Effect of a 16-Week Physiotherapeutic Corrective Exercise Program on Spinal Deformities in Adolescent Idiopathic Scoliosis (SPINE-AIS16)
The Effect of a 16-Week Structured Physiotherapeutic Corrective Exercise Program on Lateral Spinal Deviation, Vertebral Rotation, and Pelvic Position in Mild and Moderate Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial
Brief Summary
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that may progress during adolescence and lead to postural asymmetry, spinal rotation, pelvic imbalance, reduced spinal mobility, and decreased quality of life.
This randomized controlled trial aims to evaluate the effectiveness of a 16-week structured physiotherapeutic corrective exercise program compared with standard physiotherapy care in adolescents with mild to moderate AIS (Cobb angle 10°-40°).
Participants aged 10-18 years will be randomly assigned to either an experimental group or a control group using stratified block randomization based on age and baseline Cobb angle. The study will be conducted under the responsibility of the University of Prishtina- Faculty of Medicine and the University Clinical Center of Kosovo, with academic collaboration from Alma Mater Europaea.
The experimental group will receive a structured physiotherapeutic corrective exercise program including core stabilization, stretching, spinal self-correction, and pelvic correction exercises. The control group will receive standard physiotherapy exercises used in routine clinical practice.
Both groups will undergo supervised physiotherapy sessions three times per week for 16 weeks, with additional prescribed home exercises.
Primary outcomes include individual spinal alignment parameters assessed using the DIERS Formetric 3D/4D system, including lateral deviation angle and vertebral rotation. Secondary outcomes include additional postural alignment parameters, spinal mobility measured using an inclinometer, and health-related quality of life assessed using the Scoliosis Research Society-22 Revised (SRS-22r) questionnaire.
Assessments will be performed at baseline, 8 weeks, and 16 weeks. Each outcome parameter will be analyzed separately to evaluate changes over time and differences between groups.
The study will provide evidence on whether a structured corrective physiotherapy program offers superior outcomes compared with standard physiotherapy care in adolescents with AIS.
調査の概要
状態
詳細な説明
Detailed Description
This randomized controlled trial evaluates the effectiveness of a structured physiotherapeutic corrective exercise program in adolescents with mild to moderate idiopathic scoliosis (Cobb angle 10°-40°), compared with standard physiotherapy care.
Adolescent idiopathic scoliosis is a structural spinal deformity characterized by lateral curvature, vertebral rotation, and postural imbalance. It may also be associated with pelvic asymmetry, altered sagittal spinal alignment, reduced spinal mobility, and impaired health-related quality of life.
Despite evidence supporting physiotherapeutic scoliosis-specific exercises, limited research has investigated comprehensive exercise programs addressing spinal alignment, postural control, and pelvic-related impairments simultaneously using advanced three-dimensional postural assessment systems.
Participants aged 10-18 years will be recruited from the Physical Medicine and Rehabilitation Clinic at the University Clinical Center of Kosovo and the University of Prishtina - Faculty of Medicine. The study is conducted under ethical approval from relevant institutional ethics committees. Alma Mater Europaea serves as an academic collaborating institution.
Participants will be randomly allocated to an experimental or control group using stratified block randomization based on age and baseline Cobb angle. Outcome assessors and statisticians will be blinded to group allocation.
The experimental group will follow a 16-week structured physiotherapeutic corrective exercise program including core stabilization, stretching, spinal self-correction, and pelvic correction exercises. The control group will receive standard physiotherapy exercises commonly used in clinical practice for adolescent idiopathic scoliosis.
Both groups will receive supervised physiotherapy sessions three times per week for 16 weeks, each lasting approximately 45 minutes, and will perform additional home-based exercises two days per week.
Primary outcome measures will include individual spinal alignment parameters assessed using the DIERS Formetric 3D/4D Spine & Posture Analysis System, including change in lateral deviation angle and change in vertebral rotation. Each parameter will be analyzed as a separate outcome measure.
Secondary outcome measures will include individual postural and functional parameters assessed separately, including trunk imbalance, trunk inclination, pelvic obliquity, pelvic torsion, pelvic rotation, kyphotic angle, lordotic angle, spinal mobility measured using an inclinometer, and health-related quality of life assessed using the Scoliosis Research Society-22 Revised (SRS-22r) questionnaire.
Measurements will be performed at baseline, 8 weeks, and 16 weeks. Statistical analysis will compare within-group and between-group changes over time using appropriate parametric and non-parametric tests, with statistical significance set at p < 0.05.
Additionally, agreement between angle of trunk rotation measured by scoliometer and vertebral rotation measured by the DIERS Formetric 3D/4D system will be evaluated as an exploratory analysis.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Kosovo
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Pristina、Kosovo、コソボ、10000
- Physical Medicine and Rehabilitation Clinic, University Clinical Center of Kosovo (UCCK)
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adolescents aged 10 to 18 years.
- Diagnosis of mild to moderate adolescent idiopathic scoliosis (AIS) with a Cobb angle between 10° and 40°.
- Referred for physiotherapy treatment at the Physical Medicine and Rehabilitation Clinic.
- Ability to participate in a 16-week exercise program.
