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Spine DeformityNCT07261358

The Effect of Three-Dimensional Exercises ( Schroth Method ) on Trunk Muscle Endurance, Sleep Quality, and Quality of Life in Adolescents With Hyperkyphosis

A study testing Kyphosis Study Form, Scoliosis X-ray (Orthoroentgenogram) and Inclinometer Measurement in people with Spine Deformity and Kyphosis, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Adolescence is a critical period for spinal growth, and progression of thoracic hyperkyphosis may lead to pain, weak trunk muscles, sleep disturbances, and reduced quality of life. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Spine Deformity, Kyphosis, Adolescent
What is being tested?
Kyphosis Study Form, Scoliosis X-ray (Orthoroentgenogram) and Inclinometer Measurement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Oct 2025to 1 May 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 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Adolescents between 12 and 18 years of age
  • Presence of thoracic kyphosis with a T3-T12 Cobb angle ≥45° measured on a lateral thoracic radiograph
  • Sufficient physical and cognitive ability to actively participate in the exercise protocol for at least 3 months
  • Adequate communication and cognitive capacity to understand the educational materials provided
  • Ability and willingness to regularly complete the exercise log throughout the study period

Who cannot join

  • Scoliosis with a Cobb angle >10° in the coronal plane
  • Presence of structural spinal deformities such as vertebral fracture, spondylolisthesis
  • History of previous spinal surgery
  • Neuromuscular disorders that may affect the spine (e.g., cerebral palsy, muscular dystrophy)
  • Structural or functional pathologies involving the spine, pelvic complex, or shoulder girdle
  • Balance disorders such as vestibular dysfunction, vertigo, or other conditions affecting postural control
Show all 9Show fewer
  • Inability to comply with the exercise protocol due to intellectual disability, severe behavioral disorders, or significant communication impairments
  • Participation in professional-level sports activities that may influence exercise capacity or musculoskeletal function
  • Presence of serious cardiopulmonary diseases (e.g., congenital heart disease, pulmonary hypertension)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Öznur Molla Kocabaş, MD contact

+905388837799

oznurmolla@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Gazisomanpasa Training and Research Hospital

    Istanbul

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Adolescence is a critical period for spinal growth, and progression of thoracic hyperkyphosis may lead to pain, weak trunk muscles, sleep disturbances, and reduced quality of life. This study aims to investigate the effects of three-dimensional exercise program based on the Schroth Method on trunk muscle endurance, thoracic kyphosis angle, pain, sleep quality and quality of life in adolescents aged 12-18 years with hyperkyphosis.

Read the detailed description

Childhood and adolescence are critical developmental stages characterized by rapid spinal growth, as well as the formation of postural habits and the musculoskeletal system. During this process, various spinal deformities may arise due to neuromuscular, structural, postural, or functional causes, and if not addressed in a timely manner, they can lead to permanent postural abnormalities carried into adulthood.

Thoracic kyphosis is the physiologically present forward curvature of the spine in the sagittal plane and is generally considered normal within the range of 20°-45°. However, when this angle exceeds 45°, it is referred to as hyperkyphosis. Hyperkyphosis can develop due to many different causes, such as postural abnormalities, muscle imbalances, and vertebral developmental anomalies. This deformity can become more pronounced, especially during adolescence when growth spurts occur.

The progression of hyperkyphosis that emerges during the developmental period can lead to serious clinical consequences in children and adolescents, including aesthetic concerns, weak trunk muscles, pain around the spine, sleep disorders, and a decline in quality of life. Timely diagnosis and effective rehabilitation of adolescent hyperkyphosis are critical in controlling the progression of the deformity and preventing functional loss.

The literature reports that exercise-based approaches are effective in treating kyphosis in this age group. Schroth exercises, in particular, are a specialized physical therapy protocol used in the treatment of 3-dimensional scoliosis and kyphosis. They offer individualized, breathing-integrated postural correction techniques that target interplanar asymmetry of the spine. With this approach, patients are taught positioning to actively correct spinal segments, proprioceptive awareness, and breathing control. The Schroth method aims not only at passive posture correction but also at reestablishing muscle balance and maintaining correct posture in daily life.

In this context, Schroth exercises, which specifically target 3-dimensional spinal correction, are among the interventions frequently recommended in the literature.

The aim of this study is to evaluate the effect of Schroth exercises on back muscle endurance, thoracic kyphosis angle, pain, quality of life, and sleep in adolescents with hyperkyphosis.

Being tested
Kyphosis Study Form, Scoliosis X-ray (Orthoroentgenogram), Inclinometer Measurement, Biering-Sorensen Test (Back Extensor Endurance Test)
Keywords
postural kyphosis, sleep quality, trunk muscle endurance, adolescent spine deformity
Medical subject headings
Kyphosis, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kyphosis Study FormDiagnostic test

    Kyphosis study form consisting of clinical and radiological measurements of patients aged 12-18 years who applied to the outpatient clinic with spine deformity will be filled in detail.

