Shifting and Distribution of Foot Pressure Among Obese Subjects

NCT ID: NCT03441763

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-15

Study Completion Date

2019-05-30

Brief Summary

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Background: The foot is considered a sensitive structure of musculoskeletal system that bears significant loads of the body weight during walking. So, the evaluation of the body weights on planter pressure distribution during walking among adult obese subjects is very critical for foot dysfunctions.The aims:To evaluate the planter pressure distribution in normal ,over weight and obese adult during dynamic situation. Subjects and Methods: A one-hundred fifty normal adult (male and female) subjects will be recruited in this study. They will be divided into Group-I: includes 50 normal subjects Group-II: includes 50 of over weight subjects.group-III 50 obese adult subjects The all three groups will be detected according to the individual BMI. The details of the study will be explained to each participant and a consent form was signed by each subject.Each participant should be free from any musculoskeletal or locomotors disorders Conclusion: Results of this study can help physical therapists to understand the foot pressure distribution map for normal , over weight and obese and non-obese subjects to detect any foot abnormalities and detect any causes of foot dysfunctions.

Detailed Description

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A one hundred fifty volunteers (male and female), age from 20 to 40 years old subjects will be recruited in this study. Demographic data of all participating subjects like age, weight, height, feet size, and body mass index (BMI) will be assessed. All participants will be assigned to three groups per measurement of individual BMI: Group-I: includes 50 normal subjects (18.5 -24.9 BMI); Group-II: includes50 overweight subjects (25.0 -29.9 BMI); Group-III: includes 50 obese subjects (30.0 and Above BMI) (Nuttall, 2015). The procedure and purpose of the study will be explained in details for all participants. A consent form will be signed by each participant. Human research already approved by Institutional review board of Imam Abdulrahman Bin Faisal University(University of dammam previously ).IRB.2017- 03-065.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Normal participants

Emed foot device 3 times/measure to determine foot pressure in normal participants. .

Group Type EXPERIMENTAL

Emed foot device

Intervention Type DEVICE

foot pressure will be measure by using emed foot pressure system

Over weight participants

Emed foot device 3 times/measure to determine foot pressure in over weight participants.

Group Type EXPERIMENTAL

Emed foot device

Intervention Type DEVICE

foot pressure will be measure by using emed foot pressure system

Obese participants

Emed foot device 3 times/measure foot pressure in obese participants.

Group Type EXPERIMENTAL

Emed foot device

Intervention Type DEVICE

foot pressure will be measure by using emed foot pressure system

Interventions

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Emed foot device

foot pressure will be measure by using emed foot pressure system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Subjects who are normal or over weight or obese . Subjects who are free from any musculoskeletal abnormalities .

Exclusion Criteria

Subjects has any foot deformity, flat foot, acute lower extremity trauma, lower extremity surgery like prosthesis operations of the hip, knee, ankle or foot, Subjects has problems of cooperation including; eye, ear oar cognitive disorders, diabetes or related peripheral neuropathy, vascular insufficiency, walking aids .

Subjects has age greater than 40 or less than 25 years.
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role lead

Responsible Party

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Alsayed Abd Elhameed Shanb

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alsayed A Shanb, PhD

Role: PRINCIPAL_INVESTIGATOR

Imam Abdulrahman Bin Faisal University

Locations

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University of Dammam

Dammam, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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Stess RM, Jensen SR, Mirmiran R. The role of dynamic plantar pressures in diabetic foot ulcers. Diabetes Care. 1997 May;20(5):855-8. doi: 10.2337/diacare.20.5.855.

Reference Type BACKGROUND
PMID: 9135955 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/18337103

doi: 10.1016/j.gaitpost.2008.01.012. Epub 2008 M

Other Identifiers

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2017-03-065

Identifier Type: -

Identifier Source: org_study_id

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