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Effect of a Newly Developed Brace on Foot Biomechanics.

Effect of a Newly Developed Brace on Foot Biomechanics: An in Vivo Interventional Study With Dynamic Computed Tomography.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05819567
Enrollment
15
Registered
2023-04-19
Start date
2023-04-30
Completion date
2023-09-30
Last updated
2023-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

Brief 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.

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).

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.

Sponsors

Universitair Ziekenhuis Brussel
CollaboratorOTHER
Vrije Universiteit Brussel
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Longitudinal Arch Angle (LAA)1 DayThe 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.

Countries

Belgium

Contacts

Primary ContactAldo Scafoglieri, Professor
aldo.scafoglieri@vub.be0478/68.26.78

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026