/or surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Newly Developed Ankle Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2023to Sep 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers;
- 18<Age<60;
- No gender restrictions;
Who cannot join
- Symptoms in their lower limbs in the past 6 months
- History of foot and/or ankle conditions and/or surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Newly Developed Brace on Foot Biomechanics: An in Vivo Interventional Study With Dynamic Computed Tomography.
For this interventional study the investigators will recruit a number of healthy volunteers with no symptoms in their lower limbs in the past 6 months and without history of foot and/or ankle conditions and/or surgery. These volunteers will undergo a single Dynamic Computerized Tomography scan session before and after the support is carried, to find out if there is a change in the kinematics of the foot. The results will be analyzed statistically.
Read the detailed description
For this study the investigators will recruit 15 healthy volunteers who will be undergone a single Dynamic Computed Tomography (4DCT) scanning session before and after wearing a brace, in order to find out if there is a change in foot kinematics. Between the two scans, the subjects will wear the brace and walk for 1 minute. Data collected with the 4DCT will be processed to get 3D imaging of the Subtalar and Midtarsal Joints, needed to quantify the rotations in the three planes of the space (Cardan Angles).
- Conditions
- Healthy
- Being tested
- Newly Developed Ankle Brace
- Keywords
- Ankle Brace, Fasciitis, Plantar, Dynamic Computed Tomography, Subtalar Joint Kinematics
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newly Developed Ankle BraceDevice
The ankle brace is made of gripping tissue and includes two straps and one latex wedge. The purpose of this brace is to lift up the plantar arch.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Experimental | Students and employees of the Vrije Universiteit Brussel as well as people from outside this institution will be recruited (via Flyer), contacted and asked if they will want to participate. No gender restrictions will be applied, the participants must be adult (18<age <60) and healthy.
Inclusion Criteria:
* Healthy volunteers;
* 18<Age<60;
* Exclusion Criteria:
* Symptoms in their lower limbs in the past 6 months
* History of foot and/or ankle conditions and/or surgery
* Pregnancy Receives: Device: Newly Developed Ankle Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Arch Angle (LAA)
The Longitudinal Arch Angle (LAA) is a static measurement and is the angle defined by two vectors: the first vector passing through the midpoint of the medial malleolus to the navicular tuberosity; the second passing through the midpoint of the medial aspect of the first metatarsal head to the navicular tuberosity. The value of the LAA allowed us to identify the type of foot in one of these three categories: with LAA less than 130° is considered a pronated foot posture; with a LAA between 130° and 150° is considered a typical foot structures; with LAA greater than 150° is considered a supinated foot.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Responsible party
- Principal investigator, Scafoglieri Aldo, Vrije Universiteit Brussel
- Investigators
- Aldo Scafoglieri, Professor, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819567
- Sponsor's protocol ID
- 23086_BraceAACO
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Newly Developed Brace on Foot Biomechanics: An in Vivo Interventional Study With Dynamic Computed Tomography.
- ClinicalTrials.gov ID
- NCT05819567
- Acronym / sponsor ID
- 23086_BraceAACO
- Conditions
- Healthy
- Keywords
- Ankle Brace, Fasciitis, Plantar, Dynamic Computed Tomography, Subtalar Joint Kinematics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 19 Apr 2023 (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.
For this interventional study the investigators will recruit a number of healthy volunteers with no symptoms in their lower limbs in the past 6 months and without history of foot and/or ankle conditions and/or surgery. These volunteers will undergo a single Dynamic Computerized Tomography scan session before and after the support is carried, to find out if there is a change in the kinematics of the foot. The results will be analyzed statistically.
Detailed description
For this study the investigators will recruit 15 healthy volunteers who will be undergone a single Dynamic Computed Tomography (4DCT) scanning session before and after wearing a brace, in order to find out if there is a change in foot kinematics. Between the two scans, the subjects will wear the brace and walk for 1 minute. Data collected with the 4DCT will be processed to get 3D imaging of the Subtalar and Midtarsal Joints, needed to quantify the rotations in the three planes of the space (Cardan Angles).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Experimental | Device: Newly Developed Ankle BraceStudents and employees of the Vrije Universiteit Brussel as well as people from outside this institution will be recruited (via Flyer), contacted and asked if they will want to participate. No gender restrictions will be applied, the participants must be adult (18<age <60) and healthy. Inclusion Criteria: * Healthy volunteers; * 18<Age<60; * Exclusion Criteria: * Symptoms in their lower limbs in the past 6 months * History of foot and/or ankle conditions and/or surgery * Pregnancy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers;
- 18<Age<60;
- No gender restrictions;
Key exclusion criteria (3 listed)
- Symptoms in their lower limbs in the past 6 months
- History of foot and/or ankle conditions and/or surgery
- Pregnancy
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 |
|---|---|---|
| Newly Developed Ankle BraceThe ankle brace is made of gripping tissue and includes two straps and one latex wedge. The purpose of this brace is to lift up the plantar arch. | Device | Healthy Subjects |
Primary outcome
Longitudinal Arch Angle (LAA)
Time frame: 1 Day
The Longitudinal Arch Angle (LAA) is a static measurement and is the angle defined by two vectors: the first vector passing through the midpoint of the medial malleolus to the navicular tuberosity; the second passing through the midpoint of the medial aspect of the first metatarsal head to the navicular tuberosity. The value of the LAA allowed us to identify the type of foot in one of these three categories: with LAA less than 130° is considered a pronated foot posture; with a LAA between 130° and 150° is considered a typical foot structures; with LAA greater than 150° is considered a supinated foot.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
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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.
Aldo Scafoglieri, Professor 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 Newly Developed Ankle Brace in people with Healthy, 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 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 24 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aldo Scafoglieri, Professor (0478/68.26.78, aldo.scafoglieri@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal Arch Angle (LAA) (time frame: 1 Day). 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 24 Apr 2023.