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- Essai clinique NCT07581535
Effects of Cervical and Oculomotor Exercises on Functional Status, Balance, and Proprioception in Chronic Ankle Instability
4 juin 2026 mis à jour par: Simge Nur UNGAN, Izmir Katip Celebi University
Effects of Cervical and Oculomotor Exercises Added to Conventional Treatment on Ankle Functional Status, Balance, and Proprioception in Individuals With Chronic Ankle Instability: A Randomized Controlled Trial
Effects of Cervical and Oculomotor Exercises on Functional Status, Balance, and Proprioception in Chronic Ankle Instability
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
Effects of Cervical and Oculomotor Exercises Added to Conventional Treatment on Ankle Functional Status, Balance, and Proprioception in Individuals with Chronic Ankle Instability: A Randomized Controlled Trial
Type d'étude
Interventionnel
Inscription (Estimé)
38
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Simge N UNGAN, Phsiotherapist
- Numéro de téléphone: +90 507 648 5776
- E-mail: ungansimgenur@gmail.com
Lieux d'étude
-
-
Çiğli
-
Izmir, Çiğli, Turquie (Türkiye), 35650
- Recrutement
- Izmir Katip Celebi University Physiotherapy and Rehabilitation Department
-
Contact:
- Damla Karabay
- Numéro de téléphone: +902323293535
- E-mail: damla.gulpinar@ikcu.edu.tr
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Diagnosed with unilateral chronic ankle instability (CAI) in accordance with the International Ankle Consortium recommendations
- A history of at least one significant lateral ankle sprain that occurred at least 12 months prior to participation, resulting in inflammatory symptoms such as pain and swelling and causing at least one day of interruption in physical activity
- A history of "giving way" and/or recurrent ankle sprains and/or a feeling of instability in the affected ankle within the past 6 months
- A Cumberland Ankle Instability Tool (CAIT) score of ≤ 25
Exclusion Criteria:
- History of surgery or fracture in the lower extremities or spine
- Acute musculoskeletal injury affecting other joints of the lower extremity within the past 3 months (e.g., sprains, fractures) that impaired joint integrity and function and caused at least one day of interruption in physical activity
- History of injection in the affected ankle
- History of ankle sprain in the affected extremity within the past 4 weeks
- Presence of systemic musculoskeletal disorders, neurological disorders, vestibular disorders, or any other condition that may affect balance or sensory function
- Previous participation in any rehabilitation program for the ankle or cervical region
- History of head or neck trauma or diagnosed pathology within the past 12 months
- History of neck pain greater than 3/10 in severity within the past 12 months
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Conventional Treatment + Cervical and Oculomotor Exercises
Participants in the experimental group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.
In addition, they will perform cervical stabilization and oculomotor exercises.
The intervention will be conducted for 4 weeks, with 3 sessions per week.
Participants will follow a home exercise program that includes ankle mobility, strengthening, balance, and oculomotor exercises on days when they do not attend the clinic.
|
Participants in the experimental group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.
In addition, they will perform cervical stabilization and oculomotor exercises.
Participants in the control group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.
|
|
Comparateur actif: Conventional Treatment
Participants in the control group will receive a conventional rehabilitation program consisting of mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.
The intervention will be conducted for 4 weeks, with 3 sessions per week.
Participants will follow a home exercise program that includes ankle mobility, strengthening and balance exercises on days when they do not attend the clinic.
|
Participants in the experimental group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.
In addition, they will perform cervical stabilization and oculomotor exercises.
Participants in the control group will receive a conventional rehabilitation program including mobility, strengthening, balance, and proprioceptive exercises targeting the ankle joint.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Y-Balance Test
Délai: Baseline and post-intervention (after 4 weeks)
|
Dynamic balance performance assessed using balance tests (Y-Balance Test)
|
Baseline and post-intervention (after 4 weeks)
|
|
Foot and Ankle Ability Measure (FAAM)
Délai: Baseline and post-intervention (after 4 weeks)
|
Functional status assessed using the Foot and Ankle Ability Measure (FAAM) The daily living activities subscale contains 21 items; the minimum score is 0 and the maximum score is 84.
The sports subscale consists of 8 items; the minimum score is 0 and the maximum score is 32.
A higher score represents a higher level of physical function.
|
Baseline and post-intervention (after 4 weeks)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Ankle Joint Position Error Test
Délai: Baseline and post-intervention (after 4 weeks)
|
Ankle proprioception assessed using laser beam device joint position error (JPE) tests
|
Baseline and post-intervention (after 4 weeks)
|
|
Weight Bearing Lunge Test
Délai: Baseline and post-intervention (after 4 weeks)
|
Ankle dorsiflexion range of motion will be assessed with the weight bearing lunge test
|
Baseline and post-intervention (after 4 weeks)
|
|
Computerized balance assessment
Délai: Baseline and post-intervention (after 4 weeks)
|
Postural stability will be assessed using the Prokin Tecnobody balance assessment system.
|
Baseline and post-intervention (after 4 weeks)
|
|
Side Hop Test
Délai: Baseline and post-intervention (after 4 weeks)
|
Side hop test will be used to assess the dynamic postural control capacity around the ankle.
|
Baseline and post-intervention (after 4 weeks)
|
|
Ankle Pain
Délai: Baseline and post-intervention (after 4 weeks)
|
Ankle pain will be assessed using a visual analog scale (VAS).
The VAS is a scale ranging from 0 (no pain) to 10 (most severe pain), with higher scores indicating greater pain.
|
Baseline and post-intervention (after 4 weeks)
|
|
Cervical Joint Position Error Test
Délai: Baseline and post-intervention (after 4 weeks)
|
Cervical proprioception will be assessed using the Cervical Joint Position Error Test.
|
Baseline and post-intervention (after 4 weeks)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Damla KARABAY, Assistant Professor, Izmir Katip Celebi University
- Chercheur principal: Simge N UNGAN, Physiotherapist (Bachelor), Izmir Katip Celebi University
- Directeur d'études: Sercan Çapkın, Associate Professor, İzmir Bakırçay University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
7 juin 2026
Achèvement primaire (Estimé)
7 juin 2027
Achèvement de l'étude (Estimé)
7 juin 2027
Dates d'inscription aux études
Première soumission
29 avril 2026
Première soumission répondant aux critères de contrôle qualité
6 mai 2026
Première publication (Réel)
12 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2586
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Description du régime IPD
A final decision regarding the sharing of individual participant data has not yet been made due to considerations related to data protection regulations.
If a decision to share is made in the future, only de-identified data relevant to the published results may be shared upon reasonable request and in accordance with applicable regulations.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .