- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07847827
Fear of Falling in Stroke: Its Relationship With Motor Recovery, Stroke Duration, Trunk Control, and Balance
Factors Associated With Fear of Falling in Stroke
The aim of this study is to evaluate the relationship between fear of falling and motor recovery, stroke duration, trunk control, and balance in stroke patients.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Fear of falling is a common and disabling complication in stroke patients during the acute, subacute, and chronic stages. This observational study aims to evaluate the relationship between fear of falling and upper/lower extremity motor recovery, time since stroke, trunk control, and balance in post-stroke individuals. The investigators will assess participants using demographic information, fall history, the Montreal Cognitive Assessment, Brunnstrom Staging for upper and lower extremity motor recovery, the Falls Efficacy Scale International, the Trunk Impairment Scale, and the Tinetti Performance Oriented Mobility Assessment. Additionally, the investigators will evaluate whether clinical parameters such as motor recovery, balance and trunk control correlate with the level of fear of falling.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Lütfiye AKKURT, Assistant Professor
- Numéro de téléphone: 1446 0 (274) 260 00 43
- E-mail: lutfiye.akkurt@ksbu.edu.tr
Sauvegarde des contacts de l'étude
- Nom: Lütfiye AKKURT, PT, PhD, Assistant Professor
- Numéro de téléphone: 1446 0 (274) 260 00 43
- E-mail: lutfiye.akkurt@ksbu.edu.tr
Lieux d'étude
-
-
-
Kütahya, Turquie (Türkiye), 43100
- Kütahya Health Sciences University
-
Contact:
- Lütfiye AKKURT, PT, PhD, Assistant Professor
- Numéro de téléphone: 1446 +90 (274) 260 00 43
- E-mail: lutfiye.akkurt@ksbu.edu.tr
-
-
Kütahya
-
Kütahya, Kütahya, Turquie (Türkiye), (552) 266-8356
- Kütahya City Hospital Yoncalı Physical Therapy and Rehabilitation Location
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Stroke patients
La description
Inclusion Criteria:
- Having a diagnosis of stroke
- Aged ≥ 18 years old
- History of at least one fall
- Ability to walk 10 meters independently or with an assistive device
- Ability to understand and follow simple instructions
Exclusion Criteria:
- Having another neurological disease (except for stroke)
- Having a surgery upper or lower extremity in the last 6 months
- Unwillingness to participate
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: CROSS_SECTIONAL
Cohortes et interventions
Groupe / Cohorte |
|---|
|
Post-stroke patients
Individuals aged 18 and older diagnosed with stroke, who have a history of at least one fall, are able to walk 10 meters independently or with an assistive device, and can understand and follow simple instructions. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The Montreal Cognitive Assessment (MoCA)
Délai: Baseline
|
The Montreal Cognitive Assessment (MoCA) is a 30-point scale comprising 16 items across 11 categories used to screen for cognitive impairment in stroke and other neurological conditions, where a score of 26 or above indicates normal cognitive function. |
Baseline
|
|
Brunnstrom Recovery Stages of Upper and Lower Extremity
Délai: Baseline
|
The Brunnstrom recovery stages are a staging system that shows the motor recovery in patients with stroke. The Brunnstrom Recovery Stages of Upper and Lower Extremity of six stages. Higher stages indicate better motor function. |
Baseline
|
|
Falls Efficacy Scale-International (FES-I)
Délai: Baseline
|
The Falls Efficacy Scale-International (FES-I) is a short, easy to administer tool that measures the level of concern about falling during 16 social and physical activities inside and outside the home whether or not the person actually does the activity. The level of concern is measured on a four-point Likert scale (1=not at all concerned to 4=very concerned). Total score is between 16 and 64 points. Lower scores mean a better outcome. |
Baseline
|
|
Trunk Impairment Scale (TIS)
Délai: Baseline
|
The Trunk Impairment Scale (TIS) evaluates post-stroke trunk control across three subscales (static sitting balance, dynamic sitting balance, and coordination) with a maximum total score of 23, where higher scores reflect better trunk function. |
Baseline
|
|
Tinetti Performance Oriented Mobility Assessment (POMA) - Balance
Délai: Baseline
|
The Tinetti Performance Oriented Mobility Assessment (POMA) balance subscale comprises 9 items with a total score of 16, where higher scores indicate better balance performance. |
Baseline
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mine PEKESEN KURTÇA, PT, PhD, Assistant Professor, Ondokuz Mayıs University
- Chercheur principal: Seda Nur KEMER, PT, PhD, Lecturer, Ondokuz Mayıs University
- Chercheur principal: Barış YENEN, MD, Assistant Professor, Kütahya Health Sciences University
- Chercheur principal: Mustafa ÇETİNER, MD, Associate Professor, Kütahya Health Sciences University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026/10-51
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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
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 .