Scoliosis Idiopathic AdolescentAIS-PFMTNCT07742670
Effect of Pelvic Floor Muscle Training Combined With Scoliosis-Specific Three-Dimensional Exercises in Adolescents With Idiopathic Scoliosis
A study testing Scoliosis-Specific Three-Dimensional Exercise and Pelvic Floor Muscle Training in people with Scoliosis Idiopathic Adolescent and Scoliosis,Idiopathic,Adolescent, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the effects of scoliosis-specific three-dimensional exercises combined with pelvic floor muscle training on scoliosis severity and spinopelvic parameters in adolescents with idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic Adolescent, Scoliosis,Idiopathic,Adolescent
- What is being tested?
- Scoliosis-Specific Three-Dimensional Exercise and Pelvic Floor Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2024to Oct 2026
- Phase
- Interventional
- 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
Who may be able to join
- Aged 10-18 years.
- Diagnosed with adolescent idiopathic scoliosis and eligible for brace treatment.
- Cobb angle between 20° and 45°.
- Risser sign between 0 and 3.
- Able to comply with and regularly attend the assigned treatment program.
- No neurological or psychiatric disorder.
- Willing to participate in the study, with written assent from the participant and informed consent from a parent or legal guardian.
Who cannot join
- Any contraindication to exercise.
- Previous surgery involving the thoracic, abdominal, or pelvic region.
- Previous scoliosis surgery or being a candidate for scoliosis surgery.
- Any cognitive or mental condition that could prevent understanding or following the treatment program.
- Non-idiopathic scoliosis, including neurological, congenital, or other secondary causes.
- Receipt of any scoliosis treatment or pelvic floor muscle training within the previous year.
- Diagnosis of urinary incontinence.
- Regular participation in sports.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Education and Research Hospital
Istanbul, Gaziosmanpasa, 34255
About this study
Official title: Effects of Scoliosis-Specific Three-Dimensional Exercises Combined With Pelvic Floor Muscle Training on Scoliosis Severity and Spinopelvic Parameters in Adolescents With Idiopathic Scoliosis
The goal of this clinical trial is to evaluate the effects of scoliosis-specific three-dimensional exercises combined with pelvic floor muscle training on scoliosis severity and spinopelvic parameters in adolescents with idiopathic scoliosis. The main questions it aims to answer are:
- Does the addition of pelvic floor muscle training to scoliosis-specific three-dimensional exercises improve scoliosis severity compared with scoliosis-specific three-dimensional exercises alone?
- Does the addition of pelvic floor muscle training improve spinopelvic parameters compared with scoliosis-specific three-dimensional exercises alone? Researchers will compare a scoliosis-specific three-dimensional exercise plus pelvic floor muscle training group with a scoliosis-specific three-dimensional exercise group to determine whether the combined intervention provides additional clinical benefits.
Read more
Participants will:
- undergo baseline clinical and radiographic assessments;
- be randomly assigned to one of the two intervention groups;
- receive supervised treatment for 3 months according to the assigned intervention;
- undergo follow-up clinical and radiographic assessments at the end of the intervention period.
Read the detailed description
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity characterized by lateral curvature of the spine, vertebral rotation, and alterations in sagittal alignment. Conservative treatment, including scoliosis-specific three-dimensional exercises, is widely recommended for individuals with mild to moderate AIS to reduce curve progression and improve postural alignment and function.
The pelvic floor muscles contribute to lumbopelvic stability through their interaction with the diaphragm, abdominal muscles, and paraspinal muscles. Although alterations in trunk muscle function have been reported in individuals with AIS, the potential role of pelvic floor muscle training as an adjunct to scoliosis-specific exercise programs has not been adequately investigated.
This randomized controlled trial will compare scoliosis-specific three-dimensional exercises combined with pelvic floor muscle training versus scoliosis-specific three-dimensional exercises alone in adolescents with idiopathic scoliosis. The study will evaluate the effects of these interventions on scoliosis severity and spinopelvic parameters after a 3-month treatment period. The findings may contribute to optimizing conservative rehabilitation strategies for adolescents with idiopathic scoliosis.
- Being tested
- Scoliosis-Specific Three-Dimensional Exercise, Pelvic Floor Muscle Training
- Keywords
- scoliosis, Spinopelvic Parameters, Pelvic Floor Muscle Training, Physiotherapeutic Scoliosis-Specific Exercises (PSSE)
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scoliosis-Specific Three-Dimensional ExerciseBehavioural
Supervised scoliosis-specific three-dimensional exercises administered twice weekly for 3 months, with additional home exercises according to the study protocol.
