NCT07683533

Brief Summary

Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine that emerges during growth and is characterized by lateral curvature, vertebral rotation, and trunk asymmetry. AIS can negatively affect not only the spinal structure but also postural control, trunk stability, muscle activation patterns, respiratory function, and the quality of life of individuals. Particularly in thoracic curvatures, decreased rib cage mobility and impaired functional effectiveness of the diaphragm and intercostal muscles can lead to reduced respiratory capacity and respiratory muscle strength. Therefore, in scoliosis rehabilitation, it is important to evaluate not only spinal alignment but also respiratory mechanics and diaphragmatic function. Currently, among conservative treatment approaches, Three-Dimensional Scoliosis Exercises (Schroth method) are widely used and reported to be effective in reducing curvature progression. However, scientific evidence regarding the effects of supporting Schroth exercises with diaphragmatic manual techniques on muscle activation, trunk derotation, and respiratory function is limited. Since the diaphragm is both a primary respiratory muscle and an important postural muscle involved in spinal stabilization, it is thought that improving diaphragmatic function may contribute to scoliosis rehabilitation. In this randomized controlled trial, 24 individuals aged 10-18 years diagnosed with AIS will be divided into two groups. The study group will receive Schroth exercises supported by diaphragmatic manual techniques, while the control group will receive only Schroth exercises. Participants will be evaluated before and after treatment in terms of superficial muscle activity, Cobb angle, trunk rotation angle, perception of cosmetic deformity, respiratory functions, respiratory muscle strength, and quality of life. The unique value of this research is that it is one of the limited number of studies that multidimensionally examine the effects of diaphragmatic manual techniques combined with Schroth exercises on electromyographic muscle activation, derotation, and respiratory functions. It is expected that the results will contribute to the development of new rehabilitation approaches in the conservative treatment of AIS, strengthen evidence-based physiotherapy practices, and improve the quality of life of individuals with scoliosis.

Trial Health

63
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Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

July 6, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

June 23, 2026

Last Update Submit

July 1, 2026

Conditions

Keywords

Adolescent Idiopathic ScoliosisDiaphragmatic Manual TechniquesTrunk RotationMuscle ActivationSchroth ExercisesRespiratory Function

Outcome Measures

Primary Outcomes (8)

  • Change of Ossification of the Iliac Apophysis

    Evaluation of skeletal maturation is necessary to determine the patient's risk of progression. Risser grading is one of the most commonly used methods for measuring ossification of the iliac apophysis. Stage 0: No ossification Stage 1: Ossification of up to 25% of the iliac apophysis Stage 2: Ossification of 25% to 50% of the iliac apophysis Stage 3: Ossification of 50% to 75% of the iliac apophysis Stage 4: Ossification of more than 75% of the iliac apophysis Stage 5: Complete bone fusion of the iliac apophysis Growth is not considered complete until Stage 5 is reached; therefore, one of the inclusion criteria for the study is a maximum Risser stage of 4.

    Changes from baseline Ossification of the Iliac Apophysis at 12 weeks.

  • Change of Severity of Scoliosis

    The Cobb angle is an angle method that radiologically measures the degree of curvature. This angle is based on the angle between the top and bottom edges of the spinal segments at the beginning and end of the curvature. On the X-ray, the top and bottom vertebrae that form the spinal curve are selected. These vertebrae represent the beginning and ending points of the curvature. The top and bottom edges of each selected vertebra are drawn with lines, and an angle is measured through the intersection of these lines. This angle is considered the Cobb angle. Scoliosis can be diagnosed when the curvature in the spine is more than 10 degrees. If the Cobb angle is 10 degrees or more, this curvature is considered scoliosis.

    Change from baseline severity of scoliosis at 12 weeks.

