NCT06238505

Brief Summary

.Pes planus; It can be defined as the valgus of the hindfoot while loading the foot, the disappearance of the medial longitudinal arch in the midfoot, and the supination of the forefoot relative to the hindfoot. It may also occur due to the fact that the medial longitudinal arch in the foot is lower than the required height according to the anatomical position. The parts of the foot that touch the ground are anatomically healthy in a person; They are the heads of the calcaneus tuberositas calcanei on the back of the foot and the 5 metatarsal bones on the front of the foot. In the standing position, 25% of our body weight is on the tuber calcanei, while 25% is on the 5 metatarsal bones. In individuals with pes planus, convergence of the sole of the midfoot to the ground may even result in the sole of the midfoot touching the ground at its advanced levels. It is one of the common foot deformities.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

February 6, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

February 2, 2024

Status Verified

February 1, 2024

Enrollment Period

Same day

First QC Date

January 26, 2024

Last Update Submit

February 1, 2024

Conditions

Keywords

pes planusexercise

Outcome Measures

Primary Outcomes (5)

  • Biodex device

    The Biodex balance device is a specialized device used for balance training and assessment. It is designed to evaluate and improve an individual's balance, stability and proprioception. The system includes a computerized platform that provides real-time feedback and exercises for balance training. It allows assessment in the anterior and medial and posterior direction.

    1 day

  • Y Balance Test

    The Y Balance Test is a functional movement assessment test used to evaluate a person's dynamic balance, core strength and proprioception ability. The Y Balance Test involves reaching movements in three directions (anterior, posteromedial and posterolateral). The person stands in the center with one leg on a Y-shaped platform and reaches with the other leg in the indicated direction as far as possible while maintaining balance. .

    1 day

  • Foot Pressure Analysis

    These platforms measure the force applied to the sole of the foot and load distribution through electronic sensor

    1 day

  • The Foot Posture Index

    The Foot Posture Index is a six-criteria observational scoring system that provides a necessary measure of foot posture when the patient is standing. This system is a clinical scale for assessing the postural structure of the foot. The anatomical and biomechanical features of the foot are assessed and foot posture is classified as neutral, pronated or supinated. Its calculation consists of six different visual criteria or markers. These criteria include hindfoot position characterized by the subtalar joint, midfoot position, protrusion of the medial longitudinal arch, abduction and adduction of the forefoot, alignment of the toes, and whether the foot is supinated or pronated. Positive scores are given when pronation is observed, while negative scores are given when supination is observed

    1 day

  • Navicular drop

    Navicular drop test is a test used in the evaluation of ankle and lower extremity biomechanics. This test is especially used to provide information about pronation and the placement of the navicular bone. The test includes the following steps: The person stands on a flat surface with bare feet or thin socks. The sole of the feet and ankle position are observed. The ankle and foot structure is observed while the person gives a full load (stands up fully) and walks or strides to compensate for the pressure. How much the navicular bone in the center of the sole of the foot drops under load or during movement is measured.

    1 day

Study Arms (2)

Virtual

EXPERIMENTAL
Other: Virtual

biodex

EXPERIMENTAL
Other: biodex

Interventions

VirtualOTHER

application will be made with virtual reality device

Virtual
biodexOTHER

application will be made with biodex device

biodex

Eligibility Criteria

Age18 Years - 25 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having mild and moderate pes planus,
  • Volunteering of individuals,
  • Being between the age group of 18-25,
  • Having experienced at least one inflammatory symptom (pain, swelling, etc.)
  • Not having any systemic, locomotor and foot related diseases, sensory loss, diabetic and peripheral neuropathy.

You may not qualify if:

  • Having had a serious lower extremity injury in the last 6 months,
  • Getting a full score from the balance test,
  • Having ligament rupture in the ankle.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahçehir University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FlatfootMotor Activity

Interventions

Cadaverine

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Intervention Hierarchy (Ancestors)

Biogenic PolyaminesBiogenic AminesAminesOrganic ChemicalsDiaminesPolyamines

Central Study Contacts

Hazal GENÇ, PhD

CONTACT

Ali Rıza ÇELİK

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2024

First Posted

February 2, 2024

Study Start

February 6, 2024

Primary Completion

February 6, 2024

Study Completion

July 10, 2024

Last Updated

February 2, 2024

Record last verified: 2024-02

Locations