Scoliosis IdiopathicNCT07172048
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
An observational study of Scoliosis Idiopathic, run by Mahmoud Ibrahim Elsayed Aly Mahmoud at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- Foot pressure Distribution test
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 30 Oct 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- • 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.
Who cannot join
- • 1- Presence of congenital or neuromuscular scoliosis.
- 2- Previous spinal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Foot Pressure Distribution and Curve Pattern in Adolescent Idiopathic Scoliosis
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.
Read the detailed description
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
- Scoliosis Idiopathic
- Being tested
- Foot pressure Distribution test
- Keywords
- Scoliosis, Foot Pressure, Scoliosis Curve Pattern
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot pressure Distribution testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Foot pressure Distribution test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot pressure distribution in adolescents with idiopathic scoliosis
measured using baropodometry during static standing.
Measured: 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.
Identification of any compensatory postural adaptations associated with different curve patterns.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Aug 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Mahmoud Ibrahim Elsayed Aly Mahmoud
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Rehabilitation Center, Egypt
- Responsible party
- Sponsor-investigator, Mahmoud Ibrahim Elsayed Aly Mahmoud, Advanced Rehabilitation Center, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172048
- Sponsor's protocol ID
- P.T.REC/012/005853
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) collected during this study will be treated as confidential and will not be publicly shared. Data will be anonymized using unique participant codes to ensure privacy. Access to IPD will be restricted to the research team and authorized personnel involved in data analysis. No IPD will be shared with third parties or published in a way that could identify participants. Any future data sharing will require additional ethical approval and participant consent.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Foot Pressure Distribution and Curve Pattern in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT07172048
- Acronym / sponsor ID
- P.T.REC/012/005853
- Conditions
- Scoliosis Idiopathic
- Keywords
- Scoliosis, Foot Pressure, Scoliosis Curve Pattern
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Mahmoud Ibrahim Elsayed Aly MahmoudUniversity, hospital or other
- Collaborators
- Advanced Rehabilitation Center, Egypt
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major Thoracic | – | Diagnostic Test: Foot pressure Distribution testThe 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. |
| Major Lumbar | – | Diagnostic Test: Foot pressure Distribution testThe 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- • 1- Adolescents aged 10-18 years.
Key exclusion criteria (2 listed)
- • 1- Presence of congenital or neuromuscular scoliosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot pressure Distribution testThis 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. | Diagnostic test | Major Lumbar, Major Thoracic |
Primary outcome
Foot pressure distribution in adolescents with idiopathic scoliosis
Time frame: 1-2 days
measured using baropodometry during static standing.
1 secondary outcome
Correlation between curve pattern characteristics (e.g., Cobb angle, Central Sacral Vertical Line, Plumb Line) and foot pressure asymmetry.
Time frame: 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- 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 poLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) collected during this study will be treated as confidential and will not be publicly shared. Data will be anonymized using unique participant codes to ensure privacy. Access to IPD will be restricted to the research team and authorized personnel involved in data analysis. No IPD will be shared with third parties or published in a way that could identify participants. Any future data sharing will require additional ethical approval and participant consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic, run by Mahmoud Ibrahim Elsayed Aly Mahmoud at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot pressure distribution in adolescents with idiopathic scoliosis (time frame: 1-2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025; AzTrials last refreshed its copy on 1 Nov 2026.