Effect of a Newly Developed Brace on Foot Biomechanics.

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05819567
• Other study ID #: 23086_BraceAACO
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: September 2023

Study information

• Verified date: April 2023
• Source: Vrije Universiteit Brussel
• Contact: Aldo Scafoglieri, Professor
• Phone: 0478/68.26.78
• Email: aldo.scafoglieri[@]vub.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: September 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Newly 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.

Locations

Country	Name	City	State
Belgium	Vrije Universiteit Brussel	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel	Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 Day