NCT03441763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

April 15, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

1.9 years

First QC Date

April 12, 2017

Last Update Submit

April 3, 2020

Conditions

Obesity

Keywords

Foot pressure, Obese, and normal Subjects

Outcome Measures

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

    3 months

Study Arms (3)

Normal participants

EXPERIMENTAL

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

Device: Emed foot device

Over weight participants

EXPERIMENTAL

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

Device: Emed foot device

Obese participants

EXPERIMENTAL

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

Device: Emed foot device

Interventions

Emed foot deviceDEVICE

foot pressure will be measure by using emed foot pressure system

Normal participantsObese participantsOver weight participants

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Dammam

Dammam, Saudi Arabia

Location

Related Publications (1)

  • 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.

    PMID: 9135955BACKGROUND

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alsayed A Shanb, PhD

    Imam Abdulrahman Bin Faisal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 12, 2017

First Posted

February 22, 2018

Study Start

April 15, 2017

Primary Completion

March 15, 2019

Study Completion

May 30, 2019

Last Updated

April 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

The final results only will be shared

Locations

SA(1)