NCT07482748

Brief Summary

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that can affect posture, trunk movement, and respiratory function. Changes in the shape of the rib cage may influence diaphragm function and breathing mechanics in individuals with scoliosis. The Schroth Best Practice (SBP) exercise program is commonly used in the conservative treatment of scoliosis and focuses on posture correction and scoliosis-specific exercises. However, the additional benefits of manual diaphragm mobilization combined with this exercise program are not well known. The aim of this randomized controlled trial is to investigate the effect of diaphragm mobilization added to the Schroth Best Practice program in adolescents with idiopathic scoliosis. Participants will be randomly assigned to two groups: one group will perform the SBP exercise program alone, and the other group will receive SBP exercises combined with diaphragm mobilization. The intervention will be performed three times per week for six weeks. Assessments will be conducted at baseline, at the end of the 6-week intervention, and at a 12-week follow-up. Outcomes will include respiratory function measured by spirometry, trunk rotation, thoracic mobility, trunk flexibility, quality of life, and body image. The results of this study may help determine whether adding diaphragm mobilization to scoliosis-specific exercise programs improves clinical outcomes in adolescents with idiopathic scoliosis.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Mar 2026Jan 2027

First Submitted

Initial submission to the registry

March 6, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 6, 2026

Last Update Submit

March 16, 2026

Conditions

Keywords

Adolescent Idiopathic ScoliosisDiaphragm MobilizationScoliosis-Specific ExerciseRespiratory FunctionPhysiotherapy

Outcome Measures

Primary Outcomes (4)

  • Forced Vital Capacity

    Forced vital capacity (FVC), expressed in liters, will be measured by spirometry to assess pulmonary function.

    Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)

  • Forced Expiratory Volume in One Second

    Forced expiratory volume in one second (FEV1), expressed in liters, will be measured by spirometry to assess pulmonary function.

    Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)

  • FEV1/FVC Ratio

    The FEV1/FVC ratio, expressed as a percentage, will be calculated from spirometry measurements to assess pulmonary function.

    Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)

  • Peak Expiratory Flow

    Peak expiratory flow (PEF), expressed in liters per minute, will be measured by spirometry to assess pulmonary function.

    Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)

Secondary Outcomes (5)

  • Trunk rotation angle measured by scoliometer

    Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)

  • Thoracic mobility measured by thoracic circumference difference

    Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)

  • Trunk lateral flexion flexibility

    Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)

  • Quality of life measured by Scoliosis Research Society-22 questionnaire

    Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)

  • Body image measured by Walter Reed Visual Assessment Scale

    Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)

Study Arms (2)

Schroth Best Practice Program + Diaphragm Mobilization

EXPERIMENTAL

Participants in this group will receive the Schroth Best Practice exercise program combined with diaphragm mobilization. The intervention will be performed three times per week for six weeks.

Procedure: Diaphragm MobilizationBehavioral: Schroth Best Practice Exercise Program

Schroth Best Practice Program

ACTIVE COMPARATOR

Participants in this group will receive the Schroth Best Practice exercise program three times per week for six weeks.

Behavioral: Schroth Best Practice Exercise Program

Interventions

Manual diaphragm mobilization will be performed with the participant in the supine position. The therapist will place both hands along the inferior costal margin and apply a gentle mobilization in coordination with the participant's breathing cycle. During inspiration and expiration, the inferior costal margin will be mobilized in a cranial and lateral direction. The technique will be performed for 20 breathing cycles and repeated twice during each treatment session with short rest periods between repetitions. The intervention will be applied at the end of each treatment session throughout the 6-week treatment period.

Also known as: Manual Diaphragm Release, Diaphragmatic Mobilization
Schroth Best Practice Program + Diaphragm Mobilization

The Schroth Best Practice (SBP) program is a physiotherapeutic scoliosis-specific exercise approach that includes curve-specific corrective exercises and postural education. Participants will perform exercises tailored to their scoliosis curve pattern under the supervision of a physiotherapist. The program will be applied three times per week for six weeks.

Also known as: Schroth Exercises
Schroth Best Practice ProgramSchroth Best Practice Program + Diaphragm Mobilization

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents aged between 10 and 18 years
  • Diagnosis of adolescent idiopathic scoliosis
  • Cobb angle ≥ 10°
  • Ability to participate in exercise sessions
  • Written informed consent from the participant and their parent or legal guardian

You may not qualify if:

  • Non-idiopathic scoliosis (e.g., neuromuscular, congenital, or syndromic scoliosis)
  • Presence of congenital anomalies affecting the musculoskeletal system
  • Previous scoliosis treatment within the last 6 months
  • Participation in another physiotherapy or rehabilitation program during the study period
  • Current use of a scoliosis brace
  • History of spinal surgery
  • Presence of neurological, rheumatological, or cardiopulmonary diseases that may affect participation in the intervention
  • Cognitive impairment, communication disorders, or any condition that may limit the ability to follow instructions or complete assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tuğba KURU ÇOLAK, PT, PhD

    Marmara University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eray Yüceel, PT, MSc(c)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessments will be performed by a physiotherapist who is blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly allocated into two parallel groups: (1) Schroth Best Practice exercise program and (2) Schroth Best Practice exercise program combined with diaphragm mobilization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 19, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share