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Completed

NCT Number: NCT05519436

Investigation of the Relationship Between Plantar Foot Pressure and Balance in Morbidly Obese Individuals

The fact that changes in plantar pressure during walking and in a fixed position in morbidly obese individuals and the relationship between postural oscillations and balance have not been fully elucidated creates a need in this area.

In this study, primary aim is to investigate the change in plantar foot pressure, balance parameters and the relationship between them in morbidly obese individuals compared to healthy individuals.

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Key information

Conditions

Obesity, Morbid Body Weight Foot Deformities Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals between the ages of 18-60
  • BMI ≥ 40 kg/m2, morbidly obese individual
  • No surgical operation in the last 6 months
  • Non-obese healthy adult individuals will be included in the study as the control group.

Exclusion criteria

  • Having a musculoskeletal disorder or systemic disease that will interfere with physical activity
  • Presence of balance problems that will prevent physical activity
  • Presence of psychiatric or neurological disease affecting cooperation and cognitive functions
  • Presence of acute pain
  • Presence of uncontrolled diabetes and hypertension
  • Having any communication problems

Treatment and study plan

Assessment

Other

Bioelectrical impedance analysis method was used to evaluate the body composition of the cases. Muscle, fat, water ratio was made with Inbody Bioelectrical Impedance Device. Static and dynamic plantar pressure analyzes were evaluated with Sensor Medica pedobarographic measuring device, and postural sway was evaluated with "bilateral comparison tests", one of the dynamic balance tests of Biodex Balance System.

Primary outcomes

  1. Static and dynamic plantar pressure analyzes

    Time frame: 2019-2020

    To evaluate the plantar pressure, a computerized pedobarographic measuring device with a pressure sensor platform, which can measure the load on the sole of the foot statically and dynamically, and detect the displacement of the pressure center while standing, was used.

Secondary outcomes

  1. Bioelectrical Impedance Analysis (BIA) Measurement

    Time frame: 2019-2020

    The muscle, fat, and water ratio of the cases were evaluated with the Inbody Bioelectrical Impedance Device.

  2. Biodex Balance System

    Time frame: 2019-2020

    Biodex Balance System is a system that provides the opportunity to evaluate the balance statically and dynamically. It allows to measure the displacements in the center of gravity of the patient standing on a standing balance platform and the reactions when the support surface changes. "Bilateral comparison tests", one of the dynamic balance tests of the Biodex balance System, were used to evaluate the postural sway of the cases.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Investigation of the Relationship Between Plantar Foot Pressure and Balance in Morbidly Obese Individuals: A Retrospective Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Aug 29, 2022
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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