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Shifting and Distribution of Foot Pressure Among Obese Subjects

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ClinicalTrials.gov Identifier: NCT03441763
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Alsayed Abd Elhameed Shanb, Dammam University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Device: Emed foot device Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Body Weight on Shifting of Foot Pressure Among Obese Subjects
Actual Study Start Date : April 15, 2017
Estimated Primary Completion Date : May 15, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Normal participants
Emed foot device 3 times/measure to determine foot pressure in normal participants. .
Device: Emed foot device
foot pressure will be measure by using emed foot pressure system

Experimental: Over weight participants
Emed foot device 3 times/measure to determine foot pressure in over weight participants.
Device: Emed foot device
foot pressure will be measure by using emed foot pressure system

Experimental: Obese participants
Emed foot device 3 times/measure foot pressure in obese participants.
Device: Emed foot device
foot pressure will be measure by using emed foot pressure system




Primary Outcome Measures :
  1. Foot planter pressure [ Time Frame: 3 months ]
    Foot plantar pressure during walking will be detected in four anatomical foot areas (hindfoot, midfoot, forfoot, toes) for 150 normal and obese person using Emed pressure system



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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441763


Contacts
Contact: Mariam A mahmoud, PhD +966501689402 ext 31350 mamahmoud@ud.edu.sa
Contact: Enas F Youssef, PhD +966555786350 ext 31352 eyoussef@uod.edu.sa

Locations
Saudi Arabia
University of Dammam Recruiting
Dammam, Saudi Arabia
Contact: Mariam A Mahmoud, PhD    +966501689402    mamahmoud@ud.edu.sa   
Sponsors and Collaborators
Dammam University
Investigators
Principal Investigator: Alsayed A Shanb, PhD Imam Abdulrahman Bin Faisal University

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Alsayed Abd Elhameed Shanb, Associate Professor, Dammam University
ClinicalTrials.gov Identifier: NCT03441763     History of Changes
Other Study ID Numbers: 2017-03-065
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The final results only will be shared

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alsayed Abd Elhameed Shanb, Dammam University:
Foot pressure, Obese, and normal Subjects