Effect of a Newly Developed Brace on Foot Biomechanics.

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Device: Newly Developed Ankle Brace

• Registration Number: NCT05819567
• Lead Sponsor: Vrije Universiteit Brussel

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).

Study Timeline

• Status Verified: 2023-04
• Study Start: 2023-04
• Primary Completion: 2023-04
• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-19
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-24
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Subjects	Newly Developed Ankle Brace	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

Primary Outcome Measures

Name	Time	Method
Longitudinal Arch Angle (LAA)	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.

Trial Locations

Locations (1)

Vrije Universiteit Brussel; 🇧🇪 Brussels, Belgium