Adolescent Idiopathic ScoliosisSpinalOrthosisNCT06569030
Effect Spinal Orthosis on Sagittal and Frontal Parameters in Scoliosis
A study testing spinal orthoses in people with Adolescent Idiopathic Scoliosis, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
It has been observed that there are insufficient studies on whether the conservative treatment of AIS with Chêneau spinal orthosis provides 3D correction on the scoliotic curve and its effect on the spine and lower extremity parameters. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- spinal orthoses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Nov 2024to 30 Dec 2025
- Phase
- Interventional
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 10-18 years old
- Cobb angle: 15-45°
- Individuals with AIS who will be using a Chêneau type spinal orthosis for the first time • Spinal orthosis recommended for at least 18 hours per day
- Risser ≤ 3
Who cannot join
- Using a foot orthosis
- Neurological problem
- Surgery history
- Lower extremity length difference greater than 1 cm
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem Üniversitesi Maslak Hastanesi Omurga Sağlık Merkezi
Istanbul
About this study
Official title: Effect of Spinal Orthosis on Sagittal and Frontal Parameters in Adolescent Idiopathic Scoliosis
It has been observed that there are insufficient studies on whether the conservative treatment of AIS with Chêneau spinal orthosis provides 3D correction on the scoliotic curve and its effect on the spine and lower extremity parameters. The aim of this study is to investigate the effect of Chêneau spinal orthosis application on sagittal and frontal parameters at 3 and 6 months follow-up in adolescent idiopathic scoliosis.
Read the detailed description
Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine that is commonly seen in individuals aged 10-18 years, and spinal orthosis application, one of the conservative treatment methods, is widely preferred today. Lyon, Milwaukee, Gensingen, Boston and Rigo System Chêneau spinal orthoses are among the most frequently preferred today. Rigo system Chêneau (RCS) spinal orthosis aims to correct scoliosis in 3D in sagittal, transverse and coronal planes. Studies have indicated that spinal orthosis application may have limited corrective effect on sagittal and transverse planes scoliotic curvature. In order to obtain the most effective result in spinal orthosis application, it is important to fully understand the connection mechanisms between different planes and their relationship with the lower extremity. It has been observed that studies on whether conservative treatment of spinal orthosis in adolescent idiopathic scoliosis (AIS) can provide 3D correction on the scoliotic curve and its effect on spine and lower extremity parameters are insufficient. AIS individuals who will undergo Chêneau type spinal orthosis application that meets the inclusion criteria will be included in the study. Demographic information of the participants will be obtained with a patient information form and a scoliosis assessment form. Radiographs are planned to be obtained using an EOS (EOS-imaging®, Paris, France) imaging device, which is a low-dose imaging device that provides simultaneous anterior-posterior and lateral views while standing. Spine and lower extremity parameters will be evaluated from the obtained images. Plantar pressure and balance assessment is planned to be performed with a DIERS Pedoscan device connected to the DIERS Formetric system. SRS-22 (Scoliosis Research Society-22) questionnaire is planned to be used in the assessment of the quality of life of the individuals. Brace Questionnaire is planned to be used in the assessment of spinal orthosis satisfaction. All data will be evaluated by statistical analysis methods.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- spinal orthoses
- Keywords
- Adolescent Idiopathic Scoliosis, Scoliosis Brace, 3D spine analysis, plantar pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal orthosesBiological
Evaluation of scoliosis treatment in people using spinal orthoses
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Adolescent Idiopathic Scoliosis Who Receive Spinal Orthosis | Other | Not described Receives: Biological: spinal orthoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
EOS-imaging®
Radiographs were planned to be obtained using an EOS (EOS-imaging®, Paris, France) imaging device, which is a low-dose imaging device that provides simultaneous anterior-posterior and lateral views in the standing position. Spine and lower extremity parameters will be evaluated from the obtained image.
