Effect of a Newly Developed Brace on Foot Biomechanics.

NCT05819567 | Unknown

• 1 other identifier: 23086_BraceAACO
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

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.

  1 Day

Study Arms (1)

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

Device: Newly Developed Ankle Brace

Interventions

Newly Developed Ankle Brace DEVICE

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.

Healthy Subjects

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Universitair Ziekenhuis Brussel: collaborator

Study Sites (1)

Vrije Universiteit Brussel

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Aldo Scafoglieri, Professor

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aldo Scafoglieri, Professor

CONTACT

0478/68.26.78; aldo.scafoglieri@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 19, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

BE (1)