Overweight and ObesityNCT03756831
The Influence of BMI on Core Stability in Healthy Adults
A study testing Core Stability Assessment in people with Overweight and Obesity and Balance; Distorted, run by Wafaa Mahmoud Amin at 1 site in Saudi Arabia.
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… Read more about this study
- Who is it for?
- Ages 19 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Balance; Distorted
- What is being tested?
- Core Stability Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 2 Dec 2018to 10 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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) .
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Overweight and Obesity, Balance; Distorted
- Being tested
- Core Stability Assessment
- Keywords
- BMI, Core Stability, Healthy Adult
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stability AssessmentDiagnostic test
Also called Balance Assessment
Core Stability Assessment will be consisted of bilateral static balance with open and close eye, right foot balance test, and dynamic balance test.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Core Stability Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 Seconds
Unipedal static balance
It will be measured respectively on right foot with eyes are opened.
Measured: 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.
Measured: 60 Seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start2 Dec 2018
- Primary completion3 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wafaa Mahmoud Amin
- Sponsor type
- Other government
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Wafaa Mahmoud Amin, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756831
- Sponsor's protocol ID
- 2378388561
- Status last verified
- Mar 2019
- First submitted
- 23 Nov 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of BMI on Core Stability in Healthy Adults
- ClinicalTrials.gov ID
- NCT03756831
- Acronym / sponsor ID
- 2378388561
- Conditions
- Overweight and Obesity, Balance; Distorted
- Keywords
- BMI, Core Stability, Healthy Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Wafaa Mahmoud AminOther government
- Collaborators
- Cairo University
- Study start
- 2 Dec 2018 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Group I (normal subjects) | Active comparator | Diagnostic Test: Core Stability Assessment30 individuals (15 male, and 15 female students) with (BMI<25 kg//m^2)). Core Stability Assessment will be performed for them using Prokin system. |
| Group II (overweight subjects) | Active comparator | Diagnostic Test: Core Stability Assessment30 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. |
| Group III (obese subjects) | Active comparator | Diagnostic Test: Core Stability Assessment30 individuals (15 male, and 15 female students) (BMI>30 kg//m^2)). Core Stability Assessment will be performed for them using Prokin system. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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) .
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Stability AssessmentAlso: Balance AssessmentCore Stability Assessment will be consisted of bilateral static balance with open and close eye, right foot balance test, and dynamic balance test. | Diagnostic test | Group I (normal subjects), Group II (overweight subjects), Group III (obese subjects) |
Primary outcome
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.
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.
Unipedal static balance
Time frame: 30 Seconds
It will be measured respectively on right foot with eyes are opened.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Stability Assessment in people with Overweight and Obesity and Balance; Distorted, run by Wafaa Mahmoud Amin at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static balance test with eyes opened (time frame: 30 Seconds). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.