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Not yet recruitingNCT06238505Updated Feb 2, 2024

Acute Efficacy of Exercises Applied With Xbox and Biodex Devices in Pes Planus"

An interventional study of Virtual and biodex in Pes Planus, sponsored by Istanbul Medipol University Hospital. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2024-02-02.

Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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.

Read the detailed description

pes planus can cause symptoms and dysfunction that are symptomatic or severe enough to limit patients' quality of life. Degeneration of the posterior tibial tendon may occur due to trauma, neuroarthropathy, neuromuscular disease and inflammatory arthritis. Among these, the most common cause of pes planus is the degeneration of the posterior tibial tendon.

The highest arch of the foot, the medical longitudinal arch calcaneus, talus, navicular, cuneiform and 1-2-3. It is formed by metatarsals. It is effective in the distribution of the load on the feet. Plantar ligaments are important in protecting the dome of the foot.

They used many definitions known as pes planus, that is, flat feet in the literature. Weak foot, relaxed foot, pes valgus, congenital hypermobile flat foot, hypermobile flat foot, flaccid flat food, talipes calcaneovalgus, compensated talipes equinus can be given as examples.

02

Conditions studied

  • Pes Planus

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Keywords

  • pes planus
  • exercise
03

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Virtual

    Other: Virtual

  • Experimental
    biodex

    Other: biodex

Interventions

  • OtherVirtual

    application will be made with virtual reality device

  • Otherbiodex

    application will be made with biodex device

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

  2. 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. .

    Time frame: 1 day

  3. Foot Pressure Analysis

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

    Time frame: 1 day

  4. 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

    Time frame: 1 day

  5. 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.

    Time frame: 1 day

06

Study locations

1 site
  • Bahçehir University
    Istanbul, Turkey
07

Registry details

Key details

Study ID
NCT06238505
Lead sponsor
Istanbul Medipol University Hospital
Responsible party
hazal genc (Principal Investigator, Istanbul Medipol University Hospital) — Principal investigator
First posted
Feb 2, 2024
Start date
Feb 6, 2024 (estimated)
Primary completion
Feb 6, 2024 (estimated)
Completion
Jul 10, 2024 (estimated)
Last update
Feb 2, 2024

Study contacts

Hazal GENÇ, PhD
Contact
hazaloksuz@gmail.com
+905413204291
Ali Rıza ÇELİK
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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