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CompletedNCT03441763Updated Apr 7, 2020

Shifting and Distribution of Foot Pressure Among Obese Subjects

An interventional study of Emed foot device in Obesity, sponsored by Imam Abdulrahman Bin Faisal University. Completed at 1 site in Saudi Arabia. Open to participants aged 25 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-07.

Sponsored by Imam Abdulrahman Bin Faisal University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
25 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity

Keywords

  • Foot pressure, Obese, and normal Subjects
03

Who can participate

Ages eligible
25 Years to 40 Years
Sexes eligible
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

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.

04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Normal participants

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

    Device: Emed foot device

  • Experimental
    Over weight participants

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

    Device: Emed foot device

  • Experimental
    Obese participants

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

    Device: Emed foot device

Interventions

  • DeviceEmed foot device

    foot pressure will be measure by using emed foot pressure system

05

What researchers measure

Primary outcomes

  1. Foot planter pressure

    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

    Time frame: 3 months

06

Study locations

1 site
  • University of Dammam
    Dammam, Saudi Arabia
07

References and documents

Publications

  • 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. PubMed 9135955 ↗

Individual participant data

Plan to share: No — The final results only will be shared

08

Registry details

Key details

Study ID
NCT03441763
Lead sponsor
Imam Abdulrahman Bin Faisal University
Responsible party
Alsayed Abd Elhameed Shanb (Associate Professor, Imam Abdulrahman Bin Faisal University) — Principal investigator
First posted
Feb 22, 2018
Start date
Apr 15, 2017
Primary completion
Mar 15, 2019
Completion
May 30, 2019
Last update
Apr 7, 2020

Study contacts

Alsayed A Shanb, PhD
principal investigator · Imam Abdulrahman Bin Faisal University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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