NCT07261358

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Start

First participant enrolled

October 6, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 11, 2026

Status Verified

October 1, 2025

Enrollment Period

6 months

First QC Date

November 22, 2025

Last Update Submit

February 8, 2026

Conditions

Keywords

postural kyphosissleep qualitytrunk muscle enduranceadolescent spine deformity

Outcome Measures

Primary Outcomes (2)

  • 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.

    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)

    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 Outcomes (5)

  • Thoracic Kyphosis Angle (Inclinometer Measurement)

    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)

    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)

    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

    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

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

Study Arms (2)

Three-Dimensional Exercise Group

EXPERIMENTAL

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.

Diagnostic Test: Kyphosis Study FormDiagnostic Test: Scoliosis X-ray (Orthoroentgenogram)Diagnostic Test: Inclinometer MeasurementDiagnostic Test: Biering-Sorensen Test (Back Extensor Endurance Test)

Control Group

OTHER

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.

Diagnostic Test: Kyphosis Study FormDiagnostic Test: Scoliosis X-ray (Orthoroentgenogram)Diagnostic Test: Inclinometer MeasurementDiagnostic Test: Biering-Sorensen Test (Back Extensor Endurance Test)

Interventions

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.

Control GroupThree-Dimensional Exercise Group

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.

Control GroupThree-Dimensional Exercise Group
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.

Control GroupThree-Dimensional Exercise Group

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.

Control GroupThree-Dimensional Exercise Group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazisomanpasa Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26413145BACKGROUND

MeSH Terms

Conditions

KyphosisSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Ebru Yılmaz Yalçınkaya, MD,Professor

    Gaziosmanpaşa Training and Research Hospital Physical Rehabilitation Department

    STUDY DIRECTOR

Central Study Contacts

Öznur Molla Kocabaş, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2025

First Posted

December 3, 2025

Study Start

October 6, 2025

Primary Completion

March 29, 2026

Study Completion

May 1, 2026

Last Updated

February 11, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations