NCT07552662

Brief Summary

This randomized controlled trial evaluates the effectiveness of Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) compared with General Exercises in adolescents with idiopathic scoliosis over a 12-month intervention period. Primary outcomes include Cobb angle progression and brace prescription rate. Secondary outcomes include trunk rotation, quality of life, self-image, and body symmetry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

April 20, 2026

Last Update Submit

April 20, 2026

Conditions

Keywords

Scoliosis IdiopathicCobb anglequality of life

Outcome Measures

Primary Outcomes (2)

  • Change in Cobb Angle

    Cobb angle will be measured on standing anteroposterior spinal radiographs using the standard Cobb method. The angle is defined as the intersection of lines drawn parallel to the superior endplate of the upper-end vertebra and the inferior endplate of the lower-end vertebra of the primary curve. Measurements will be performed at baseline and after the intervention period, and the change in Cobb angle (in degrees) will be calculated. Lower values indicate an improvement in spinal curvature.

    Baseline to 12 Months

  • Brace Prescription Rate

    The proportion of participants requiring orthotic bracing during the study period will be recorded. Brace prescription will be determined by a specialist according to established clinical criteria (e.g., curve magnitude, skeletal maturity, and risk of progression). The rate will be expressed as the percentage of participants prescribed a brace in each group during the follow-up period.

    12 Months

Secondary Outcomes (3)

  • SRS-22 Questionnaire Score

    Baseline to 12 Months

  • TAPS Score

    Baseline to 12 Months

  • TRACE Score

    Baseline to 12 Months

Study Arms (2)

PSSE-Schroth Group

EXPERIMENTAL

Participants performed individualized PSSE-Schroth exercises based on curve pattern, including corrective breathing, postural correction, and ADL training.

Other: PSSE-Schroth Exercises

General Exercise Group

ACTIVE COMPARATOR

Participants performed general strengthening and stretching exercises without scoliosis-specific correction.

Other: General Exercises

Interventions

Participants performed individualized PSSE-Schroth exercises based on curve pattern, including corrective breathing, postural correction, and ADL training

PSSE-Schroth Group

Participants performed general strengthening and stretching exercises without scoliosis-specific correction.

General Exercise Group

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of adolescent idiopathic scoliosis
  • Cobb angle 10°-25°
  • Risser sign 0-3 ATR \>5°
  • Less than 1 year post-menarche (for females)

You may not qualify if:

  • Previous brace treatment \* Non-idiopathic scoliosis
  • Previous scoliosis surgery
  • Neuromuscular or congenital scoliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Şahinbey, 27000, Turkey (Türkiye)

Location

Related Publications (8)

  • Zhang Y, Chai T, Weng H, Liu Y. Pelvic rotation correction combined with Schroth exercises for pelvic and spinal deformities in mild adolescent idiopathic scoliosis: A randomized controlled trial. PLoS One. 2024 Jul 30;19(7):e0307955. doi: 10.1371/journal.pone.0307955. eCollection 2024.

  • Mohamed N, Acharya V, Schreiber S, Parent EC, Westover L. Effect of adding Schroth physiotherapeutic scoliosis specific exercises to standard care in adolescents with idiopathic scoliosis on posture assessed using surface topography: A secondary analysis of a Randomized Controlled Trial (RCT). PLoS One. 2024 Apr 30;19(4):e0302577. doi: 10.1371/journal.pone.0302577. eCollection 2024.

  • Kuru T, Yeldan I, Dereli EE, Ozdincler AR, Dikici F, Colak I. The efficacy of three-dimensional Schroth exercises in adolescent idiopathic scoliosis: a randomised controlled clinical trial. Clin Rehabil. 2016 Feb;30(2):181-90. doi: 10.1177/0269215515575745. Epub 2015 Mar 16.

  • Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.

  • Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19.

  • Bago J, Sanchez-Raya J, Perez-Grueso FJ, Climent JM. The Trunk Appearance Perception Scale (TAPS): a new tool to evaluate subjective impression of trunk deformity in patients with idiopathic scoliosis. Scoliosis. 2010 Mar 25;5:6. doi: 10.1186/1748-7161-5-6.

  • Asher M, Min Lai S, Burton D, Manna B. The reliability and concurrent validity of the scoliosis research society-22 patient questionnaire for idiopathic scoliosis. Spine (Phila Pa 1976). 2003 Jan 1;28(1):63-9. doi: 10.1097/00007632-200301010-00015.

  • Langensiepen S, Semler O, Sobottke R, Fricke O, Franklin J, Schonau E, Eysel P. Measuring procedures to determine the Cobb angle in idiopathic scoliosis: a systematic review. Eur Spine J. 2013 Nov;22(11):2360-71. doi: 10.1007/s00586-013-2693-9. Epub 2013 Feb 27.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors and statisticians were blinded to group allocation. Participants and treating therapists were not blinded due to the nature of exercise interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomized in a 1:1 ratio to either PSSE-Schroth or General Exercise intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 27, 2026

Study Start

April 18, 2024

Primary Completion

November 18, 2024

Study Completion

November 18, 2025

Last Updated

April 27, 2026

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations