NCT03756831

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

December 2, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

1 month

First QC Date

November 23, 2018

Last Update Submit

March 10, 2019

Conditions

Keywords

BMI, Core Stability, Healthy Adult

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • Unipedal static balance

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

    30 Seconds

  • 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

Study Arms (3)

Group I (normal subjects)

ACTIVE COMPARATOR

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.

Diagnostic Test: Core Stability Assessment

Group II (overweight subjects)

ACTIVE COMPARATOR

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.

Diagnostic Test: Core Stability Assessment

Group III (obese subjects)

ACTIVE COMPARATOR

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

Diagnostic Test: Core Stability Assessment

Interventions

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

Also known as: Balance Assessment
Group I (normal subjects)Group II (overweight subjects)Group III (obese subjects)

Eligibility Criteria

Age19 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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) .

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jazan University

Riyadh, Jazan Region, 45142, Saudi Arabia

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Model Details: 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
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 23, 2018

First Posted

November 28, 2018

Study Start

December 2, 2018

Primary Completion

January 3, 2019

Study Completion

January 10, 2019

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations