NCT06907914

Brief Summary

This randomized controlled trial aims to investigate the effects of Schroth exercises on scapular muscle activation in children with thoracic hyperkyphosis. A total of 56 participants will be randomly assigned to either the Schroth exercise group or the control group receiving postural education. The intervention group will complete an 8-week supervised Schroth program focusing on three-dimensional correction, rotational breathing, and postural awareness. Primary outcome is scapular muscle activation measured by surface EMG. Secondary outcomes include muscle strength, scapular endurance, kyphotic appearance, posture, and pain. The results will guide clinical management and preventive strategies for children with postural thoracic hyperkyphosis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jun 2025

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 Progress79%
Jun 2025Aug 2026

First Submitted

Initial submission to the registry

March 26, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

October 1, 2025

Status Verified

April 1, 2025

Enrollment Period

11 months

First QC Date

March 26, 2025

Last Update Submit

September 25, 2025

Conditions

Keywords

SpineSchrothsEMGPhysiotehrapyScapulaThoracic Hyperkyphosis

Outcome Measures

Primary Outcomes (1)

  • Muscle Activation (sEMG)

    Surface electromyography (sEMG) will assess the activation of the upper, middle, lower trapezius, and serratus anterior muscles, following SENIAM protocols. Signals will be normalized to %MVC and analyzed for concentric, isometric, and eccentric phases using RMS methods with a 20 Hz high-pass filter.

    8 weeks

Secondary Outcomes (7)

  • Muscle Strength

    8 weeks

  • Scapular Muscle Endurance Test

    8 weeks

  • Kyphosis-Specific Spinal Appearance Questionnaire

    8 weeks

  • PostureScreen Mobile Application

    8 weeks

  • Postural Habits and Awareness Scale

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

Participants in the experimental group will undergo a supervised 3D Schroth-based exercise program with postural education. The intervention will be applied 3 times per week for 8 weeks, totaling 24 sessions, each lasting approximately 45 minutes, delivered in-person by a trained physiotherapist. Exercises will include corrective postural training, scapular stabilization, rotational breathing, and static stretching. The program is delivered in two progressive phases: Weeks 1-4: Postural awareness and basic muscle activation Weeks 5-8: Functional integration and advanced stabilization Progression criteria are based on repetitions: exercises begin at 9 reps × 3 sets, and progress to 15 reps × 3 sets. Static stretches start with 20 seconds × 2 sets and are increased to 3 sets before progressing. All exercises are individualized based on clinical assessment.

Other: Schroth

Group B

NO INTERVENTION

The control group will receive a single, standardized session of postural education at the beginning of the study, during which general information about correct posture, ergonomic principles, and spinal health will be provided. Following this session, participants in the control group will be placed on a waiting list and monitored for a period of 8 weeks. During this time, they will not receive any specific exercise intervention or additional therapeutic program related to posture or muscle strengthening. Regular follow-up will be conducted to ensure participant safety and to monitor any changes or adverse events throughout the waiting period.

Interventions

SchrothOTHER

The Schroth intervention consists of a structured, three-dimensional exercise program based on scoliosis-specific principles. It incorporates corrective postural alignment, rotational breathing techniques, and targeted activation of spinal and scapular stabilizing muscles. The exercises are designed to improve postural control, enhance muscle endurance, and promote neuromuscular re-education for better functional alignment during daily activities.

Group A

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Thoracic kyphosis angle (Cobb) between ≥40° and \<70° on lateral radiographs
  • Aged 7-18 years
  • Risser stage 0-5, indicating ongoing skeletal development

You may not qualify if:

  • Congenital or rigid spinal deformities/anomalies
  • Major musculoskeletal surgery or trauma, especially involving the spine
  • Physiotherapeutic intervention for the spine in the last 6 months
  • Current brace use
  • BMI ≥ 30
  • Regular upper extremity sports involvement (e.g., swimming, volleyball) at least twice a week for one year
  • More than 60 minutes of moderate-to-high intensity physical activity per week
  • Visual impairments or light sensitivity
  • Positive vestibular (Unterberger) test
  • Hearing impairments
  • Cognitive difficulties affecting comprehension
  • Systemic diseases (diabetes, hypothyroidism, infection, malignancy)
  • Neurological disorders
  • Active rheumatic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Scheuermann DiseaseCongenital Abnormalities

Condition Hierarchy (Ancestors)

Spinal OsteochondrosisOsteochondrosisBone DiseasesMusculoskeletal DiseasesKyphosisSpinal CurvaturesSpinal DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ayşe Zengin Alpözgen, Assoc Prof.

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kübra Kardeş, PhD

CONTACT

Turgut Akgül, Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This study will employ assessor and statistician blinding. The physiotherapists performing baseline and post-intervention assessments will be blinded to group allocation to minimize bias. Additionally, statistical analyses will be conducted by a researcher blinded to group assignments. Participants and therapists delivering the intervention will not be blinded due to the nature of the exercise-based intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups: the intervention group receiving Schroth exercises combined with postural education, and the control group receiving only postural education while placed on a waiting list. Both groups will be evaluated at baseline and after the 8-week intervention period
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

March 26, 2025

First Posted

April 2, 2025

Study Start

June 15, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

October 1, 2025

Record last verified: 2025-04

Locations