NCT07408843

Brief Summary

This observational study aims to examine the relationship between trunk postural changes measured using a mobile application (Biotonix Posture Assistant) and spinal curvature assessed by radiographic Cobb angle in adolescent females with idiopathic scoliosis. Thirty girls aged 14 to 17 years with moderate scoliosis will undergo a single posture assessment using the mobile application and a standard spinal X-ray. The study seeks to determine whether mobile-based postural measurements can reliably reflect radiological findings, offering a non-invasive and radiation-free option for screening and monitoring spinal posture in adolescents with scoliosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

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

Study Start

First participant enrolled

September 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

January 30, 2026

Last Update Submit

February 6, 2026

Conditions

Keywords

spinal assessment.mobile applicationCobb angleBiotonixAdolescent idiopathic scoliosis

Outcome Measures

Primary Outcomes (1)

  • Correlation between BPA-derived trunk postural parameters and radiographic Cobb angle

    baseline assessment at study enrollment

Secondary Outcomes (1)

  • 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

    baseline assessment at study enrollment

Study Arms (1)

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

Eligibility Criteria

Age14 Years - 17 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale adolescents aged 14-17 years Diagnosed with adolescent idiopathic scoliosis
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Female adolescents aged 14-17 years Diagnosed with adolescent idiopathic scoliosis

You may qualify if:

  • Female adolescents aged 14-17 years
  • Diagnosed with adolescent idiopathic scoliosis
  • Cobb angle between 40° and 60°
  • Ability to stand independently for posture assessment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Badr University in Cairo

Cairo, 11728, Egypt

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 13, 2026

Study Start

September 1, 2024

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations