NCT05373511

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2023

Completed
Last Updated

May 3, 2023

Status Verified

October 1, 2022

Enrollment Period

1.2 years

First QC Date

April 15, 2022

Last Update Submit

April 28, 2023

Conditions

Keywords

body Posturedynamic BalanceBiodex Balance SystemDIERS FORMETRIC 4D posture analysis

Outcome Measures

Primary Outcomes (2)

  • 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) )

    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),

    baseline

Study Arms (2)

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

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.

Other: 3D/4D spine and posture analysis "DIERS FORMETRIC 4D" ,The Biodex Balance System SD-

Interventions

3D/4D spine and posture analysis "DIERS FORMETRIC 4D" for postural analysis assessment ,The Biodex Balance System SD- for balance assessment

bronchial asthmanon-asthmatic control group:

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

bronchial asthma -18 years above health group ( non bronchial asthma )

You may qualify if:

  • For the healthy subjects referred by a consultant pulmonologist/physician
  • age- and gender-matched volunteers were recruited from the community

You may not qualify if:

  • Other health issues, such as cardiorespiratory issues, neurological deficits
  • musculoskeletal problems and peripheral vascular diseases\& pregnancy may affect test performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gopala Krishna Alaparthi

Sharjah city, UAE, 27272, United Arab Emirates

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Arthur De Sa Ferreira, phd

    Augusto Motta University Centre

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2022

First Posted

May 13, 2022

Study Start

February 1, 2022

Primary Completion

April 22, 2023

Study Completion

April 22, 2023

Last Updated

May 3, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
very month
Access Criteria
through mail

Locations