- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07408843
Correlation Between Trunk Postural Changes by Mobile Application and Radiological Findings in Adolescent Idiopathic Scoliotic Females (TPSA-S)
Study Overview
Status
Conditions
Detailed Description
Detailed Description
Adolescent idiopathic scoliosis is a common spinal deformity that typically develops during the adolescent growth period and predominantly affects females. Accurate assessment of spinal curvature is essential for clinical decision-making and follow-up; however, repeated radiographic evaluation exposes patients to ionizing radiation. Therefore, non-invasive assessment tools are increasingly needed.
This observational cross-sectional study aims to investigate the relationship between trunk postural deviations measured using the Biotonix Posture Assistant mobile application and radiographic Cobb angle measurements in adolescent females diagnosed with idiopathic scoliosis. Thirty female participants aged 14 to 17 years with moderate scoliosis (Cobb angle between 40° and 60°) will be recruited.
Each participant will undergo a single postural assessment using the mobile application to measure trunk rotation and translation along the X and Y axes while standing in a standardized position. Standard posteroanterior spinal radiographs will be used to determine Cobb angles as part of routine clinical evaluation. No therapeutic intervention will be applied as part of this study.
Statistical analysis will include correlation and regression methods to explore the association between postural parameters obtained from the mobile application and radiographic findings. The results of this study are expected to support the clinical utility of mobile-based posture assessment as a complementary, non-radiographic tool for screening and monitoring spinal deformities in adolescents
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11728
- Badr University in Cairo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Female adolescents aged 14-17 years
Diagnosed with adolescent idiopathic scoliosis
Description
Inclusion Criteria:
Female adolescents aged 14-17 years
Diagnosed with adolescent idiopathic scoliosis
Cobb angle between 40° and 60°
Ability to stand independently for posture assessment
Exclusion Criteria:
Congenital scoliosis
Neuromuscular scoliosis
Previous spinal surgery
Leg length discrepancy greater than 2 cm
Any musculoskeletal disorder affecting posture
Any neurological disorder affecting posture
Thyroid disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Adolescent Idiopathic Scoliosis Group
This group includes female adolescents aged 14 to 17 years diagnosed with moderate adolescent idiopathic scoliosis (Cobb angle 40°-60°).
Participants undergo a single assessment of trunk posture using a mobile application (Biotonix Posture Assistant) and standard posteroanterior spinal radiography as part of routine clinical evaluation.
No therapeutic or experimental intervention is applied in this study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlation between BPA-derived trunk postural parameters and radiographic Cobb angle
Time Frame: baseline assessment at study enrollment
|
baseline assessment at study enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlation between trunk rotation (X and Y axes) and Cobb angle Correlation between trunk translation (X and Y axes) and Cobb angle Predictive value of BPA parameters for Cobb angle estimation
Time Frame: baseline assessment at study enrollment
|
baseline assessment at study enrollment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB0001P4233-41. (Other Identifier: ethical committee from Badr University in Cairo)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adolescent Idiopathic Scoliosis (AIS)
-
Istituto Scientifico Italiano Colonna VertebraleActive, not recruitingAdolescent Idiopathic Scoliosis (AIS)Italy
-
University College, LondonShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University and other collaboratorsNot yet recruitingAdolescent Idiopathic Scoliosis (AIS)
-
Shanghai Jiao Tong University School of MedicineRecruitingAdolescent Idiopathic Scoliosis (AIS) | AdherenceChina
-
National Scoliosis CenterCompletedAdolescent Idiopathic Scoliosis (AIS) | Neuromuscular Scoliosis | Juvenile Idiopathic Scoliosis | Infantile Idiopathic Scoliosis | Ealy Onset ScoliosisUnited States
-
Istituto Scientifico Italiano Colonna VertebraleActive, not recruitingAdolescent Idiopathic Scoliosis (AIS) | Juvenile Idiopathic ScoliosisItaly
-
Ankara City Hospital BilkentCompletedAdolescent Idiopathic Scoliosis (AIS)Turkey (Türkiye)
-
Şahide Eda ArtuçNot yet recruitingAdolescent Idiopathic Scoliosis (AIS) | Exercise (EX)Turkey (Türkiye)
-
Gözde Yagci (Gür)RecruitingAdolescent Idiopathic Scoliosis (AIS)Turkey (Türkiye)
-
Jinan University GuangzhouGuangzhou Women and Children's Medical CenterActive, not recruitingAdolescent Idiopathic Scoliosis (AIS)China
-
Eric ParentWomen and Children's Health Research Institute (WCHRI)Enrolling by invitation