Adolescent Idiopathic Scoliosis (AIS)AIS-PLANTARNCT07810140
Relationship Between Spinopelvic Parameters and Plantar Pressure in Adolescents With Lenke Type I and V Scoliosis
An observational study of Adolescent Idiopathic Scoliosis (AIS), run by Aslıhan içer at 1 site in Turkey (Türkiye).
Trial summary
Adolescent idiopathic scoliosis (AIS) affects the alignment of the spine and body posture, which can influence balance and the way body weight is distributed through the feet. This observational study aims to examine how different types of spinal curves, specifically Lenke Type I and Type V, are related to foot… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2025to 30 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Adolescents aged 10 to 17 years who have been diagnosed with adolescent idiopathic scoliosis and classified as Lenke Type I or Type V, with a Cobb angle greater than 10 degrees, able to stand and walk independently, and meeting the study's inclusion and exclusion criteria will be included.
Who may be able to join
- Those with a Cobb angle greater than 10 degrees on radiological evaluation
- Those with scoliosis orthoradiographs taken within the last 3 months
- Those aged 10 ≤ age ≤ 17 who have been diagnosed with AIS by a specialist physiatrist
- Those belonging to Lenke classification Type I and V subgroups
- Individuals below the obesity threshold for their age group
- Individuals who can stand and walk independently
- Individuals who voluntarily participate in the study and have parental consent will be included.
Who cannot join
- Diagnosed with scoliosis other than adolescent idiopathic scoliosis
- Deformity in the lower extremities, leg length discrepancy ≥ 1 centimeter, amputation, or orthopedic pathology that could affect weight bearing
- History of spinal or lower extremity surgery
- History of neurological disease affecting sensation, balance, or walking function
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, Istanbul, 34688
About this study
Official title: Evaluation of the Relationship Between Coronal and Sagittal Spinopelvic Parameters and Static and Dynamic Plantar Pressure Distribution in Adolescents With Lenke Type I and Type V Spinal Curvature
Adolescent idiopathic scoliosis (AIS) affects the alignment of the spine and body posture, which can influence balance and the way body weight is distributed through the feet. This observational study aims to examine how different types of spinal curves, specifically Lenke Type I and Type V, are related to foot pressure patterns during standing and walking.
Participants will undergo standard spinal X-rays to measure alignment and a plantar pressure analysis, a simple test performed on a special platform that records how the feet press against the ground. The study will explore the relationship between spinal shape and foot pressure characteristics.
The results of this study are expected to improve understanding of how adolescents adapt to scoliosis and may help guide more effective exercise and rehabilitation programs to improve balance and daily function.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- Scoliosis, Spinopelvic parameters, Plantar pressure, Adolescent, Posture, Balance
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lenke Type I AIS | The participants are adolescents with Lenke Type I idiopathic scoliosis who undergo radiographic and plantar pressure assessments. | |
| Lenke Type V AIS | The participants are adolescents with Lenke Type V idiopathic scoliosis who undergo radiographic and plantar pressure assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between coronal and sagittal spinopelvic parameters and static and dynamic plantar pressure distribution
The relationship between coronal spinal alignment and sagittal spinopelvic parameters measured on radiographs, and static and dynamic plantar pressure distribution measured using a pressure platform in adolescents with idiopathic scoliosis.
Measured: At baseline (single assessment)
Secondary outcomes (1)
Evaluation of Static and Dynamic Plantar Pressure Distribution in Adolescents with Lenke Type I and Type V Idiopathic Scoliosis
Evaluation of static and dynamic plantar pressure distribution parameters in adolescents with Lenke Type I and Lenke Type V adolescent idiopathic scoliosis, classified according to the Lenke system.
Measured: At baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start20 Dec 2025
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aslıhan içer
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Aslıhan içer, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Aslıhan İÇER, MD, Principal investigator, Istanbul Physical Medicine Rehabilitation Training and Research HospitalMerve Damla KORKMAZ, MD, Study chair, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810140
- Sponsor's protocol ID
- 2025/404
- Acronym
- AIS-PLANTAR
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ai D, Jin W, Li J, Xu B, Wang Z, Liu Z, Hu K, Han X, Ye X, Xu R. Influence of curve location and type of adolescent idiopathic scoliosis on static and dynamic plantar pressure. Gait Posture. 2025 Jun;119:39-47. doi: 10.1016/j.gaitpost.2025.02.014. Epub 2025 Feb 17.
PubMed 40020270Ma Q, Lin H, Wang L, Zhao L, Chen M, Wang S, Rao Z, Luo Y. Correlation between spinal coronal balance and static baropodometry in children with adolescent idiopathic scoliosis. Gait Posture. 2020 Jan;75:93-97. doi: 10.1016/j.gaitpost.2019.10.003. Epub 2019 Oct 9.
PubMed 31639614
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Coronal and Sagittal Spinopelvic Parameters and Static and Dynamic Plantar Pressure Distribution in Adolescents With Lenke Type I and Type V Spinal Curvature
- ClinicalTrials.gov ID
- NCT07810140
- Acronym / sponsor ID
- AIS-PLANTAR / 2025/404
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- Scoliosis, Spinopelvic parameters, Plantar pressure, Adolescent, Posture, Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Aslıhan içerOther government
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 9 Sep 2026 (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.
Adolescent idiopathic scoliosis (AIS) affects the alignment of the spine and body posture, which can influence balance and the way body weight is distributed through the feet. This observational study aims to examine how different types of spinal curves, specifically Lenke Type I and Type V, are related to foot pressure patterns during standing and walking.
Participants will undergo standard spinal X-rays to measure alignment and a plantar pressure analysis, a simple test performed on a special platform that records how the feet press against the ground. The study will explore the relationship between spinal shape and foot pressure characteristics.
The results of this study are expected to improve understanding of how adolescents adapt to scoliosis and may help guide more effective exercise and rehabilitation programs to improve balance and daily function.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenke Type I AIS | – | –The participants are adolescents with Lenke Type I idiopathic scoliosis who undergo radiographic and plantar pressure assessments. |
| Lenke Type V AIS | – | –The participants are adolescents with Lenke Type V idiopathic scoliosis who undergo radiographic and plantar pressure assessments. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Adolescents aged 10 to 17 years who have been diagnosed with adolescent idiopathic scoliosis and classified as Lenke Type I or Type V, with a Cobb angle greater than 10 degrees, able to stand and walk independently, and meeting the study's inclusion and exclusion criteria will be included.
Key inclusion criteria (7 listed)
- Those with a Cobb angle greater than 10 degrees on radiological evaluation
- Those with scoliosis orthoradiographs taken within the last 3 months
- Those aged 10 ≤ age ≤ 17 who have been diagnosed with AIS by a specialist physiatrist
- Those belonging to Lenke classification Type I and V subgroups
- Individuals below the obesity threshold for their age group
Key exclusion criteria (4 listed)
- Diagnosed with scoliosis other than adolescent idiopathic scoliosis
- Deformity in the lower extremities, leg length discrepancy ≥ 1 centimeter, amputation, or orthopedic pathology that could affect weight bearing
- History of spinal or lower extremity surgery
- History of neurological disease affecting sensation, balance, or walking function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship between coronal and sagittal spinopelvic parameters and static and dynamic plantar pressure distribution
Time frame: At baseline (single assessment)
The relationship between coronal spinal alignment and sagittal spinopelvic parameters measured on radiographs, and static and dynamic plantar pressure distribution measured using a pressure platform in adolescents with idiopathic scoliosis.
1 secondary outcome
Evaluation of Static and Dynamic Plantar Pressure Distribution in Adolescents with Lenke Type I and Type V Idiopathic Scoliosis
Time frame: At baseline (single assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 40020270Ai D, Jin W, Li J, Xu B, Wang Z, Liu Z, Hu K, Han X, Ye X, Xu R. Influence of curve location and type of adolescent idiopathic scoliosis on static and dynamic plantar pressure. Gait Posture. 2025 Jun;119:39-47. doi: 10.1016/j.gaitpost.2025.02.014. Epub 2025 Feb 17.
- Background: PubMed 31639614Ma Q, Lin H, Wang L, Zhao L, Chen M, Wang S, Rao Z, Luo Y. Correlation between spinal coronal balance and static baropodometry in children with adolescent idiopathic scoliosis. Gait Posture. 2020 Jan;75:93-97. doi: 10.1016/j.gaitpost.2019.10.003. Epub 2019 Oct 9.
- Individual participant dataSharing planned: No
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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.
Aslıhan İÇER, MD principal investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Merve Damla KORKMAZ, MD study chair
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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 Adolescent Idiopathic Scoliosis (AIS), run by Aslıhan içer at 1 site in Turkey (Türkiye).
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 9 Sep 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relationship between coronal and sagittal spinopelvic parameters and static and dynamic plantar pressure distribution (time frame: At baseline (single assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07810140, which also lists 2 linked publications.
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 9 Sep 2026.