Spine parameters; cervical lordosis ( C1C3, C2C6, C3C7), pelvic oblique, pelvic coronal obliquity angle, thoracolumbar kyphosis, lumbar lordosis, pelvic incidence, pelvic tilt, sacral slope, sagittal vertical angle, coronal vertical angle will be evaluated.
Lower Extremity Parameters; hip-knee-ankle angle, medial proximal femoral angle, mechanical lateral distal femoral angle, medial proximal tibial angle, lateral distal tibial angle, lower extremity length, femur length, tibia length, recurvation angle of the knee joint will be measured.
Measured: Change from Baseline of treatment at 3 and 6 months
Spine Rotation Measurement
Trunk Rotation Measurement: Scoliometer; is used during the person's "Adam's Forward Bend Test" to determine the trunk rotation angle.
Measured: Change from Baseline of treatment at 3 and 6 months
DIERS Formetric Pedoscan
Plantar Pressure and Balance Assessment It is planned to be performed with the DIERS Pedoscan device connected to the DIERS Formetric system in plantar pressure and balance assessment. DIERS Pedoscan allows the assessment of foot pressure distribution while standing. It is preferred for measuring plantar pressure changes during the individual's bipedal static stance and walking. There are static, dynamic, postural balance analysis methods in pedobarographic assessment. Numerical data is obtained for foot analysis with these methods.
Measured: Change from Baseline of treatment at 3 and 6 months
Scoliosis Research Society (SRS-22 test)
assessment of quality of life SRS-22 is a scale used to assess the quality of life in individuals with spinal deformity.
Measured: Change from Baseline of treatment at 3 and 6 months
Brace Questionnaire (BrQ)
Evaluation of Spinal Orthosis Satisfaction Brace Questionnaire (BrQ) is a questionnaire used to measure the effect of brace treatment on quality of life in adolescent idiopathic scoliosis.
Measured: Change from Baseline of treatment at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start21 Nov 2024
- Primary completion20 Jul 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merve yılmaz, Istanbul Medipol University Hospital
- Investigators
- Merve Yılmaz, Study director, https://www.medipol.edu.tr/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569030
- Sponsor's protocol ID
- mervearslann
- Acronym
- SpinalOrthosis
- Status last verified
- Jan 2026
- First submitted
- 19 Aug 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Spinal Orthosis on Sagittal and Frontal Parameters in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06569030
- Acronym / sponsor ID
- SpinalOrthosis / mervearslann
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, Scoliosis Brace, 3D spine analysis, plantar pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 23 Aug 2024 (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.
It has been observed that there are insufficient studies on whether the conservative treatment of AIS with Chêneau spinal orthosis provides 3D correction on the scoliotic curve and its effect on the spine and lower extremity parameters. The aim of this study is to investigate the effect of Chêneau spinal orthosis application on sagittal and frontal parameters at 3 and 6 months follow-up in adolescent idiopathic scoliosis.
