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L'essai clinique NCT06082739 pour Cyphose est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Managing Kyphosis With Exercise
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT06082739 est un essai interventionnel pour Cyphose. Son statut actuel est : en recrutement. L'étude a débuté le 6 novembre 2023 et vise à recruter 120 participants. Dirigé par Cedars-Sinai Medical Center, l'essai devrait être terminé d'ici le 1 octobre 2029. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 17 janvier 2025.
Résumé succinct
The primary objective of this study is to determine if stretching exercises as a conservative treatment option will correct kyphosis in postural and Scheuermann's kyphosis.
Description détaillée
Despite comprehensive documentation of surgical interventions in existing literature, the investigation into non-operative approaches for addressing hyperkyphosis or Scheuermann's kyphosis in the pediatric population has been investigated with inconsistent findings. Various outcomes have been observed with regard to the effectiveness of multiple brace treatment options, alongside recommendations for various physiotherapeutic approaches, either in conjunction with brace treatment or as standalone interventions.
However, there is no universally accepted consensus regarding the conservative management of kyphosis that simultaneously ensures substantial patient satisfaction and heightened bodily awareness. Notably, there have been no studies investigating the efficacy of stretching in the treatment of individuals with kyphosis.
Titre officiel
Effectiveness of Various Exercises in Managing Kyphosis
Conditions
CyphosePublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:- Priftis KN, Hager J, Vlachou M, Anthracopoulos MB. Effects of bracing on lung function in idiopathic juvenile kyphosis. Pediatr Pulmonol. 2003 Feb;35(2):83-6. doi: 10.1002/ppul.10220.
- Karavidas NS. Bracing for Adolescent Idiopathic Scoliosis (AIS) and Scheuermann Kyphosis: the issue of overtreatment in Greece. Scoliosis Spinal Disord. 2016 Oct 14;11(Suppl 2):30. doi: 10.1186/s13013-016-0095-6. eCollection 2016.
- Mehdikhani M, Behtash H, Ganjavian MS, Khalaj N. Orthotic treatment of idiopathic hyperkyphosis with Milwaukee brace. J Back Musculoskelet Rehabil. 2016 Aug 10;29(3):515-9. doi: 10.3233/BMR-150651.
- Pizzutillo PD. Nonsurgical treatment of kyphosis. Instr Course Lect. 2004;53:485-91.
- Riddle EC, Bowen JR, Shah SA, Moran EF, Lawall H Jr. The duPont kyphosis brace for the treatment of adolescent Scheuermann kyphosis. J South Orthop Assoc. 2003 Fall;12(3):135-40.
- Tsirikos AI, Jain AK. Scheuermann's kyphosis; current controversies. J Bone Joint Surg Br. 2011 Jul;93(7):857-64. doi: 10.1302/0301-620X.93B7.26129.
- 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.
Autres identifiants de l'essai
- STUDY00002960
Numéro NCT
Date de début (réel)
2023-11-06
Dernière mise à jour publiée
2025-01-17
Date de fin (estimée)
2029-10
Inscription (estimée)
120
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Scheuermann's
thoracolumbar
postural
stretching
back
thoracolumbar
postural
stretching
back
Objectif principal
Traitement
Plan d'attribution
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalExercise group Patients perform stretching exercises daily. | Exercices Stretching exercises with and without a bolster, ball, or foam roller. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Kyphosis angle | Change in severity of kyphosis angle evaluated using radiographs | Enrollment, 6-month follow-up, 2-year follow-up |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Patient Satisfaction and Perception | Patient Satisfaction and Perception measured via questionnaires | Enrollment, 6-month follow-up, 2-year follow-up |
Parental Perception | Parental Perception of kyphosis measured via questionnaires | Enrollment, 6-month follow-up, 2-year follow-up |
Exercise Adherence | Exercise Adherence measured via questionnaires | Enrollment, 6-month follow-up, 2-year follow-up |
Critères d'éligibilité
Âges éligibles
Enfant, Adulte, Adulte âgé
Âge minimum
8 Years
Sexes éligibles
Tous
- Patients ages 8 and older with postural or Scheuermann's kyphosis with >45° of kyphosis or >10° of thoracolumbar kyphosis from T11-L1 or other cases which seem to have excessive kyphosis.
- Parents of patients aged 17 and younger who are 18 and older and cognitively able to complete a survey will be included in the study as well.
- Patients with congenital kyphosis or scoliosis greater than 30°.
- Parents of patients aged 17 and younger who are less than 18 years of age or cognitively unable to complete a survey will be excluded from the study.
- Any records flagged "break the glass" or "research opt out."
Cedars-Sinai Medical CenterPartie responsable de l'essai
David Skaggs, Investigateur principal, Director Spine Center, Cedars-Sinai Medical Center
Contact central de l'essai
Contact: Cristabelle Alexander, BS, 310-423-1061, [email protected]
1 Centres de l'essai dans 1 pays
California
Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States
Cristabelle Alexander, BS, Contact, 310-423-1061, [email protected]
David L Skaggs, MD, MMM, Investigateur principal
En recrutement