Clinical trial NCT03441763: Shifting and Distribution of Foot Pressure Among Obese Subjects
Official title: Impact of Body Weight on Shifting of Foot Pressure Among Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Foot pressure, Obese, and normal Subjects
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Foot planter pressure
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: University of Dammam
Study officials:
affiliation: Imam Abdulrahman Bin Faisal University
name: Alsayed A Shanb, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.