- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03756831
The Influence of BMI on Core Stability in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jazan
-
Riyadh, Jazan, Saudi Arabia, 45142
- Jazan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects would not have any diseases of the central nervous system.
- Subjects would not have any orthopedic disorders either of the trunk or the lower limbs in the previous year.
- None of the subjects has history of balance training ( Erkmen et al., 2010, Li Li, 2012) .
Exclusion Criteria:
- Sign of foot pain, reduced tactile and thermal foot sensibility.
- Peripheral neuropathy.
- A history of previous back or abdominal surgery/injury
- A history of patellofemoral pain syndrome, plantar fasciitis, and back pain .
- Limb-length discrepancy, and anterior or posterior tibialis dysfunction.
- Evidence of a systemic or musculoskeletal disease within the past six months (AlAbdulwahab & Kachanathu, 2016).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group I (normal subjects)
30 individuals (15 male, and 15 female students) with (BMI<25 kg//m^2)).
Core Stability Assessment will be performed for them using Prokin system.
|
Core Stability Assessment will be consisted of bilateral static balance with open and close eye, right foot balance test, and dynamic balance test.
Other Names:
|
Active Comparator: Group II (overweight subjects)
30 individuals (15 male, and 15 female students) with (BMI, 25-30 kg//m^2)).
Core Stability Assessment will be performed for them using Prokin system.
|
Core Stability Assessment will be consisted of bilateral static balance with open and close eye, right foot balance test, and dynamic balance test.
Other Names:
|
Active Comparator: Group III (obese subjects)
30 individuals (15 male, and 15 female students) (BMI>30 kg//m^2)).
Core Stability Assessment will be performed for them using Prokin system.
|
Core Stability Assessment will be consisted of bilateral static balance with open and close eye, right foot balance test, and dynamic balance test.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Static balance test with eyes opened
Time Frame: 30 Seconds
|
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
|
Static balance test with eyes closed
Time Frame: 30 Seconds
|
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
|
Unipedal static balance
Time Frame: 30 Seconds
|
It will be measured respectively on right foot with eyes are opened.
|
30 Seconds
|
Dynamic (Equilibrium/ Disequilibrium test)
Time Frame: 60 Seconds
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2378388561
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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