- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07922369
A Comparison of the Effects of Exercise Methods for Adolescent Hyperkyphosis on the Sensorimotor System
Comparıson Of The Effects Of Schroth And Conventıonal Exercıses On The Sensorımotor System In Adolescents Wıth Hyperkyphosıs
This study will compare two home exercise programs for adolescents aged 10-17 years with postural hyperkyphosis: kyphosis-specific Schroth exercises and traditional stretching and strengthening exercises. It will examine whether one program is more effective at improving the ability to sense and reproduce a corrected upper-back posture. The researchers expect the Schroth program to lead to greater improvement.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study will compare two home-based exercise programs for adolescents aged 10-17 years with postural hyperkyphosis. Participants will follow either kyphosis-specific Schroth exercises or conventional stretching, strengthening, and stabilization exercises for eight weeks, approximately 45 minutes per session, three days a week.
The study will assess whether the programs affect participants' ability to recognize and reproduce a corrected thoracic posture. Other outcomes will include balance, spinal curvature and posture, muscle strength and endurance, flexibility, spinal pain, and participants' perceptions of their condition and overall change. Exercise participation, how accurately the exercises are performed, and any adverse events will also be recorded.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Cisemnur Gulnaz, Physiotherapist
- Número de teléfono: +905078985406
- Correo electrónico: cisemnurgulnaz@ogr.iuc.edu.tr
Ubicaciones de estudio
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Bakırköy
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Istanbul, Bakırköy, Turquía (Türkiye)
- Istanbul University-Cerrahpaşa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
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Contacto:
- Cisemnur Gulnaz, BSc, PT
- Número de teléfono: +905078985406
- Correo electrónico: cisemnurgulnaz@ogr.iuc.edu.tr
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Investigador principal:
- Ayşe Zengin Alpözgen, Assoc. Prof.
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Sub-Investigador:
- Kübra Kardeş, Asst Prof.
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Sub-Investigador:
- Çisemnur Gülnaz, BSc
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Aged 10 through 17 years. Thoracic kyphosis Cobb angle greater than 40° and less than 70° from T4 to T12 on a lateral radiograph.
Flexible thoracic kyphosis that decreases with active correction on clinical examination.
Able to understand the exercise instructions and perform the home program. Written informed consent from a parent or legal guardian and written assent from the adolescent.
Exclusion Criteria:
Kyphosis other than postural kyphosis, including Scheuermann disease (at least 5° of wedging in three or more consecutive vertebrae), congenital kyphosis, or other structural or rigid kyphosis.
Structural scoliosis with a Cobb angle greater than 10°. Previous spinal surgery or major trauma affecting the spine. A diagnosed neurological condition or neurological symptoms that may affect postural control.
Diagnosed vestibular pathology or a history of vestibular problems, or current vertigo, dizziness, or balance complaints.
Visual impairment that cannot be corrected with glasses or contact lenses. Acute musculoskeletal injury or pain that would prevent assessment or exercise. Participation in physiotherapy or an exercise program for kyphosis within the previous 3 months.
Previous Schroth exercise training. Current brace treatment. Cognitive impairment that would prevent adherence to the exercise program.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Schroth exercise group
This group will perform a kyphosis-specific Schroth exercise program focused on active thoracic posture correction, axial elongation, and corrective breathing. Participants will practice the exercises at home, using a mirror for visual feedback and tactile cues to monitor their posture. |
Participants will perform the program at home 3 days per week for 8 weeks, with each session lasting approximately 45 minutes, including a 5-minute warm-up and a 3-minute cool-down. Three face-to-face training sessions will be provided during week 1, followed by face-to-face follow-up visits at the beginning of weeks 3 and 5. The program will have two stages. Participants who meet the prespecified progression criteria will advance to stage 2 at the week 5 follow-up. |
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Comparador activo: Conventional exercise group
This group will perform a conventional exercise program including stretching, scapular retraction, back extensor and trapezius strengthening, and trunk stabilization. The program will not include Schroth-specific active posture correction, corrective breathing, or mirror-based posture feedback. |
Participants will perform the program at home 3 days per week for 8 weeks, with each session lasting approximately 45 minutes, including a 5-minute warm-up and a 3-minute cool-down. Three face-to-face training sessions will be provided during week 1, followed by face-to-face follow-up visits at the beginning of weeks 3 and 5. The program will have two stages. Participants who meet the prespecified progression criteria will advance to stage 2 at the week 5 follow-up. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Thoracic Extension Absolute Repositioning Error
Periodo de tiempo: At baseline and at the end of Week 8
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Thoracic position sense will be assessed with dual digital inclinometers placed at T1 and T12. With eyes closed, participants will reproduce a 15° thoracic extension target. The primary measure is the mean absolute difference between the target and reproduced angles across five trials, in degrees; lower values indicate smaller error. Flexion (30°) and right and left lateral flexion (20°) will also be measured as secondary directional outcomes. |
