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

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05519436
• Other study ID #: 2022/242
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: July 31, 2023

Study information

• Verified date: March 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 31, 2023
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Foot Deformities
• Obesity, Morbid

Intervention

Other:
• Assessment
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.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2019-2020
Secondary	Bioelectrical Impedance Analysis (BIA) Measurement	The muscle, fat, and water ratio of the cases were evaluated with the Inbody Bioelectrical Impedance Device.	2019-2020
Secondary	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.	2019-2020