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NCT Number: NCT07742670

Effect of Pelvic Floor Muscle Training Combined With Scoliosis-Specific Three-Dimensional Exercises 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.

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Scoliosis Idiopathic Adolescent Bone Diseases Musculoskeletal Diseases Scoliosis Scoliosis,Idiopathic,Adolescent Spinal Curvatures Spinal Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpasa Education and Research Hospital

Istanbul, Gaziosmanpasa, 34255, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Scoliosis-Specific Three-Dimensional Exercise

Behavioral

Supervised scoliosis-specific three-dimensional exercises administered twice weekly for 3 months, with additional home exercises according to the study protocol.

Pelvic floor muscle training

Behavioral

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.

Primary outcomes

  1. Cobb Angle

    Time frame: Baseline and 3 months

    Change in Cobb angle measured on standing posteroanterior spinal radiographs using the Cobb method.

Secondary outcomes

  1. Angle of Trunk Rotation

    Time frame: Baseline and 3 months

    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.

  2. Apical Vertebral Rotation

    Time frame: Baseline and 3 months

    Change in apical vertebral rotation measured in degrees on spinal radiographs using the Raimondi method.

  3. Pelvic Parameters

    Time frame: Baseline and 3 months

    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.

  4. Pelvic Floor Muscle Activity

    Time frame: Baseline and 3 months

    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.

  5. Sagittal Spinal Alignment Parameters

    Time frame: Baseline and 3 months

    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.

Other outcomes

  1. Trunk Appearance Perception (TAPS) Scale

    Time frame: Baseline and 3 months

    Change in self-perceived trunk appearance assessed using the Trunk Appearance Perception Scale (TAPS). The TAPS consists of three drawings representing different views of the trunk. Each drawing is scored from 1 to 5, and the final score is calculated as the sum of the three scores divided by 3, resulting in a total score ranging from 1 to 5. Higher scores indicate better perceived trunk appearance and less perceived trunk deformity.

  2. Trunk Aesthetic Clinical Evaluation (TRACE) Score

    Time frame: Baseline and 3 months

    Change in trunk aesthetics assessed by the clinician using the Trunk Aesthetic Clinical Evaluation (TRACE). The scale evaluates shoulder, scapular, waist, and hemithorax asymmetry. The TRACE score ranges from 0 to 12, with higher scores indicating greater trunk asymmetry and a worse aesthetic outcome.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Collaborators

  • Gazi University Scientific Research Unit

Registry information

Official study 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

Acronym: AIS-PFMT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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