Effect of a Newly Developed Brace on Foot Biomechanics.

NCT ID: NCT05819567

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2023-09-30

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).

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy Subjects

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

Group Type: EXPERIMENTAL

Newly Developed Ankle Brace

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role: lead

Responsible Party

Scafoglieri Aldo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aldo Scafoglieri, Professor

Role: PRINCIPAL_INVESTIGATOR

Vrije Universiteit Brussel

Locations

Vrije Universiteit Brussel

Brussels, , Belgium

Countries

Belgium

Central Contacts

Aldo Scafoglieri, Professor

Role: CONTACT

aldo.scafoglieri@vub.be

0478/68.26.78

Other Identifiers

23086_BraceAACO

Identifier Type: -

Identifier Source: org_study_id