Bronchial AsthmaNCT05373511
Assessing Body Posture and Postural Balance Among Young Adults With Bronchial Asthma
An observational study of Bronchial Asthma, run by Centro Universitário Augusto Motta at 1 site in United Arab Emirates.
Trial summary
The purpose of the study is to assess the relationship between body posture and dynamic balance in adults with childhood-onset asthma and compare them to a non-asthmatic control group matched for gender, age, weight, and height. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- 3D/4D spine and posture analysis "DIERS FORMETRIC 4D" ,The Biodex Balance System SD-
- How many people
- 124 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Feb 2022to 22 Apr 2023
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: bronchial asthma -18 years above health group ( non bronchial asthma )
Who may be able to join
- For the healthy subjects referred by a consultant pulmonologist/physician
- age- and gender-matched volunteers were recruited from the community
Who cannot join
- Other health issues, such as cardiorespiratory issues, neurological deficits
- musculoskeletal problems and peripheral vascular diseases\& pregnancy may affect test performance
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Gopala Krishna Alaparthi
Sharjah city, UAE, 27272
About this study
Official title: Evaluation of Body Posture and Postural Balance Among Young Adults With Bronchial Asthma in the United Arab Emirates - A Correlational Cross Sectional Study
The purpose of the study is to assess the relationship between body posture and dynamic balance in adults with childhood-onset asthma and compare them to a non-asthmatic control group matched for gender, age, weight, and height.
Read the detailed description
Participants will sign a consent form and provide personal information such as gender, age, weight, and height for calculating BMI, pulmonary function test, and respiratory muscle strength test, as well as their asthmatic/clinical history. After collecting demographic information and obtaining consent from participants, they will be asked to remove their T-shirts and stand in the usual relaxed standing position facing the opposite side of the machine's window. When the machine is properly positioned, it will take photographs. which will then be converted into three-dimensional images on the computer for further analysis. When the participant is fully dressed and ready, the second test will be performed using the Biodex balance machine. The parameters and testing mode to begin the dynamic balance test will be entered into the machine, and the procedure will begin. The participants will be thanked for their participation and contribution to our study
- Conditions
- Bronchial Asthma
- Being tested
- 3D/4D spine and posture analysis "DIERS FORMETRIC 4D" ,The Biodex Balance System SD-
- Keywords
- body Posture, dynamic Balance, Biodex Balance System, DIERS FORMETRIC 4D posture analysis
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D/4D spine and posture analysis "DIERS FORMETRIC 4D" ,The Biodex Balance System SD-Other
3D/4D spine and posture analysis "DIERS FORMETRIC 4D" for postural analysis assessment
,The Biodex Balance System SD- for balance assessment
| Study group | Role | What they receive |
|---|---|---|
| bronchial asthma | Inclusion criteria:
Participants over the age of 18 who have had mild to moderate bronchial asthma since childhood and have been referred by a pulmonologist or physician
Exclusion criteria:
Participants with other health issues such as cardiorespiratory issues, neurological deficits or diseases such as nerve compressions, any chronic diseases or suffering from respiratory tract infections, participants with a history of previous serious injuries to the musculoskeletal system, which may result in body posture disturbances Any disease that impairs one's sense of balance Receives: Other: 3D/4D spine and posture analysis "DIERS FORMETRIC 4D" ,The Biodex Balance System SD- | |
| non-asthmatic control group: | Inclusion and Exclusion criteria for non-asthmatic control group:
Inclusion criteria:
For the healthy subjects referred by a consultant pulmonologist/physician, age- and gender-matched volunteers were recruited from the community
Exclusion criteria:
Other health issues, such as cardiorespiratory issues, neurological deficits, musculoskeletal problems, and peripheral vascular diseases\& pregnancy may affect test performance. Receives: Other: 3D/4D spine and posture analysis "DIERS FORMETRIC 4D" ,The Biodex Balance System SD- |
What is being measured
The primary outcome is the main question the study is designed to answer.
body posture assessment using DIERS FORMETRIC 4D,
From a single image, the instrument will generate 40 named spine shape parameters, like( lateral deviation (mm), trunk imbalance (mm), shoulder tilt (mm) )
Measured: baseline
postural balance assessment by biodex balance system machine
Double Leg Eyes Open (DLEO) Degree (angle), Double Leg Eyes Closed (DLEC) Degree (angle), Single Leg Eyes Open (SLEO) Degree (angle), single Leg Eyes closed (SLEC) Degree (angle), Overall Balance/stability Index (OBI/OSI )Degree (angle), ANT/POST Balance Index (APBI )Degree (angle), MED/LAT Balance Index (MLBI)Degree (angle),
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start1 Feb 2022
- Primary completion22 Apr 2023
- Study completion22 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchial AsthmaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitário Augusto Motta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur De Sa Ferreira, phd, Study chair, Augusto Motta University Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373511
- Sponsor's protocol ID
- REC-22-01-12
- Status last verified
- Oct 2022
- First submitted
- 15 Apr 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Alaparthi GK, Moustafa IM, Lopes AJ, Ferreira AS. Pulmonary function, body posture and balance in young adults with asthma: A cross-sectional study. PLoS One. 2025 Mar 3;20(3):e0316663. doi: 10.1371/journal.pone.0316663. eCollection 2025.
