- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07758712
Effectiveness of a Horse Riding Simulator in Adolescents With Idiopathic Scoliosis
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity associated with impaired respiratory muscle strength, balance, postural control, body image, and health-related quality of life. Core stabilization exercises are widely used in the conservative management of AIS. Horse riding simulator training reproduces the multidirectional rhythmic movements of horseback riding while eliminating the potential risks associated with conventional hippotherapy and may provide additional benefits for postural control and trunk muscle activation.
The aim of this randomized controlled trial is to investigate the effects of adding horse riding simulator training to a core stabilization exercise program on respiratory muscle strength, balance, health-related quality of life, and perceived cosmetic deformity in adolescents with idiopathic scoliosis. Participants will be randomly assigned to either an experimental group receiving horse riding simulator training combined with core stabilization exercises or a control group receiving core stabilization exercises alone. Outcomes will be assessed before and after the 12-week intervention.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sefa Yıldırım
- Numéro de téléphone: +905385984870
- E-mail: syildirim@bezmialem.edu.tr
Lieux d'étude
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Istanbul, Turquie (Türkiye)
- Recrutement
- Bezmialem Vakıf University
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Contact:
- Sefa Yıldırım
- Numéro de téléphone: +905395984870
- E-mail: syildirim@bezmialem.edu.tr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Diagnosis of adolescent idiopathic scoliosis
- Age between 10 and 19 years
- Cobb angle between 10° and 40°, measured on standing spinal radiographs
- Willingness of the participant and, when applicable, the parent or legal guardian to participate in the study
Exclusion Criteria:
- Scoliosis of a non-idiopathic etiology
- History of surgery within the previous 3 months
- Presence of an orthopedic, neurological, or systemic condition that may prevent participation in the exercise program
- Cognitive, communication, or behavioral disorders that may interfere with understanding instructions, answering questions, or performing the exercises
- Participation in regular exercise on 3 or more days per week
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Horse Riding Simulator + Core Stabilization
Participants will receive supervised 60-minute core stabilization exercises combined with 30-minute horse riding simulator training twice weekly for 12 weeks.
Home-based core stabilization exercises will be performed on the remaining days of the week.
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Participants will receive 30-minute horse riding simulator training twice weekly for 12 weeks in addition to supervised core stabilization exercises.
Each session consists of 5 minutes of warm-up at low speed, 20 minutes of training at the highest speed tolerated by the participant, and 5 minutes of cool-down at low speed.
Participants will perform supervised 60-minute core stabilization exercises twice weekly for 12 weeks.
Home-based core stabilization exercises will be prescribed for the remaining days of the week.
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Comparateur actif: Core Stabilization
Participants will receive supervised 60-minute core stabilization exercises twice weekly for 12 weeks.
Home-based core stabilization exercises will be performed on the remaining days of the week.
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Participants will perform supervised 60-minute core stabilization exercises twice weekly for 12 weeks.
Home-based core stabilization exercises will be prescribed for the remaining days of the week.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Balance
Délai: Baseline and after 12 weeks
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Balance will be assessed using the Biodex Balance System.
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Baseline and after 12 weeks
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Respiratory Muscle Strength
Délai: Baseline and after 12 weeks
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Respiratory muscle strength will be assessed by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using a portable mouth pressure device.
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Baseline and after 12 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Health-Related Quality of Life
Délai: Baseline and after 12 weeks
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Health-related quality of life will be evaluated using the Scoliosis Research Society-22 (SRS-22) questionnaire.
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Baseline and after 12 weeks
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Perceived Cosmetic Deformity
Délai: Baseline and after 12 weeks
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Perceived cosmetic deformity will be assessed using the Walter Reed Visual Assessment Scale (WRVAS).
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Baseline and after 12 weeks
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- BVUsyildirim04
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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