  • Scoliosis X-ray (Orthoroentgenogram)Diagnostic test

    Adolescents aged 12-18 years presenting to the scoliosis outpatient clinic will undergo a standardized physical examination. Posture will be assessed in standing position from both anterior and lateral views in front of a posture chart. In patients where thoracic kyphosis is clinically suspected, a standing orthoroentgenogram (whole-spine radiograph) will be requested. On these radiographs, thoracic kyphosis angles will be measured to confirm the diagnosis and establish baseline values. Clinical and radiological data will be recorded in detail before study group allocation.

  • Inclinometer MeasurementDiagnostic test

    Thoracic kyphosis angle will also be assessed using a bubble inclinometer during physical examination. The participant will stand in a relaxed upright position, and the inclinometer will be placed over the spinous processes from T3 to T12 to measure the sagittal alignment of the thoracic spine. Three consecutive measurements will be taken for each participant, and the mean value will be recorded for analysis. This provides a reliable clinical estimate of thoracic kyphosis in addition to radiographic assessment.

  • Biering-Sorensen Test (Back Extensor Endurance Test)Diagnostic test

    The Biering-Sorensen test is a standardized clinical assessment used to evaluate the isometric endurance of the trunk extensor muscles. During the test, the participant lies prone on an examination table with the upper edge of the iliac crests aligned with the edge of the table. The lower body (pelvis, knees, and ankles) is stabilized using straps or manual fixation. The upper body is extended horizontally beyond the edge of the table, with the arms crossed over the chest. The participant is instructed to maintain the unsupported horizontal trunk position for as long as possible without assistance.

    The outcome is recorded as the duration, in seconds, that the participant can hold the trunk in a straight horizontal alignment before fatigue, deviation from the position, or voluntary termination occurs.

Study groups in NCT07261358
Study groupRoleWhat they receive
Three-Dimensional Exercise GroupExperimentalAdolescents aged 12 to 18 years with a diagnosis of kyphosis will undergo a supervised three-dimensional exercise program based on the Schroth Method. The intervention is specifically tailored for adolescents with kyphosis and aims to improve postural alignment, increase spinal mobility, enhance back extensor muscle endurance, and restore trunk muscle balance. The program consists of 10 outpatient sessions (approximately 60 minutes each), delivered by a physiotherapist trained in the Schroth Method. Exercises include postural correction, rotational angular breathing techniques, stabilization strategies, and individualized corrective postures adapted to the patient's spinal deformity pattern. After completing the supervised sessions, participants will be instructed to continue performing the Schroth exercises as a home-based program for the remainder of the study period, with adherence monitored through exercise logs and outpatient follow-up.
Receives: Diagnostic Test: Kyphosis Study Form; Diagnostic Test: Scoliosis X-ray (Orthoroentgenogram); Diagnostic Test: Inclinometer Measurement; Diagnostic Test: Biering-Sorensen Test (Back Extensor Endurance Test)
Control GroupOtherAdolescents aged 12 to 18 years with a diagnosis of kyphosis will be assigned to a home-based back extensor strengthening exercise program. Participants will receive detailed written and illustrated instructions on standardized back extensor strengthening exercises. After an initial instruction session, they will be asked to perform the exercises independently at home, every day per week, for the duration of the study period. Adherence will be monitored through exercise logs and outpatient follow-up visits.
Receives: Diagnostic Test: Kyphosis Study Form; Diagnostic Test: Scoliosis X-ray (Orthoroentgenogram); Diagnostic Test: Inclinometer Measurement; Diagnostic Test: Biering-Sorensen Test (Back Extensor Endurance Test)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biering-Sorensen Test (Back Extensor Endurance Test)

    The Biering-Sorensen test is a standardized clinical assessment used to evaluate the isometric endurance of the trunk extensor muscles. During the test, the participant lies prone on an examination table with the upper edge of the iliac crests aligned with the edge of the table. The lower body (pelvis, knees, and ankles) is stabilized using straps or manual fixation. The upper body is extended horizontally beyond the edge of the table, with the arms crossed over the chest. The participant is instructed to maintain the unsupported horizontal trunk position for as long as possible without assistance. The outcome is recorded as the duration, in seconds, that the participant can hold the trunk in a straight horizontal alignment before fatigue, deviation from the position, or voluntary termination occurs.

    Measured: Assessments will be performed at baseline (one day before the exercise program ), at 1 month and at 3 months after the initiation of exercises.

