- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07680374
Dance-Based Exercise in Adolescent Idiopathic Scoliosis
Effects of Dance-Based Exercises on Physical Fitness, Body Image, and Quality of Life in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity associated with physical and psychosocial impairments. Although conventional exercise programs are beneficial, maintaining long-term adherence may be challenging in adolescents. Dance-based exercise programs offer a potentially enjoyable and motivating alternative.
This prospective randomized controlled study will include 24 adolescents with AIS aged 10-18 years. Participants will be randomly allocated into an intervention group and a control group (12 participants per group). Both groups will perform conventional scoliosis exercises, while the intervention group will additionally participate in dance-based exercise sessions for six weeks.
Assessments will be conducted at baseline and after six weeks. Primary outcomes will include body image and health-related quality of life. Secondary outcomes will include physical fitness, flexibility, trunk rotation, and enjoyment of physical activity.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Istanbul Atlas University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age between 10 and 18 years
- Diagnosis of adolescent idiopathic scoliosis
- Cobb angle between 10° and 30°
- No previous dance training
- Not participating regularly in another exercise program
Exclusion Criteria:
- Previous scoliosis surgery
- Neuromuscular or congenital scoliosis
- Neurological, orthopedic, psychiatric, cardiovascular, or pulmonary disorders -preventing exercise participation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Dance-Based Exercise Group
Participants will perform conventional scoliosis exercises and additional dance-based exercises for six weeks.
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Participants will receive dance-based exercise sessions for 6 weeks (one face-to-face and one online session per week) in addition to conventional scoliosis exercises.
Participants will perform only conventional scoliosis exercises for six weeks.
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Comparador activo: Conventional Scoliosis Exercise Program
Participants will perform conventional scoliosis exercises during the 6-week study period.
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Participants will perform only conventional scoliosis exercises for six weeks.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Flexibility-Forward Bending Test
Periodo de tiempo: Baseline and 6 weeks
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Spinal flexibility will be assessed using the Forward Bending Test.
Participants will bend forward from a standing position with the knees fully extended and attempt to reach toward the floor.
The distance between the tip of the middle finger and the floor will be measured in centimeters.
Lower values indicate greater trunk and posterior chain flexibility.
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Baseline and 6 weeks
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Flexibility-Lateral Flexion Test
Periodo de tiempo: Baseline and 6 Weeks
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Trunk lateral flexibility will be assessed using the Lateral Flexion Test.
Participants will perform maximal lateral trunk flexion to each side while standing with the knees extended.
The distance reached by the tip of the middle finger along the lateral aspect of the thigh will be measured in centimeters.
Higher values indicate greater lateral trunk flexibility.
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Baseline and 6 Weeks
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Core Muscle Endurance-Trunk Flexion Test
Periodo de tiempo: Baseline and 6 weeks
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The endurance of the trunk flexor muscles will be assessed using the Trunk Flexion Test.
Participants will maintain the standardized trunk flexion position for as long as possible.
Performance will be recorded as endurance time in seconds.
Higher values indicate greater trunk flexor muscle endurance.
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Baseline and 6 weeks
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Core Muscle Endurance-Lateral Bridge Test
Periodo de tiempo: Baseline and 6 Weeks
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Lateral core muscle endurance will be assessed using the Lateral Bridge Test.
Participants will maintain the side bridge position for as long as possible.
Endurance time will be recorded in seconds, with higher values indicating better lateral trunk muscle endurance.
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Baseline and 6 Weeks
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Core Muscle Endurance - Prone Bridge Test
Periodo de tiempo: Baseline and 6 Weeks
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Global core muscle endurance will be assessed using the Prone Bridge Test.
Participants will maintain the prone bridge (plank) position for as long as possible.
Performance will be recorded as endurance time in seconds.
Higher values indicate greater global core muscle endurance.
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Baseline and 6 Weeks
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Core Muscle Endurance- Modified Biering-Sorensen Test
Periodo de tiempo: Baseline and 6 Weeks
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The endurance of the trunk extensor muscles will be assessed using the Modified Biering-Sørensen Test.
Participants will maintain the standardized horizontal trunk position for as long as possible.
Performance will be recorded as endurance time in seconds.
Higher values indicate greater trunk extensor muscle endurance.
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Baseline and 6 Weeks
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Functional Exercise Capacity
Periodo de tiempo: Baseline and 6 Weeks
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6 Minute Walk Test
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Baseline and 6 Weeks
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Dynamic Balance
Periodo de tiempo: Baseline and 6 Weeks
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Y Balance
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Baseline and 6 Weeks
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Trunk Rotation
Periodo de tiempo: Baseline and 6 Weeks
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Thoracic and Lumbar Rotation Measurements
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Baseline and 6 Weeks
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Body Image-Walter Reed Visual Assessment Scale
Periodo de tiempo: Baseline and 6 Weeks
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Perceived trunk deformity will be assessed using the Walter Reed Visual Assessment Scale (WRVAS).
The WRVAS is a patient-reported outcome measure consisting of seven items evaluating the perceived severity of spinal deformity through standardized illustrations.
Each item is scored on a 5-point scale, yielding a total score ranging from 7 to 35.
Higher scores indicate greater perceived spinal deformity.
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Baseline and 6 Weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Health-Related Quality of Life-Scoliosis Research Society-22 Questionnaire
Periodo de tiempo: Baseline and 6 Weeks
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Health-related quality of life will be assessed using the Scoliosis Research Society-22 Questionnaire (SRS-22).
The questionnaire consists of 22 items evaluating five domains: function/activity, pain, self-image, mental health, and satisfaction with management.
Each item is scored on a 5-point Likert scale.
The total (or mean) score will be calculated, with higher scores indicating better health-related quality of life.
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Baseline and 6 Weeks
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Enjoyment of Physical Activity
Periodo de tiempo: Baseline and 6 Weeks
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Physical Activity Enjoyment Scale
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Baseline and 6 Weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Meltem Kaya, Assoc. Prof., Atlas University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AtlasUmkaya06
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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