At baseline and at the end of Week 8
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Balance
Periodo de tiempo: At baseline and at the end of Week 8
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Balance will be assessed with the AI Balance system using the modified Clinical Test of Sensory Interaction on Balance (four eyes-open/eyes-closed conditions on firm and foam surfaces; three 30-second trials per condition) and the Limits of Stability test (weight shifting toward eight targets). Higher sway index values indicate greater sway; higher Limits of Stability scores indicate better performance. |
At baseline and at the end of Week 8
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Thoracic Curvature
Periodo de tiempo: At baseline and at the end of Week 8
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Thoracic curvature will be measured with a Flexicurve ruler from C7 to T12. The kyphosis index will be calculated as the kyphosis apex depth divided by the curve length, multiplied by 100. The values above 13 indicate hyperkyphosis. |
At baseline and at the end of Week 8
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Sagittal Posture
Periodo de tiempo: At baseline and at the end of Week 8
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Sagittal posture will be assessed from a lateral photograph using the PostureScreen Mobile application. Landmark displacement will be recorded in centimeters under standardized camera, posture, clothing, and hair conditions. |
At baseline and at the end of Week 8
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Muscle Strength
Periodo de tiempo: At baseline and at the end of Week 8
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Isometric strength of the trunk flexors and extensors, upper, middle, and lower trapezius, and serratus anterior will be measured using a hand-held dynamometer and the make-test method. Three 5-second contractions will be performed for each muscle group. Mean force will be normalized to body weight and reported in N/kg. |
At baseline and at the end of Week 8
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Flexibility
Periodo de tiempo: At baseline and at the end of Week 8
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Hamstring and lower-back flexibility will be measured with the sit-and-reach test; the maximum distance across three trials will be recorded in centimeters. Pectoralis minor muscle length will be measured bilaterally with a tape measure; the mean of three measurements will be analyzed. |
At baseline and at the end of Week 8
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Muscle Endurance
Periodo de tiempo: At baseline and at the end of Week 8
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Scapular, trunk flexor, and trunk extensor endurance will be assessed using the isometric scapular endurance, McGill trunk flexor endurance, and Biering-Sørensen tests, respectively. The time each position is maintained without compensation will be recorded in seconds. Each test will be performed once, with at least 5 minutes of rest between tests. |
At baseline and at the end of Week 8
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Spinal Pain
Periodo de tiempo: At baseline and at the end of Week 8
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Resting, activity-related, and nocturnal spinal pain during the previous week will be rated on a 0-10 cm Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst possible pain. |
At baseline and at the end of Week 8
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Deformity Perception
Periodo de tiempo: At baseline and at the end of Week 8
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Deformity perception will be assessed with the Turkish version of the Kyphosis-Specific Spinal Appearance Questionnaire. The 10-item questionnaire is scored from 1 to 5; the mean item score will be analyzed. Higher scores indicate a more negative perception of spinal appearance. |
At baseline and at the end of Week 8
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Perceived Global Change
Periodo de tiempo: At the end of Week 8
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Overall perceived change will be assessed using the 7-point Global Rating of Change scale, from -3 (much worse) to +3 (much better), with 0 indicating no change. Scores of +2 or +3 will indicate a clinically meaningful perceived improvement. |
At the end of Week 8
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Elpeze G, Usgu G. The Effect of a Comprehensive Corrective Exercise Program on Kyphosis Angle and Balance in Kyphotic Adolescents. Healthcare (Basel). 2022 Dec 8;10(12):2478. doi: 10.3390/healthcare10122478.
- Akyurek E, Zengin Alpozgen A, Akgul T. The preliminary results of physiotherapy scoliosis-specific exercises on spine joint position sense in adolescent idiopathic scoliosis: A randomized controlled trial. Prosthet Orthot Int. 2022 Oct 1;46(5):510-517. doi: 10.1097/PXR.0000000000000136. Epub 2022 Jun 7.
- Cakir B, Ozdemi̇r Gorgu S. Associations between postural kyphosis and tactile sensation, proprioception, and body image in young individuals: an analytical cross-sectional study. BMC Musculoskelet Disord. 2026 Apr 9;27(1):425. doi: 10.1186/s12891-026-09800-2.
- Ozdemir Gorgu S, Algun ZC. A randomized controlled study of the effect of functional exercises on postural kyphosis: Schroth-based three-dimensional exercises versus postural corrective exercises. Disabil Rehabil. 2023 Jun;45(12):1992-2002. doi: 10.1080/09638288.2022.2083244. Epub 2022 Jun 12.
Fechas de registro del estudio
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Finalización del estudio (Estimado)
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Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
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Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IstanbulUC-FTR-CG-01
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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