Pelvic Floor Muscle TrainingBehavioural
Supervised pelvic floor muscle training performed in combination with scoliosis-specific three-dimensional exercises twice weekly for 3 months, with additional home exercises according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Scoliosis-Specific Three-Dimensional Exercise | Active comparator | Participants received supervised scoliosis-specific three-dimensional exercises for 3 months according to the study protocol. Receives: Behavioral: Scoliosis-Specific Three-Dimensional Exercise |
| Scoliosis-Specific Three-Dimensional Exercise + Pelvic Floor Muscle Training | Experimental | Participants received supervised scoliosis-specific three-dimensional exercises combined with pelvic floor muscle training for 3 months according to the study protocol. Receives: Behavioral: Scoliosis-Specific Three-Dimensional Exercise; Behavioral: Pelvic Floor Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb Angle
Change in Cobb angle measured on standing posteroanterior spinal radiographs using the Cobb method.
Measured: Baseline and 3 months
Secondary outcomes (5)
Angle of Trunk Rotation
Change in angle of trunk rotation measured in degrees using a Baseline® scoliometer during the Adams forward bend test. Thoracic and lumbar measurements will be recorded where applicable.
Measured: Baseline and 3 months
Apical Vertebral Rotation
Change in apical vertebral rotation measured in degrees on spinal radiographs using the Raimondi method.
Measured: Baseline and 3 months
Pelvic Parameters
Changes in pelvic incidence (PI), pelvic tilt (PT), and sacral slope (SS) measured on standing lateral spinal radiographs. Pelvic incidence is defined as the angle between the line perpendicular to the sacral endplate and the line connecting the center of the sacral endplate to the femoral head axis. Pelvic tilt is defined as the angle between the vertical line and the line connecting the center of the sacral endplate to the femoral head axis. Sacral slope is defined as the angle between the sacral endplate and the horizontal plane. All parameters are measured in degrees.
Measured: Baseline and 3 months
Pelvic Floor Muscle Activity
Change in pelvic floor muscle activity assessed using surface electromyography. Pelvic floor muscle activation during contraction and resting periods will be recorded according to the study assessment protocol. Higher activation values indicate greater pelvic floor muscle activity.
Measured: Baseline and 3 months
Sagittal Spinal Alignment Parameters
Changes in thoracic kyphosis (T3-T12 Cobb angle), lumbar lordosis (L1-S1 Cobb angle), cervical lordosis (C2-C7 Cobb angle), and sagittal vertical axis (SVA) measured on standing lateral spinal radiographs. Thoracic kyphosis, lumbar lordosis, and cervical lordosis are measured in degrees using the Cobb method. Sagittal vertical axis is measured as the horizontal distance between the C7 plumb line and the posterosuperior corner of S1 and is reported in millimeters.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start12 May 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis Idiopathic AdolescentStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel intervention groups. One group received scoliosis-specific three-dimensional exercises, while the other received scoliosis-specific three-dimensional exercises combined with pelvic floor muscle training. Both interventions were administered over a 3-month period, and outcomes were assessed before and after treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Başar, Gazi University
- Investigators
- Selda Başar, PhD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742670
- Sponsor's protocol ID
- 2023-1038
- Other IDs
- TDK-2023-8892
- Acronym
- AIS-PFMT
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared to protect participant privacy and confidentiality, particularly given the adolescent study population.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Scoliosis-Specific Three-Dimensional Exercises Combined With Pelvic Floor Muscle Training on Scoliosis Severity and Spinopelvic Parameters in Adolescents With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT07742670
- Acronym / sponsor ID
- AIS-PFMT / 2023-1038
- Keywords
- scoliosis, Spinopelvic Parameters, Pelvic Floor Muscle Training, Physiotherapeutic Scoliosis-Specific Exercises (PSSE)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 12 May 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 3 Aug 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.
The goal of this clinical trial is to evaluate the effects of scoliosis-specific three-dimensional exercises combined with pelvic floor muscle training on scoliosis severity and spinopelvic parameters in adolescents with idiopathic scoliosis. The main questions it aims to answer are:
- Does the addition of pelvic floor muscle training to scoliosis-specific three-dimensional exercises improve scoliosis severity compared with scoliosis-specific three-dimensional exercises alone?
- Does the addition of pelvic floor muscle training improve spinopelvic parameters compared with scoliosis-specific three-dimensional exercises alone? Researchers will compare a scoliosis-specific three-dimensional exercise plus pelvic floor muscle training group with a scoliosis-specific three-dimensional exercise group to determine whether the combined intervention provides additional clinical benefits.