  • Change of Trunk Rotation Angle

    Trunk rotation angle (ATR) will be measured using a Bunnell scoliometer. Frequently used to assess scoliosis progression and treatment effectiveness, the Bunnell scoliometer is an inclinometer known for its ease of use, low cost, and reliability. Measurements are taken by placing the scoliometer vertically along the axial axis of the vertebral column, perpendicular to the spinous processes of the vertebrae. In our study, assessments with the scoliometer will be performed in a standing forward-bend position. Patients will be asked to bend forward until the trunk is in a horizontal position and the scapula and pelvis are aligned. Care will be taken to ensure that the patients' arms are relaxed in this position. The highest rotation angle value obtained from the thoracic, thoracolumbar, and lumbar regions of the spine will be noted.

    Change from baseline trunk rotation angle at 12 weeks.

  • Change of Cosmetic Deformity Perception

    Patients' perception of cosmetic deformity will be assessed using the WRVAS (Walter Reed Visual Assessment Scale). WRVAS is a visual scale designed for patients with idiopathic scoliosis to describe how they perceive their own deformity. The scale categorizes deformity into 7 different aspects. Each of the 7 items includes a set of 5 figures representing the severity of the deformity. These sets contain visuals that assess spinal deformity, rib protrusion, lumbar protrusion, chest deformity, trunk imbalance, shoulder asymmetry, and scapular asymmetry. The visuals include posterior views of the deformity and assess how the patient feels about how others see their own back. Selected visuals are scored from a minimum of "1" to a maximum of "5". The results are used to understand the visual changes caused by scoliosis, as well as to monitor treatment outcomes. Reliability and validity studies were conducted on the Turkish version of the scale

    Changes from baseline Cosmetic Deformity Perception at 12 weeks.

  • Change of Quality of Life

    The Scoliosis Research Society-22 (SRS-22) questionnaire is a widely used self-report scale developed to assess quality of life in individuals with adolescent idiopathic scoliosis and adult spinal deformities for clinical and research purposes. Originally derived from the SRS-24 version, this form has been simplified to shorten assessment time and reduce patient burden. Today, it is used as a standardized tool to understand how scoliosis affects an individual's daily life. Each item is evaluated using a Likert-type response scale scored from 1 (worst case) to 5 (best case). Higher scores indicate better quality of life. For example, a question such as "To what extent does your back pain affect your daily activities?" quantitatively reflects the impact of the pain experienced by the individual on daily functioning. In the overall scoring of the questionnaire, excluding the treatment satisfaction dimension, average sub-dimension scores are obtained out of 20 items.

    Change from Baseline Quality of Life at 12 weeks.

  • Change of Electromyographic Activity of Muscles

    Muscles produce myoelectric potentials during contraction. Electromyography (EMG) is an evaluation method to determine the magnitude of this electrical activity of the muscle. Surface EMG signals are obtained with surface electrodes placed on the muscle body. High-magnitude EMG signals indicate that numerous motor units are firing. The magnitude of EMG signals provides information about how well the person can use the muscles being evaluated and the strength of the relevant muscle. Individuals with adolescent idiopathic scoliosis have asymmetric use and loss of strength in muscles. The main goal of the exercises used in treatment is to increase muscle strength, reduce asymmetric use, and increase the usability of the muscles. Evaluations will be performed with the wireless BTS FreeEMG-1000 system (BTS Engineering Corp.) electromyography device. The system has a miniaturized wireless surface EMG probe with Snap-On active electrodes that receive and transmit the signal in real time, and

    Change from Baseline Electromyographic Activities of Muscles at 12 weeks.

  • Change of Pulmonary Function

    Description: The Pulmonary Function Test will be performed with the COSMED Pony FX (COSMED; Italy) spirometer in accordance with the criteria of the American Thoracic Society (ATS) and the European Respiratory Society (ERS). Forced vital capacity (FVC), Forced expiratory volume in 1 second (FEV1), Tiffeneau ratio (FEV1/FVC), Forced expiratory flow 25-75% (FEF25-75%) and peak expiratory flow rate (PEF) values and predictive values percentage will be recorded. Preoperative period, postoperative 7th day, postoperative 4th week and postoperative 8th week will be repeated.

    Change from Baseline Pulmonary Function at 8 weeks.

