Effect of Pelvic Floor Muscle Training Combined With Scoliosis-Specific Three-Dimensional Exercises in Adolescents With Idiopathic Scoliosis

NCT07742670 | Active Not Recruiting

• 2 other identifiers: 2023-1038TDK-2023-8892
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Scoliosis Idiopathic Adolescent; Scoliosis,Idiopathic,Adolescent

Keywords

scoliosis; Spinopelvic Parameters; Pelvic Floor Muscle Training; Physiotherapeutic Scoliosis-Specific Exercises (PSSE)

Outcome Measures

Primary Outcomes (1)

• Cobb Angle

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

  Baseline and 3 months

Secondary Outcomes (5)

• Angle of Trunk Rotation

  Baseline and 3 months

• Apical Vertebral Rotation

  Baseline and 3 months

• Pelvic Parameters

  Baseline and 3 months

• Pelvic Floor Muscle Activity

  Baseline and 3 months

• Sagittal Spinal Alignment Parameters

  Baseline and 3 months

Other Outcomes (2)

• Trunk Appearance Perception (TAPS) Scale

  Baseline and 3 months

• Trunk Aesthetic Clinical Evaluation (TRACE) Score

  Baseline and 3 months

Study Arms (2)

Scoliosis-Specific Three-Dimensional Exercise

ACTIVE COMPARATOR

Participants received supervised scoliosis-specific three-dimensional exercises for 3 months according to the study protocol.

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.

Behavioral: Scoliosis-Specific Three-Dimensional Exercise; Behavioral: Pelvic Floor Muscle Training

Interventions

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.

Scoliosis-Specific Three-Dimensional Exercise; Scoliosis-Specific Three-Dimensional Exercise + Pelvic Floor Muscle Training

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.

Scoliosis-Specific Three-Dimensional Exercise + Pelvic Floor Muscle Training

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead
• Gazi University Scientific Research Unit: collaborator

Study Sites (1)

Gaziosmanpasa Education and Research Hospital

Istanbul, Gaziosmanpasa, 34255, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Selda Başar, PhD

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to participants' group allocation throughout the study to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: May 12, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)