Participants will:
- undergo baseline clinical and radiographic assessments;
- be randomly assigned to one of the two intervention groups;
- receive supervised treatment for 3 months according to the assigned intervention;
- undergo follow-up clinical and radiographic assessments at the end of the intervention period.
Detailed description
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity characterized by lateral curvature of the spine, vertebral rotation, and alterations in sagittal alignment. Conservative treatment, including scoliosis-specific three-dimensional exercises, is widely recommended for individuals with mild to moderate AIS to reduce curve progression and improve postural alignment and function.
The pelvic floor muscles contribute to lumbopelvic stability through their interaction with the diaphragm, abdominal muscles, and paraspinal muscles. Although alterations in trunk muscle function have been reported in individuals with AIS, the potential role of pelvic floor muscle training as an adjunct to scoliosis-specific exercise programs has not been adequately investigated.
This randomized controlled trial will compare scoliosis-specific three-dimensional exercises combined with pelvic floor muscle training versus scoliosis-specific three-dimensional exercises alone in adolescents with idiopathic scoliosis. The study will evaluate the effects of these interventions on scoliosis severity and spinopelvic parameters after a 3-month treatment period. The findings may contribute to optimizing conservative rehabilitation strategies for adolescents with idiopathic scoliosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel intervention groups. One group received scoliosis-specific three-dimensional exercises, while the other received scoliosis-specific three-dimensional exercises combined with pelvic floor muscle training. Both interventions were administered over a 3-month period, and outcomes were assessed before and after treatment.
| Arm | Type | Receives |
|---|---|---|
| Scoliosis-Specific Three-Dimensional Exercise | Active comparator | Behavioral: Scoliosis-Specific Three-Dimensional ExerciseParticipants received supervised scoliosis-specific three-dimensional exercises for 3 months according to the study protocol. |
| Scoliosis-Specific Three-Dimensional Exercise + Pelvic Floor Muscle Training | Experimental | Behavioral: Scoliosis-Specific Three-Dimensional Exercise, Behavioral: Pelvic Floor Muscle TrainingParticipants received supervised scoliosis-specific three-dimensional exercises combined with pelvic floor muscle training for 3 months according to the study protocol. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Aged 10-18 years.
- Diagnosed with adolescent idiopathic scoliosis and eligible for brace treatment.
- Cobb angle between 20° and 45°.
- Risser sign between 0 and 3.
- Able to comply with and regularly attend the assigned treatment program.
Key exclusion criteria (8 listed)
- Any contraindication to exercise.
- Previous surgery involving the thoracic, abdominal, or pelvic region.
- Previous scoliosis surgery or being a candidate for scoliosis surgery.
- Any cognitive or mental condition that could prevent understanding or following the treatment program.
- Non-idiopathic scoliosis, including neurological, congenital, or other secondary causes.
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 |
|---|---|---|
| Scoliosis-Specific Three-Dimensional ExerciseSupervised scoliosis-specific three-dimensional exercises administered twice weekly for 3 months, with additional home exercises according to the study protocol. | Behavioural | Scoliosis-Specific Three-Dimensional Exercise, Scoliosis-Specific Three-Dimensional Exercise + Pelvic Floor Muscle Training |
| Pelvic Floor Muscle TrainingSupervised pelvic floor muscle training performed in combination with scoliosis-specific three-dimensional exercises twice weekly for 3 months, with additional home exercises according to the study protocol. | Behavioural | Scoliosis-Specific Three-Dimensional Exercise + Pelvic Floor Muscle Training |
Primary outcome
Cobb Angle
Time frame: Baseline and 3 months
Change in Cobb angle measured on standing posteroanterior spinal radiographs using the Cobb method.
5 secondary outcomes
Angle of Trunk Rotation
Time frame: Baseline and 3 months
Apical Vertebral Rotation
Time frame: Baseline and 3 months
Pelvic Parameters
Time frame: Baseline and 3 months
Pelvic Floor Muscle Activity
Time frame: Baseline and 3 months
Sagittal Spinal Alignment Parameters
Time frame: Baseline and 3 months
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 4 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared to protect participant privacy and confidentiality, particularly given the adolescent study population.
Related trials for Scoliosis Idiopathic Adolescent
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Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
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Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
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Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for AIS
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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.
Selda Başar, PhD principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scoliosis-Specific Three-Dimensional Exercise and Pelvic Floor Muscle Training in people with Scoliosis Idiopathic Adolescent and Scoliosis,Idiopathic,Adolescent, run by Gazi University 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 8 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 4 Aug 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?
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?
Cobb Angle (time frame: Baseline and 3 months). 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 4 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.