  2. Thoracic Kyphosis Angle (Inclinometer Measurement)

    Thoracic sagittal alignment will be assessed using a bubble inclinometer placed over the spinous processes from T3 to T12 while the participant stands in a relaxed upright position. Three consecutive measurements will be performed for each participant, and the mean value will be recorded for analysis. This clinical method provides a reliable and non-invasive estimate of thoracic kyphosis angle in adolescents.

    Measured: Assessments will be performed at baseline (one day before the exercise program), at 1 month and at 3 months after the initiation of exercises.

Secondary outcomes (5)
  1. Thoracic Kyphosis Angle (Inclinometer Measurement)

    Thoracic sagittal alignment will be assessed using a bubble inclinometer placed over the spinous processes from T3 to T12 while the participant stands in a relaxed upright position. Three consecutive measurements will be performed for each participant, and the mean value will be recorded for analysis. This clinical method provides a reliable and non-invasive estimate of thoracic kyphosis angle in adolescents.

    Measured: Assessments will be performed at baseline (one day before the exercise program), at 1 month and at 3 months after the initiation of exercises.

  2. Pittsburgh Sleep Quality Index (PSQI)

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated self-reported questionnaire that evaluates sleep quality and disturbances over the previous month. The PSQI consists of 19 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored on a scale of 0 to 3, yielding a total score ranging from 0 to 21, with higher scores indicating poorer sleep quality.

    Measured: Assessments will be performed at baseline (one day before the exercise programme ), at 1 month and at 3 months after the initiation of exercises.

  3. Adolescent Insomnia Questionnaire (AIQ)

    Insomnia symptoms will be assessed using the Adolescent Insomnia Questionnaire (AIQ), a validated self-reported instrument specifically developed for adolescents to evaluate insomnia severity and sleep difficulties. The AIQ consists of 13 items covering three main domains: difficulties initiating sleep, difficulties maintaining sleep, and early morning awakenings. Each item is rated on a 0-4 Likert scale, with higher scores indicating greater severity of insomnia symptoms. The AIQ has been shown to be reliable and valid for assessing insomnia in adolescents.

    Measured: Assessments will be performed at baseline (one day before the exercise programme ), at 1 month and at 3 months after the initiation of exercises.

  4. Visual Analog Scale

    Pain intensity will be assessed using the Visual Analog Scale (VAS) with facial expression illustrations. This tool consists of a series of facial expressions ranging from a smiling face indicating "no pain" (score 0) to a crying face indicating "worst pain" (score 10). Participants will be asked to select the face that best represents their current level of back pain. Scores will be recorded on a 0-10 scale, with higher scores reflecting greater pain severity.

    Measured: Assessments will be performed at baseline (one day before the exercise programme ), at 1 month and at 3 months after the initiation of exercises.

  5. Scoliosis Research Society-22 Questionnaire

    Health-related quality of life will be evaluated using the Scoliosis Research Society-22 (SRS-22) Questionnaire. The SRS-22 is a validated patient-reported outcome measure that consists of 22 items grouped into five domains: Function/Activity, Pain, Self-image/Appearance, Mental Health, and Satisfaction with Management. Each item is scored on a 5-point Likert scale, where higher scores indicate better health status and quality of life. Domain scores and the total score will be calculated.

    Measured: Assessments will be performed at baseline (one day before the exercise programme ), at 1 month and at 3 months after the initiation of exercises.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2025
  2. Study start6 Oct 2025
  3. Primary completion29 Mar 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

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
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07261358
Sponsor's protocol ID
1024
Status last verified
Oct 2025
First submitted
22 Nov 2025
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schreiber S, Parent EC, Moez EK, Hedden DM, Hill D, Moreau MJ, Lou E, Watkins EM, Southon SC. The effect of Schroth exercises added to the standard of care on the quality of life and muscle endurance in adolescents with idiopathic scoliosis-an assessor and statistician blinded randomized controlled trial: "SOSORT 2015 Award Winner". Scoliosis. 2015 Sep 18;10:24. doi: 10.1186/s13013-015-0048-5. eCollection 2015.

    PubMed 26413145

Questions about this trial

What is this clinical trial studying?

A study testing Kyphosis Study Form, Scoliosis X-ray (Orthoroentgenogram) and Inclinometer Measurement in people with Spine Deformity and Kyphosis, run by Gaziosmanpasa Research and Education Hospital 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 11 Feb 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?

Contact Öznur Molla Kocabaş, MD (+905388837799, oznurmolla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biering-Sorensen Test (Back Extensor Endurance Test) (time frame: Assessments will be performed at baseline (one day before the exercise program ), at 1 month and at 3 months after the initiation of exercises.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07261358, which also lists 1 linked publication.

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 11 Feb 2026.

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