NCT05519436

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

August 25, 2022

Last Update Submit

March 5, 2024

Conditions

Obesity, MorbidFoot Deformities

Keywords

plantar pressuredynamic balancemorbid obesiygait

Outcome Measures

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.

    2019-2020

Secondary Outcomes (2)

  • Bioelectrical Impedance Analysis (BIA) Measurement

    2019-2020

  • Biodex Balance System

    2019-2020

Study Arms (2)

Morbid obesity individuals

Other: Assessment

Healthy individuals

Other: Assessment

Interventions

AssessmentOTHER

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.

Healthy individualsMorbid obesity individuals

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related 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.

    PMID: 25429323BACKGROUND

MeSH Terms

Conditions

Obesity, MorbidFoot Deformities

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Gulfıdan Tokgoz

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

  • Nilay Arman

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

  • Ayşenur Namlı

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

  • Hakan Seyit

    BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL

    PRINCIPAL INVESTIGATOR

  • Mehmet Karabulut

    BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Department of therapy and rehabilitation, PhD student

Study Record Dates

First Submitted

August 25, 2022

First Posted

August 29, 2022

Study Start

September 1, 2019

Primary Completion

October 1, 2020

Study Completion

July 31, 2023

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

TU(1)