  • Change of Respiratory Muscle Strength

    Respiratory muscle strength measurement will be performed with a portable, electronic intraoral pressure measuring device COSMED Pony FX (COSMED; Italy) according to ATS/ERS criteria. The MIP will be measured at residual volume and during deep inspiration. MEP will be determined at total lung capacity and during deep expiration. Measurements will be made in a sitting position using a nose clip. Patients will be verbally encouraged for the best strength. Measurement will be made until it provides the valid value in patients. Preoperative period, postoperative 7th day, postoperative 4th week and postoperative 8th week will be repeated.

    Change from Baseline Respiratory Muscle Strength at 12 weeks.

Secondary Outcomes (3)

  • Height in Meters

    Initial assessment before surgery

  • Weight in Kilograms

    Initial assessment before surgery

  • Body Mass Index (BMI) in kg/m^2

    Initial assessment before surgery

Study Arms (2)

Diaphragmatic manual techniques and Schroth exercises

EXPERIMENTAL

The Diaphragmatic manual techniques and Schroth exercises group will receive 15 minutes of diaphragmatic manual techniques followed by 45 minutes of Schroth exercises.

Other: Diaphragmatic manual techniquesOther: Schroth exercises

Schroth exercises

ACTIVE COMPARATOR

Patients in the Schroth exercises group will only perform Schroth exercises for 60 minutes.

Other: Schroth exercises

Interventions

With the patient sitting upright, the physiotherapist will position themselves behind the patient, placing their hands across the rib cage and fingertips to the subcostal margins. As the patient exhales, the physiotherapist will apply gentle but firm lateral pulling force from the subcostal margin to stretch the diaphragm. This pulling will be continued during inhalation. After repeating this for several breathing cycles, the patient will be placed supine, with hands bilaterally placed on the lower ribs, and mobilization will be performed in a figure-eight pattern. For diaphragm mobilization, individuals will lie comfortably on their backs. The physiotherapist, positioned above the individual's head, will place the hypothenar region and the last three fingers of their hands bilaterally on the 7th-10th costal cartilages. The therapist will apply lateral and longitudinal pulls with their hands to support rib elevation during inspiration.

Diaphragmatic manual techniques and Schroth exercises

During a Schroth exercise session, the goal is to stabilize proper posture by lengthening shortened muscles and activating stretched muscles through rotational breathing, based on the principles of active elongation, deflection, and derotation postural correction. Individuals will be positioned in three different positions-sleeping, sitting, and standing-with passive or active support, and stabilization will be achieved through isometric stretching. Each position will be held for 10 breaths\*3 sets, and the therapist will monitor the corrections throughout the session.

Diaphragmatic manual techniques and Schroth exercisesSchroth exercises

Eligibility Criteria

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

You may qualify if:

  • Individuals aged 10-18 years, in adolescence.
  • Scoliosis curvature in the thoracic region.
  • Individuals and their parents (those who have signed the informed consent form) who agree to participate in regular follow-up and exercise programs throughout the study period.
  • Diagnosis of AIS by a physician.
  • Patients with idiopathic scoliosis diagnosed radiologically and with a Cobb angle less than 30°.
  • The child and family agree to participate in and adhere to the 12-week treatment process.
  • Ability to understand and speak Turkish.
  • Not being in another treatment program. Individuals without any systemic disease that prevents participation in the physical exercise program.

You may not qualify if:

  • Individuals who report that they cannot participate regularly during the exercise period or who will not adhere to the study schedule.
  • Individuals who have not previously undergone surgery for scoliosis
  • Those with accompanying neuromuscular or rheumatic diseases
  • Those receiving other scoliosis-related treatment during the study
  • Malignancy
  • Those using braces
  • Individuals with cognitive impairment that prevents them from understanding and performing the exercises mentally or physically.
  • Those with respiratory and cardiovascular system diseases requiring regular medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Neriman Temel Aksu

    Akdeniz University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Açelya Kocabey

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 23, 2026

First Posted

July 6, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

July 6, 2026

Record last verified: 2026-07

Locations