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Supervised vs. Home Schroth Exercise in AIS

31. august 2026 opdateret af: Mesut Arslan, Bitlis Eren University

Comparative Effectiveness of Supervised vs. Home-Based Schroth Exercises in Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial

This study aims to compare the effectiveness of supervised Schroth exercises versus a home-based exercise program in adolescents with Adolescent Idiopathic Scoliosis (AIS).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional spinal deformity that develops in children aged 10-18, affecting approximately 0.47% to 12% of this population. If left untreated, curves between 10° and 45° may progress, leading to pain, breathing difficulties, postural problems, and reduced quality of life. Although bracing and surgery are traditional options, they have limitations. Physiotherapeutic scoliosis-specific exercises (PSSE), particularly the Schroth method, are increasingly recommended as a first-line conservative treatment.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

62

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Istanbul
      • Siliviri, Istanbul, Tyrkiet (Türkiye), 34570
        • Rekruttering
        • Silivri Devlet Hastanesi, Fizik Tedavi Ünitesi
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Diagnosis of Adolescent Idiopathic Scoliosis (idiopathic etiology)
  • Age between 10 and 18 years
  • Cobb angle between 10° and 45°
  • Able to participate in a 5-day/week exercise program (supervised or home-based)
  • Patient and parent/guardian provide written informed consent
  • Sufficient cooperation to comply with the study protocol and complete assessments

Exclusion Criteria:

  • Non-idiopathic scoliosis (neuromuscular, congenital, functional, etc.)
  • Prior or planned spinal surgery
  • Neurological, rheumatological, metabolic, or cardiopulmonary disease that would interfere with participation
  • Brace treatment within the last 6 months or planned during the study
  • Regular scoliosis-specific exercise (more than 2 days/week) within the last 6 months

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Supervised Schroth Exercise Group (SSEG)
Participants in this group will receive the exercise program under direct, one-on-one supervision by a physiotherapist. This is a purely physical exercise intervention. No drugs or devices are used as part of the intervention. Only the Schroth exercise program is administered.
Andet: Supervised Schroth Exercise
60-minute Schroth exercise sessions, 5 days/week for 12 weeks, delivered under one-on-one physiotherapist supervision. Includes 3D auto-correction, rotational breathing, postural stabilization, and curve-specific exercises (shoulder counter-pull, muscle cylinder, side-lying, sailing, prominent hip, Schroth walking)
Aktiv komparator: Home Exercise Program Group (HEPG)
Participants in this group will be provided with an individualized home exercise program that matches the supervised group in terms of principles, content, and duration. This is a purely physical exercise intervention. No drugs or devices are used as part of the intervention. Only the Schroth exercise program is administered.
Andet: Home-Based Schroth Exercise
Same 60-minute Schroth exercise program, 5 days/week for 12 weeks, performed at home without direct physiotherapist supervision. Participants receive initial instruction and an individualized exercise booklet.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Cobb Angle
Tidsramme: Baseline and 3 months post-intervention
Change in the primary curve Cobb angle measured on standing posteroanterior full-spine radiographs, assessed at baseline and 3 months post-intervention.
Baseline and 3 months post-intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Trunk Rotation Angle (ATR)
Tidsramme: Baseline and 12 weeks
Change in angle of trunk rotation measured using a scoliometer during the Adam's Forward Bend Test.
Baseline and 12 weeks
Change in Thoracic Kyphosis
Tidsramme: Baseline and 12 weeks
Change in thoracic kyphosis angle measured using an inclinometer at T1-T2 and T12-L1 levels.
Baseline and 12 weeks
Change in Lumbar Lordosis
Tidsramme: Baseline and 12 weeks
Change in lumbar lordosis angle measured using an inclinometer at T12-L1 and S2-S3 levels.
Baseline and 12 weeks
Respiratory Function assessed by Spirometry (FVC, FEV1, FEV1/FVC, PEF, FEF25-75%)
Tidsramme: Baseline and 12 weeks
Respiratory function will be assessed using a spirometry device. The following parameters will be recorded and analyzed: Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), the FEV1/FVC ratio, Peak Expiratory Flow (PEF), and Forced Expiratory Flow at 25-75% of FVC (FEF25-75%).
Baseline and 12 weeks
Change in Pain Level
Tidsramme: Baseline and 12 weeks
Change in musculoskeletal pain/discomfort assessed using the Turkish-validated Cornell Musculoskeletal Discomfort Questionnaire (T-CMDQ) [19]. The questionnaire evaluates discomfort in 18 body regions over the past week across three dimensions: frequency, severity, and functional impact on daily activities. A risk score is calculated for each body region by multiplying these three parameters. For bilaterally assessed regions, the higher of the two side-specific scores is used in the analysis. Higher scores indicate worse outcomes.
Baseline and 12 weeks
Change in Quality of Life
Tidsramme: Baseline and 12 weeks
Change in health-related quality of life assessed using the Turkish-validated Scoliosis Research Society-22 (SRS-22) questionnaire. The questionnaire consists of five domains: function, pain, self-image, mental health, and treatment satisfaction. Each item is scored from 1 (worst) to 5 (best); domain and total scores range from 1 to 5. Higher scores indicate better outcomes. The treatment satisfaction domain will be assessed only at 12 weeks; other domains assessed at both baseline and 12 weeks.
Baseline and 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bitlis Eren University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. august 2026

Primær færdiggørelse (Anslået)

31. august 2027

Studieafslutning (Anslået)

31. august 2027

Datoer for studieregistrering

Først indsendt

15. august 2026

Først indsendt, der opfyldte QC-kriterier

20. august 2026

Først opslået (Faktiske)

21. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • E.9290

Plan for individuelle deltagerdata (IPD)

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