Detailed description
Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine that is commonly seen in individuals aged 10-18 years, and spinal orthosis application, one of the conservative treatment methods, is widely preferred today. Lyon, Milwaukee, Gensingen, Boston and Rigo System Chêneau spinal orthoses are among the most frequently preferred today. Rigo system Chêneau (RCS) spinal orthosis aims to correct scoliosis in 3D in sagittal, transverse and coronal planes. Studies have indicated that spinal orthosis application may have limited corrective effect on sagittal and transverse planes scoliotic curvature. In order to obtain the most effective result in spinal orthosis application, it is important to fully understand the connection mechanisms between different planes and their relationship with the lower extremity. It has been observed that studies on whether conservative treatment of spinal orthosis in adolescent idiopathic scoliosis (AIS) can provide 3D correction on the scoliotic curve and its effect on spine and lower extremity parameters are insufficient. AIS individuals who will undergo Chêneau type spinal orthosis application that meets the inclusion criteria will be included in the study. Demographic information of the participants will be obtained with a patient information form and a scoliosis assessment form. Radiographs are planned to be obtained using an EOS (EOS-imaging®, Paris, France) imaging device, which is a low-dose imaging device that provides simultaneous anterior-posterior and lateral views while standing. Spine and lower extremity parameters will be evaluated from the obtained images. Plantar pressure and balance assessment is planned to be performed with a DIERS Pedoscan device connected to the DIERS Formetric system. SRS-22 (Scoliosis Research Society-22) questionnaire is planned to be used in the assessment of the quality of life of the individuals. Brace Questionnaire is planned to be used in the assessment of spinal orthosis satisfaction. All data will be evaluated by statistical analysis methods.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with Adolescent Idiopathic Scoliosis Who Receive Spinal Orthosis | Other | Biological: spinal orthoses |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 10-18 years old
- Cobb angle: 15-45°
- Individuals with AIS who will be using a Chêneau type spinal orthosis for the first time • Spinal orthosis recommended for at least 18 hours per day
- Risser ≤ 3
Key exclusion criteria (4 listed)
- Using a foot orthosis
- Neurological problem
- Surgery history
- Lower extremity length difference greater than 1 cm
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 |
|---|---|---|
| spinal orthosesEvaluation of scoliosis treatment in people using spinal orthoses | Biological | Individuals with Adolescent Idiopathic Scoliosis Who Receive Spinal Orthosis |
Primary outcome
EOS-imaging®
Time frame: Change from Baseline of treatment at 3 and 6 months
Radiographs were planned to be obtained using an EOS (EOS-imaging®, Paris, France) imaging device, which is a low-dose imaging device that provides simultaneous anterior-posterior and lateral views in the standing position. Spine and lower extremity parameters will be evaluated from the obtained image. Spine parameters; cervical lordosis ( C1C3, C2C6, C3C7), pelvic oblique, pelvic coronal obliquity angle, thoracolumbar kyphosis, lumbar lordosis, pelvic incidence, pelvic tilt, sacral slope, sagittal vertical angle, coronal vertical angle will be evaluated. Lower Extremity Parameters; hip-knee-ankle angle, medial proximal femoral angle, mechanical lateral distal femoral angle, medial proximal tibial angle, lateral distal tibial angle, lower extremity length, femur length, tibia length, recurvation angle of the knee joint will be measured.
Spine Rotation Measurement
Time frame: Change from Baseline of treatment at 3 and 6 months
Trunk Rotation Measurement: Scoliometer; is used during the person's "Adam's Forward Bend Test" to determine the trunk rotation angle.
DIERS Formetric Pedoscan
Time frame: Change from Baseline of treatment at 3 and 6 months
Plantar Pressure and Balance Assessment It is planned to be performed with the DIERS Pedoscan device connected to the DIERS Formetric system in plantar pressure and balance assessment. DIERS Pedoscan allows the assessment of foot pressure distribution while standing. It is preferred for measuring plantar pressure changes during the individual's bipedal static stance and walking. There are static, dynamic, postural balance analysis methods in pedobarographic assessment. Numerical data is obtained for foot analysis with these methods.
Scoliosis Research Society (SRS-22 test)
Time frame: Change from Baseline of treatment at 3 and 6 months
assessment of quality of life SRS-22 is a scale used to assess the quality of life in individuals with spinal deformity.
Brace Questionnaire (BrQ)
Time frame: Change from Baseline of treatment at 3 and 6 months
Evaluation of Spinal Orthosis Satisfaction Brace Questionnaire (BrQ) is a questionnaire used to measure the effect of brace treatment on quality of life in adolescent idiopathic scoliosis.
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 2 Feb 2026.
- 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.
Merve Yılmaz study director
https://www.medipol.edu.tr/
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal orthoses in people with Adolescent Idiopathic Scoliosis, run by Istanbul Medipol University Hospital 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 4 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 2 Feb 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?
EOS-imaging® (time frame: Change from Baseline of treatment at 3 and 6 months). The study lists 5 primary outcomes in all. 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 2 Feb 2026.