Clinical trial NCT05519436: Investigation of the Relationship Between Plantar Foot Pressure and Balance in Morbidly Obese Individuals
Official title: Investigation of the Relationship Between Plantar Foot Pressure and Balance in Morbidly Obese Individuals: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Foot Deformities
Keywords: plantar pressure
dynamic balance
morbid obesiy
gait
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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).

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Static and dynamic plantar pressure analyzes
timeFrame: 2019-2020
Secondary outcomes:
measure: Bioelectrical Impedance Analysis (BIA) Measurement
timeFrame: 2019-2020
measure: Biodex Balance System
timeFrame: 2019-2020
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Gulfıdan Tokgoz
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Nilay Arman
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Ayşenur Namlı
role: PRINCIPAL_INVESTIGATOR
affiliation: BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL
name: Hakan Seyit
role: PRINCIPAL_INVESTIGATOR
affiliation: BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL
name: Mehmet Karabulut
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.