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Effect of a Newly Developed Brace on Foot Biomechanics.

V

Vrije Universiteit Brussel

Status

Not yet enrolling

Conditions

Healthy

Treatments

Device: Newly Developed Ankle Brace

Study type

Interventional

Funder types

Other

Identifiers

NCT05819567
23086_BraceAACO

Details and patient eligibility

About

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.

Full 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).

Enrollment

15 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Healthy Subjects
Experimental group
Description:
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
Treatment:
Device: Newly Developed Ankle Brace

Trial contacts and locations

1

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Central trial contact

Aldo Scafoglieri, Professor

Data sourced from clinicaltrials.gov

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