ClinicalTrials.gg
CompletedNCT05519436Updated Mar 6, 2024

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

An observational study in Obesity, Morbid and Foot Deformities, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by Istanbul University - Cerrahpasa · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
60
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Obesity, Morbid
  • Foot Deformities

Keywords

  • plantar pressure
  • dynamic balance
  • morbid obesiy
  • gait
03

In context

Obesity, Morbid

941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 311 observational studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Morbid obesity (grade 3 or severe obesity), a type of obesity, is defined as BMI equal to or more than 40 kg/m2, and chronic diseases such as increased mortality, diabetes mellitus, hypertension, sleep apnea, cardiovascular, kidney, and lung diseases. It is associated with increased risk of musculoskeletal system diseases and dyslipidemia (3,4).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals between the ages of 18-60
  • ≥ 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Morbid obesity individuals

    Other: Assessment

  • Healthy individuals

    Other: Assessment

Interventions

  • OtherAssessment

    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.

06

What researchers measure

Primary outcomes

  1. Static and dynamic plantar pressure analyzes

    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.

    Time frame: 2019-2020

Secondary outcomes

  1. Bioelectrical Impedance Analysis (BIA) Measurement

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

    Time frame: 2019-2020

  2. Biodex Balance System

    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.

    Time frame: 2019-2020

07

Study locations

1 site
  • Istanbul University-Cerrahpaşa
    İstanbul, Turkey
08

References and documents

Publications

  • Elrazek AE, Elbanna AE, Bilasy SE. Medical management of patients after bariatric surgery: Principles and guidelines. World J Gastrointest Surg. 2014 Nov 27;6(11):220-8. doi: 10.4240/wjgs.v6.i11.220. PubMed 25429323 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05519436
Responsible party
Gulfidan Tokgoz (Lecturer, Department of therapy and rehabilitation, PhD student, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Aug 29, 2022
Start date
Sep 1, 2019
Primary completion
Oct 1, 2020
Completion
Jul 31, 2023
Last update
Mar 6, 2024

Study contacts

Gulfıdan Tokgoz
principal investigator · Istanbul University - Cerrahpasa
Nilay Arman
principal investigator · Istanbul University - Cerrahpasa
Ayşenur Namlı
principal investigator · Istanbul University - Cerrahpasa
Hakan Seyit
principal investigator · BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL
Mehmet Karabulut
principal investigator · BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL

Oversight

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

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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