CClinicalTrials.gg
Not yet recruitingNCT05819567Updated Apr 24, 2023

Effect of a Newly Developed Brace on Foot Biomechanics.

An interventional study of Newly Developed Ankle Brace in Healthy, sponsored by Vrije Universiteit Brussel. Not yet recruiting at 1 site in Belgium. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-24.

Sponsored by Vrije Universiteit Brussel · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Apr 2023, 3 years 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Healthy

Keywords

  • Ankle Brace
  • Fasciitis, Plantar
  • Dynamic Computed Tomography
  • Subtalar Joint Kinematics
03

In context

Lead sponsor

Vrije Universiteit Brussel is the lead sponsor of 154 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteers;
  • 18\<Age\<60;
  • No gender restrictions;

Exclusion criteria

Exclusion Criteria:

  • Symptoms in their lower limbs in the past 6 months
  • History of foot and/or ankle conditions and/or surgery
  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Healthy Subjects

    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

    Device: Newly Developed Ankle Brace

Interventions

  • DeviceNewly Developed Ankle Brace

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 Day

07

Study locations

1 site
  • Vrije Universiteit Brussel
    Brussels, 1000, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05819567
Lead sponsor
Vrije Universiteit Brussel
Collaborators
Universitair Ziekenhuis Brussel
Responsible party
Scafoglieri Aldo (Professor, Vrije Universiteit Brussel) — Principal investigator
First posted
Apr 19, 2023
Start date
Apr 2023 (estimated)
Primary completion
Apr 2023 (estimated)
Completion
Sep 2023 (estimated)
Last update
Apr 24, 2023

Study contacts

Aldo Scafoglieri, Professor
Contact
aldo.scafoglieri@vub.be
0478/68.26.78
Aldo Scafoglieri, Professor
principal investigator · Vrije Universiteit Brussel

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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