- Written informed consent from a parent or legal guardian and assent from the participant.
- Agreement not to receive additional scoliosis-specific treatment during the study period.
Exclusion Criteria:
- Non-idiopathic scoliosis (congenital, neuromuscular, or syndromic scoliosis).
- Cervicothoracic scoliosis.
- Previous scoliosis surgery.
- Brace treatment during the study period.
- Previous scoliosis-specific physiotherapy during the study period.
- Neurological disorders affecting posture or gait.
- Congenital or structural spinal abnormalities.
- Lower extremity neuromuscular disorders.
- Leg length discrepancy.
- Cardiovascular or respiratory conditions contraindicating exercise.
- Inability to participate in the intervention or complete outcome assessments.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Structured Physiotherapeutic Corrective Exercise Program
Participants will receive a 16-week structured physiotherapeutic corrective exercise program including core stabilization, stretching, spine autocorrection, and pelvic stabilization and correction exercises.
Supervised sessions will be conducted three times per week, with additional home exercises performed two days per week.
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A 16-week structured physiotherapeutic corrective exercise program including core stabilization, stretching, spine autocorrection, and pelvic stabilization and correction exercises.
Participants will attend supervised sessions three times per week and perform home exercises two additional days per week.
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アクティブコンパレータ：Standard Physiotherapy Exercise Program
Participants will receive a standard physiotherapy exercise program consisting of conventional strengthening, stretching, postural correction, and flexibility exercises.
Supervised sessions will be conducted three times per week, with additional home exercises performed two days per week.
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The Standard Physiotherapy Exercise Program will last 16 weeks and consists of conventional therapeutic exercises aimed at improving spinal strength, flexibility, posture, and coordination in adolescents with idiopathic scoliosis.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in lateral spinal deviation
時間枠：Week 16
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Change from baseline to Week 16 in lateral spinal deviation measured by the DIERS Formetric 3D/4D system.
The outcome will be reported in degrees (°).
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Week 16
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Change in vertebral rotation
時間枠：Week 16
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Change from baseline to Week 16 in vertebral rotation measured by the DIERS Formetric 3D/4D system.
The outcome will be reported in degrees (°).
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Week 16
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in trunk imbalance
時間枠：Week 16
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Change from baseline to Week 16 in trunk imbalance measured by the DIERS Formetric 3D/4D system.
The outcome will be reported in millimeters (mm).
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Week 16
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Change in trunk inclination
時間枠：Week 16
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Change from baseline to Week 16 in trunk inclination measured by the DIERS Formetric 3D/4D system.
The outcome will be reported in degrees (°).
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Week 16
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Change in pelvic obliquity
時間枠：Week 16
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Change from baseline to Week 16 in pelvic obliquity measured by the DIERS Formetric 3D/4D system.
The outcome will be reported in degrees (°).
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Week 16
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Change in pelvic torsion
時間枠：Week 16
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Change from baseline to Week 16 in pelvic torsion measured by the DIERS Formetric 3D/4D system.
The outcome will be reported in degrees (°).
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Week 16
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Change in pelvic rotation
時間枠：Week 16
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Change from baseline to Week 16 in pelvic rotation measured by the DIERS Formetric 3D/4D system.
The outcome will be reported in degrees (°).
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Week 16
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Change in kyphotic angle
時間枠：Week 16
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Change from baseline to Week 16 in thoracic kyphotic angle measured by the DIERS Formetric 3D/4D system.
The outcome will be reported in degrees (°).
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Week 16
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Change in lordotic angle
時間枠：Week 16
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Change from baseline to Week 16 in lumbar lordotic angle measured by the DIERS Formetric 3D/4D system.
The outcome will be reported in degrees (°).
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Week 16
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Change in spinal mobility
時間枠：Week 16
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Change from baseline to Week 16 in spinal mobility measured using an inclinometer.
The outcome will be reported in degrees (°).
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Week 16
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Change in health-related quality of life
時間枠：Week 16
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Change from baseline to Week 16 in health-related quality of life assessed using the Scoliosis Research Society-22 Revised (SRS-22r) questionnaire.
Scores range from 22 to 110, with higher scores indicating better health-related quality of life.
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Week 16
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Akcay B, Colak TK, Apti A, Colak I. The Immediate Effect of Hanging Exercise and Muscle Cylinder Exercise on the Angle of Trunk Rotation in Adolescent Idiopathic Scoliosis. Healthcare (Basel). 2024 Jan 24;12(3):305. doi: 10.3390/healthcare12030305.
- Schreiber S, Parent EC, Moez EK, et al. Schroth physiotherapeutic scoliosis-specific exercises for adolescent idiopathic scoliosis. PLoS ONE. 2016;11(6):e0158739.
便利なリンク
- ClinicalTrials.gov official registry platform for clinical trial registration and results database.
- Scoliosis Research Society (SRS) provides evidence-based information and guidelines on scoliosis management and outcomes assessment.
- SOSORT (Society on Scoliosis Orthopaedic and Rehabilitation Treatment) provides international guidelines for conservative scoliosis treatment.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- UP-PT-2026-001 (その他の識別子：University of Prishtina - Faculty of Medicine)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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