Obesity, MorbidNCT05519436
Investigation of the Relationship Between Plantar Foot Pressure and Balance in Morbidly Obese Individuals
An observational study of Obesity, Morbid and Foot Deformities, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid, Foot Deformities
- What is being tested?
- Assessment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship Between Plantar Foot Pressure and Balance in Morbidly Obese Individuals: A Retrospective Study
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.
- Conditions
- Obesity, Morbid, Foot Deformities
- Being tested
- Assessment
- Keywords
- plantar pressure, dynamic balance, morbid obesiy, gait
- Medical subject headings
- Obesity, Morbid, Foot Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Morbid obesity individuals | Not described Receives: Other: Assessment | |
| Healthy individuals | Not described Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2019-2020
Secondary outcomes (2)
Bioelectrical Impedance Analysis (BIA) Measurement
The muscle, fat, and water ratio of the cases were evaluated with the Inbody Bioelectrical Impedance Device.
Measured: 2019-2020
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.
Measured: 2019-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Sep 2019
- Primary completion1 Oct 2020
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulfidan Tokgoz, Istanbul University - Cerrahpasa
- Investigators
- Gulfıdan Tokgoz, Principal investigator, Istanbul University - CerrahpasaNilay Arman, Principal investigator, Istanbul University - CerrahpasaAyşenur Namlı, Principal investigator, Istanbul University - CerrahpasaHakan Seyit, Principal investigator, BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITALMehmet Karabulut, Principal investigator, BAKIRKOY DR. SADİ KONUK EDUCATION AND RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519436
- Sponsor's protocol ID
- 2022/242
- Status last verified
- Mar 2024
- First submitted
- 25 Aug 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Plantar Foot Pressure and Balance in Morbidly Obese Individuals: A Retrospective Study
- ClinicalTrials.gov ID
- NCT05519436
- Acronym / sponsor ID
- 2022/242
- Conditions
- Obesity, Morbid, Foot Deformities
- Keywords
- plantar pressure, dynamic balance, morbid obesiy, gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morbid obesity individuals | – | Other: Assessment |
| Healthy individuals | – | Other: Assessment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentBioelectrical 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. | Other | Healthy individuals, Morbid obesity individuals |
Primary outcome
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.
2 secondary outcomes
Bioelectrical Impedance Analysis (BIA) Measurement
Time frame: 2019-2020
Biodex Balance System
Time frame: 2019-2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 25429323Elrazek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulfıdan Tokgoz principal investigator
Istanbul University - Cerrahpasa
Nilay Arman principal investigator
Istanbul University - Cerrahpasa
Ayşenur Namlı principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and Foot Deformities, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static and dynamic plantar pressure analyzes (time frame: 2019-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05519436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.