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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03756831
Other study ID # 2378388561
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2, 2018
Est. completion date January 10, 2019

Study information

Verified date March 2019
Source University of Jazan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will be conducted to investigate the influence of body mass index (BMI) on core stability (CS) in healthy subjects. The participants in this study will be 90 healthy subjects with right dominant lower limb (49 females and 49 males) they will be recruited from College of Applied Medical Sciences, Jazan University.


Description:

Subjects will be categorized according to BMI into three groups:

Group I (normal subjects): 30 individuals (15 male, and 15 female students) with (BMI<25 kg//m^2)) Group II (overweight subjects): 30 individuals (15 male, and 15 female students) with (BMI, 25-30 kg//m^2)).

Group III (obese subjects): 30 individuals (15 male, and 15 female students) (BMI>30 kg//m^2)).

Motor control element of CS will be investigated by assessing bilateral static balance with open and close eye, right foot balance test, and dynamic balance test using Prokin System for balance. Data of this study will be statistically analyzed by performing descriptive (Mean and standard deviation) and inferential statistics (One way ANOVA, Unpaired T test) at level of significance p=<0.05.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date January 10, 2019
Est. primary completion date January 3, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 25 Years
Eligibility Inclusion Criteria:

1. Subjects would not have any diseases of the central nervous system.

2. Subjects would not have any orthopedic disorders either of the trunk or the lower limbs in the previous year.

3. None of the subjects has history of balance training ( Erkmen et al., 2010, Li Li, 2012) .

Exclusion Criteria:

1. Sign of foot pain, reduced tactile and thermal foot sensibility.

2. Peripheral neuropathy.

3. A history of previous back or abdominal surgery/injury

4. A history of patellofemoral pain syndrome, plantar fasciitis, and back pain .

5. Limb-length discrepancy, and anterior or posterior tibialis dysfunction.

6. Evidence of a systemic or musculoskeletal disease within the past six months (AlAbdulwahab & Kachanathu, 2016).

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Core Stability Assessment
Core Stability Assessment will be consisted of bilateral static balance with open and close eye, right foot balance test, and dynamic balance test.

Locations

Country Name City State
Saudi Arabia Jazan University Riyadh Jazan

Sponsors (2)

Lead Sponsor Collaborator
Wafaa Mahmoud Amin Cairo University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Static balance test with eyes opened After explaining the tests to the subjects, data will be entered and the device will be calibrated. Both feet of the subjects will be placed on the balance platform nakedly with eyes are opened. 30 Seconds
Primary Static balance test with eyes closed After explaining the tests to the subjects, data will be entered and the device will be calibrated. Both feet of the subjects will be placed on the balance platform nakedly with eyes closed. 30 Seconds
Primary Unipedal static balance It will be measured respectively on right foot with eyes are opened. 30 Seconds
Primary Dynamic (Equilibrium/ Disequilibrium test) the subject will stand on right foot(dominant), and see some galleries that come against. The subject's scope is to enter into those galleries and to maintain the tilting board as firm as possible. 60 Seconds
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