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Clinical Trials/NCT05819567
NCT05819567
Not Yet Recruiting
N/A

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

Vrije Universiteit Brussel1 site in 1 country15 target enrollmentApril 2023
ConditionsHealthy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Healthy
Sponsor
Vrije Universiteit Brussel
Enrollment
15
Locations
1
Primary Endpoint
Longitudinal Arch Angle (LAA)
Status
Not Yet Recruiting
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 2023
End Date
September 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Scafoglieri Aldo

Professor

Vrije Universiteit Brussel

Eligibility Criteria

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

Outcomes

Primary Outcomes

Longitudinal Arch Angle (LAA)

Time Frame: 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.

Study Sites (1)

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