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

NCT ID: NCT07172048

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study Objectives Primary Objective: To assess the correlation between curve pattern and foot pressure percentage in the coronal plane.

Secondary Objective: To assess the correlation between curve pattern and foot pressure percentage in the sagittal plane.

Study Design Type: Observational (Cross-sectional) Model: two Group Time Perspective: Cross-Sectional Statistical Analysis: Pearson correlation coefficient will be used to determine the strength and direction of the relationship.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Scoliosis Idiopathic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Foot pressure Distribution test

Intervention Type 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

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.

Foot pressure Distribution test

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Foot pressure Distribution 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* • 1- Adolescents aged 10-18 years.

* 2- Diagnosed with idiopathic scoliosis.
* 3- Cobb angle between 10° and 45°.
* 4- No prior surgical intervention for scoliosis.

Exclusion Criteria

* • 1- Presence of congenital or neuromuscular scoliosis.

* 2- Previous spinal surgery.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Advanced Rehabilitation Center, Egypt

OTHER

Sponsor Role collaborator

Mahmoud Ibrahim Elsayed Aly Mahmoud

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mahmoud Ibrahim Elsayed Aly Mahmoud

Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ARC

Cairo, Cairo Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Related Links

Access external resources that provide additional context or updates about the study.

https://link.springer.com/content/pdf/10.1007/s13530-014-0197-6.pdf

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P.T.REC/012/005853

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.