PubMed 40029906
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Body Posture and Postural Balance Among Young Adults With Bronchial Asthma in the United Arab Emirates - A Correlational Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05373511
- Acronym / sponsor ID
- REC-22-01-12
- Conditions
- Bronchial Asthma
- Keywords
- body Posture, dynamic Balance, Biodex Balance System, DIERS FORMETRIC 4D posture analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Centro Universitário Augusto MottaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 22 Apr 2023 (actual)
- Study completion
- 22 Apr 2023 (actual)
- First posted
- 13 May 2022 (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.
The purpose of the study is to assess the relationship between body posture and dynamic balance in adults with childhood-onset asthma and compare them to a non-asthmatic control group matched for gender, age, weight, and height.
Detailed description
Participants will sign a consent form and provide personal information such as gender, age, weight, and height for calculating BMI, pulmonary function test, and respiratory muscle strength test, as well as their asthmatic/clinical history. After collecting demographic information and obtaining consent from participants, they will be asked to remove their T-shirts and stand in the usual relaxed standing position facing the opposite side of the machine's window. When the machine is properly positioned, it will take photographs. which will then be converted into three-dimensional images on the computer for further analysis. When the participant is fully dressed and ready, the second test will be performed using the Biodex balance machine. The parameters and testing mode to begin the dynamic balance test will be entered into the machine, and the procedure will begin. The participants will be thanked for their participation and contribution to our study
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bronchial asthma | – | Other: 3D/4D spine and posture analysis "DIERS FORMETRIC 4D" ,The Biodex Balance System SD-Inclusion criteria: Participants over the age of 18 who have had mild to moderate bronchial asthma since childhood and have been referred by a pulmonologist or physician Exclusion criteria: Participants with other health issues such as cardiorespiratory issues, neurological deficits or diseases such as nerve compressions, any chronic diseases or suffering from respiratory tract infections, participants with a history of previous serious injuries to the musculoskeletal system, which may result in body posture disturbances Any disease that impairs one's sense of balance |
| non-asthmatic control group: | – | Other: 3D/4D spine and posture analysis "DIERS FORMETRIC 4D" ,The Biodex Balance System SD-Inclusion and Exclusion criteria for non-asthmatic control group: Inclusion criteria: For the healthy subjects referred by a consultant pulmonologist/physician, age- and gender-matched volunteers were recruited from the community Exclusion criteria: Other health issues, such as cardiorespiratory issues, neurological deficits, musculoskeletal problems, and peripheral vascular diseases\& pregnancy may affect test performance. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- bronchial asthma -18 years above health group ( non bronchial asthma )
Key inclusion criteria (2 listed)
- For the healthy subjects referred by a consultant pulmonologist/physician
- age- and gender-matched volunteers were recruited from the community
Key exclusion criteria (2 listed)
- Other health issues, such as cardiorespiratory issues, neurological deficits
- musculoskeletal problems and peripheral vascular diseases\& pregnancy may affect test performance
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 |
|---|---|---|
| 3D/4D spine and posture analysis "DIERS FORMETRIC 4D" ,The Biodex Balance System SD-3D/4D spine and posture analysis "DIERS FORMETRIC 4D" for postural analysis assessment ,The Biodex Balance System SD- for balance assessment | Other | bronchial asthma, non-asthmatic control group: |
Primary outcome
body posture assessment using DIERS FORMETRIC 4D,
Time frame: baseline
From a single image, the instrument will generate 40 named spine shape parameters, like( lateral deviation (mm), trunk imbalance (mm), shoulder tilt (mm) )
postural balance assessment by biodex balance system machine
Time frame: baseline
Double Leg Eyes Open (DLEO) Degree (angle), Double Leg Eyes Closed (DLEC) Degree (angle), Single Leg Eyes Open (SLEO) Degree (angle), single Leg Eyes closed (SLEC) Degree (angle), Overall Balance/stability Index (OBI/OSI )Degree (angle), ANT/POST Balance Index (APBI )Degree (angle), MED/LAT Balance Index (MLBI)Degree (angle),
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 3 May 2023.
- Derived from this study: PubMed 40029906Alaparthi GK, Moustafa IM, Lopes AJ, Ferreira AS. Pulmonary function, body posture and balance in young adults with asthma: A cross-sectional study. PLoS One. 2025 Mar 3;20(3):e0316663. doi: 10.1371/journal.pone.0316663. eCollection 2025.
- Individual participant dataSharing planned: Yes
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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.
Arthur De Sa Ferreira, phd study chair
Augusto Motta University Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma, run by Centro Universitário Augusto Motta at 1 site in United Arab Emirates.
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 2 inclusion and 2 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 3 May 2023. 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 United Arab Emirates. 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?
body posture assessment using DIERS FORMETRIC 4D, (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05373511, which also lists 1 linked publication.
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 3 May 2023.