This Cross-sectional Study Investigates the Relationship Between Different Curve Patterns in Adolescent Idiopathic Scoliosis (AIS) and the Distribution of Foot Pressure. It Aims to Determine Whether Coronal and Sagittal Curve Patterns Are Associated With Asymmetries in Plantar Pressure Distribution

NCT07172048 | Active Not Recruiting

• 1 other identifier: P.T.REC/012/005853
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-sectional study investigates the relationship between different curve patterns in Adolescent Idiopathic Scoliosis (AIS) and the distribution of foot pressure. It aims to determine whether coronal and sagittal curve patterns are associated with asymmetries in plantar pressure distribution during static standing.

Conditions

Scoliosis Idiopathic

Keywords

Scoliosis; Foot Pressure; Scoliosis Curve Pattern

Outcome Measures

Primary Outcomes (1)

• Foot pressure distribution in adolescents with idiopathic scoliosis

  measured using baropodometry during static standing.

  1-2 days

Secondary Outcomes (1)

• Correlation between curve pattern characteristics (e.g., Cobb angle, Central Sacral Vertical Line, Plumb Line) and foot pressure asymmetry.

  2 days

Study Arms (2)

Major Thoracic

The cohort will consist of adolescents aged 10-18 years diagnosed with adolescent idiopathic scoliosis (AIS), with Cobb angles ranging from 10° to 45°, and no prior surgical intervention. Participants will be recruited from orthopedic scoliosis clinics such as ARC for Physiotherapy. The study will involve non-invasive assessments including baropodometric foot pressure analysis and radiographic evaluation of scoliosis curve patterns. No therapeutic intervention will be applied; the study is observational and cross-sectional in nature.

Diagnostic Test: Foot pressure Distribution test

Major Lumbar

The cohort will consist of adolescents aged 10-18 years diagnosed with adolescent idiopathic scoliosis (AIS), with Cobb angles ranging from 10° to 45°, and no prior surgical intervention. Participants will be recruited from orthopedic scoliosis clinics such as ARC for Physiotherapy. The study will involve non-invasive assessments including baropodometric foot pressure analysis and radiographic evaluation of scoliosis curve patterns. No therapeutic intervention will be applied; the study is observational and cross-sectional in nature.

Diagnostic Test: Foot pressure Distribution test

Interventions

Foot pressure Distribution test DIAGNOSTIC_TEST

This study is observational and does not involve any therapeutic or experimental intervention. Participants will be divided into two groups based on their scoliosis curve pattern: Group 1: Adolescents with a major thoracic curve. Group 2: Adolescents with a major lumbar curve. Each participant will undergo non-invasive assessments including: Baropodometric foot pressure analysis during static standing to evaluate pressure distribution in both coronal and sagittal planes. Radiographic evaluation to classify curve patterns using Cobb's angle, Central Sacral Vertical Line, and Plumb Line.

Major Lumbar; Major Thoracic

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population will consist of adolescents aged 10 to 18 years diagnosed with adolescent idiopathic scoliosis (AIS). Participants will be divided into two groups based on their curve pattern: Group 1: Individuals with a major thoracic curve. Group 2: Individuals with a major lumbar curve.

You may qualify if:

• 1- Adolescents aged 10-18 years.
• Diagnosed with idiopathic scoliosis.
• Cobb angle between 10° and 45°.
• No prior surgical intervention for scoliosis.

You may not qualify if:

• 1- Presence of congenital or neuromuscular scoliosis.
• Previous spinal surgery.

Sponsors & Collaborators

• Mahmoud Ibrahim Elsayed Aly Mahmoud: lead
• Advanced Rehabilitation Center, Egypt: collaborator

Study Sites (1)

ARC

Cairo, Cairo Governorate, 12421, Egypt

Location

Related Links

• This study showed that regional plantar foot pressure was significantly higher in AIS patients during quiet standing compared to healthy individuals. AIS patients also had increased pelvic height and altered center-of-pressure trajectories, suggesting po

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 15, 2025
• Study Start: August 1, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Supporting documents (Study Protocol, SAP, ICF, CSR, Analytic Code) will be available starting January 2026, after initial data analysis is completed. They will remain accessible for 5 years, until December 2030, for academic and collaborative purposes upon request.
• Access Criteria: Access to supporting information will be granted to academic researchers, clinicians, and collaborators with a legitimate interest in adolescent idiopathic scoliosis research. Requests must be submitted to the principal investigator and will be reviewed by the research team and ethics committee. Approved documents will be shared via secure institutional email or repository, ensuring confidentiality and ethical compliance.

Locations

EG (1)