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The Influence of BMI on Core Stability in Healthy Adults

Primary Purpose

Overweight and Obesity, Balance; Distorted

Status

Completed

Phase

Not Applicable

Locations

Saudi Arabia

Study Type

Interventional

Intervention

Core Stability Assessment

About this trial

This is an interventional diagnostic trial for Overweight and Obesity focused on measuring BMI, Core Stability, Healthy Adult

Eligibility Criteria

19 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Jazan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Group I (normal subjects)

Group II (overweight subjects)

Group III (obese subjects)

Arm Description

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.

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.

30 individuals (15 male, and 15 female students) (BMI>30 kg//m^2)). Core Stability Assessment will be performed for them using Prokin system.

Outcomes

Primary Outcome Measures

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.

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.

Unipedal static balance

It will be measured respectively on right foot with eyes are opened.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03756831

First Posted

November 23, 2018

Last Updated

March 10, 2019

Sponsor

Wafaa Mahmoud Amin

Collaborators

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03756831

Brief Title

The Influence of BMI on Core Stability in Healthy Adults

Official Title

The Influence of BMI on Core Stability in Healthy Adults

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

December 2, 2018 (Actual)

Primary Completion Date

January 3, 2019 (Actual)

Study Completion Date

January 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Wafaa Mahmoud Amin

Collaborators

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity, Balance; Distorted

Keywords

BMI, Core Stability, Healthy Adult

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

3x3 factorial design, according to body mass index (Independent variable)subjects will be divided into three groups (Group I - normal subjects-BMI<25 kg/m2, Group II -overweight subjects-BMI, 25-30 kg/m2), Group III -obese subjects- BMI>30 kg/m2). Core stability (dependent variable) will be measured by three tests : bilateral static balance with open and close eye, uni-pedal static balance test, and dynamic balance test using Prokin System for balance

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I (normal subjects)

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Group II (overweight subjects)

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Group III (obese subjects)

Arm Type

Active Comparator

Arm Description

30 individuals (15 male, and 15 female students) (BMI>30 kg//m^2)). Core Stability Assessment will be performed for them using Prokin system.

Intervention Type

Diagnostic Test

Intervention Name(s)

Core Stability Assessment

Other Intervention Name(s)

Balance Assessment

Intervention Description

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

Primary Outcome Measure Information:

Title

Static balance test with eyes opened

Description

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.

Time Frame

30 Seconds

Title

Static balance test with eyes closed

Description

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.

Time Frame

30 Seconds

Title

Unipedal static balance

Description

It will be measured respectively on right foot with eyes are opened.

Time Frame

30 Seconds

Title

Dynamic (Equilibrium/ Disequilibrium test)

Description

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.

Time Frame

60 Seconds

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Facility Information:

Facility Name

Jazan University

City

Riyadh

State/Province

Jazan

ZIP/Postal Code

45142

Country

Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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The Influence of BMI on Core Stability in Healthy Adults

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