- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07261358
The Effect of Three-Dimensional Exercises ( Schroth Method ) on Trunk Muscle Endurance, Sleep Quality, and Quality of Life in Adolescents With Hyperkyphosis
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Öznur Molla Kocabaş, MD
- Phone Number: +905388837799
- Email: oznurmolla@gmail.com
Study Contact Backup
- Name: Deniz Öke, MD
- Phone Number: +905324306950
- Email: dr_denizoke@hotmail.com
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Recruiting
- Gazisomanpasa Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Three-Dimensional Exercise Group
Adolescents 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. |
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.
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.
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.
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. |
|
Other: Control Group
Adolescents 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.
|
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.
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.
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.
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 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.
|
Assessments will be performed at baseline (one day before the exercise program ), at 1 month and at 3 months after the initiation of exercises.
|
|
Thoracic Kyphosis Angle (Inclinometer Measurement)
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.
|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thoracic Kyphosis Angle (Inclinometer Measurement)
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.
|
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.
|
Assessments will be performed at baseline (one day before the exercise program), at 1 month and at 3 months after the initiation of exercises.
|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Assessments will be performed at baseline (one day before the exercise programme ), at 1 month and at 3 months after the initiation of exercises.
|
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.
|
Assessments will be performed at baseline (one day before the exercise programme ), at 1 month and at 3 months after the initiation of exercises.
|
|
Adolescent Insomnia Questionnaire (AIQ)
Time Frame: Assessments will be performed at baseline (one day before the exercise programme ), at 1 month and at 3 months after the initiation of exercises.
|
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.
|
Assessments will be performed at baseline (one day before the exercise programme ), at 1 month and at 3 months after the initiation of exercises.
|
|
Visual Analog Scale
Time Frame: Assessments will be performed at baseline (one day before the exercise programme ), at 1 month and at 3 months after the initiation of exercises.
|
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.
|
Assessments will be performed at baseline (one day before the exercise programme ), at 1 month and at 3 months after the initiation of exercises.
|
|
Scoliosis Research Society-22 Questionnaire
Time Frame: Assessments will be performed at baseline (one day before the exercise programme ), at 1 month and at 3 months after the initiation of exercises.
|
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.
|
Assessments will be performed at baseline (one day before the exercise programme ), at 1 month and at 3 months after the initiation of exercises.
|
Collaborators and Investigators
Investigators
- Study Director: Ebru Yılmaz Yalçınkaya, MD,Professor, Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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