Supervised vs. Home Schroth Exercise in AIS
31. august 2026 oppdatert av: 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).
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
62
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mesut Arslan, PhD
- Telefonnummer: +90 553 674 5226
- E-post: fzt.mesutarslan@gmail.com
Studiesteder
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Istanbul
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Siliviri, Istanbul, Tyrkia (Türkiye), 34570
- Rekruttering
- Silivri Devlet Hastanesi, Fizik Tedavi Ünitesi
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Ta kontakt med:
- Mehmet Emin Durbulu
- Telefonnummer: +90 506 146 4064
- E-post: fztmehmetdurbulu@gmail.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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)
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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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Cobb Angle
Tidsramme: Baseline and 3 months post-intervention
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Change in the primary curve Cobb angle measured on standing posteroanterior full-spine radiographs, assessed at baseline and 3 months post-intervention.
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Baseline and 3 months post-intervention
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Trunk Rotation Angle (ATR)
Tidsramme: Baseline and 12 weeks
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Change in angle of trunk rotation measured using a scoliometer during the Adam's Forward Bend Test.
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Baseline and 12 weeks
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Change in Thoracic Kyphosis
Tidsramme: Baseline and 12 weeks
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Change in thoracic kyphosis angle measured using an inclinometer at T1-T2 and T12-L1 levels.
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Baseline and 12 weeks
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Change in Lumbar Lordosis
Tidsramme: Baseline and 12 weeks
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Change in lumbar lordosis angle measured using an inclinometer at T12-L1 and S2-S3 levels.
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Baseline and 12 weeks
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Respiratory Function assessed by Spirometry (FVC, FEV1, FEV1/FVC, PEF, FEF25-75%)
Tidsramme: Baseline and 12 weeks
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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%).
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Baseline and 12 weeks
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Change in Pain Level
Tidsramme: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Change in Quality of Life
Tidsramme: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
31. august 2026
Primær fullføring (Antatt)
31. august 2027
Studiet fullført (Antatt)
31. august 2027
Datoer for studieregistrering
Først innsendt
15. august 2026
Først innsendt som oppfylte QC-kriteriene
20. august 2026
Først lagt ut (Faktiske)
21. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- E.9290
Plan for individuelle deltakerdata (IPD)
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NEI
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