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Shifting and Distribution of Foot Pressure Among Obese Subjects

Sponsor
Imam Abdulrahman Bin Faisal University (Other)
Overall Status
Completed
CT.gov ID
NCT03441763
Collaborator
(none)
150
Enrollment
1
Location
3
Arms
25.5
Actual Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Emed foot device
 N/A

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 Design

Study Type:
Interventional
Actual 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 :
Apr 15, 2017
Actual Primary Completion Date :
Mar 15, 2019
Actual Study Completion Date :
May 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Foot planter pressure [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Dammam Dammam Saudi Arabia

Sponsors and Collaborators

  • Imam Abdulrahman Bin Faisal University

Investigators

  • Principal Investigator: Alsayed A Shanb, PhD, Imam Abdulrahman Bin Faisal University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Alsayed Abd Elhameed Shanb, Associate Professor, Imam Abdulrahman Bin Faisal University
ClinicalTrials.gov Identifier:
NCT03441763
Other Study ID Numbers:
  • 2017-03-065
First Posted:
Feb 22, 2018
Last Update Posted:
Apr 7, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Associate Professor, Imam Abdulrahman Bin Faisal University
Foot pressure, Obese, and normal Subjects

Study Results

No Results Posted as of Apr 7, 2020