- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04938063
Association Between Functional Impairment and Parenting Stress Among Children Diagnosed With Diplegic Cerebral Palsy
- To find out the relation between the severity of ADL limitation in diplegic CP children and the level of parents' stress.
- To detect the correlation between the PS level to the different domains of ADL limitation.
- To determine the substantial factors that underlying the parents' stress of those diplegic CP children.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The health and well-being of children are intimately related to their parents' physical, emotional and social health in addition to child-rearing practices. The way parents of CP children deal with their stress may adversely affect their parenting ability, which in turn leads to difficulties for the child, which may lead to more parenting stress. The extent to which parents of CP children adjust and the resources to meet the needs of their children is of primary concern to professionals working in children's healthcare.
To support parents, it is important to determine the level of independence of diplegic CP children in their daily lives. This is necessary to identify predictors of their stress, which may be a mentally debilitating factor in their lives. In return, it may support us as physiotherapists to make more informed decisions about treatment planning, as well as facilitate conversations with parents around identifying sources of stress and developing healthy coping strategies that lead to a better quality of life for their children. Finally, this will have a direct positive impact on the children's abilities
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Dokki, Egypte
- Outpatient clinic - Faculty of Physical Therapy - Cairo University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Diplegic CP children.
- Their age ranges from 18 months to five years old.
- All levels of GMFCS will be included.
- Both sexes will be included.
- All children were medically and clinically stable.
- Parents must be able to write and read.
Exclusion Criteria:
Diplegic CP children, who might have one or more of the following:
- History of chronic cardiac or chest disease.
- Any behavioral disorders.
- Current hospitalization for urgent medical reasons.
- Significant visual or auditory impairment.
- Previous history of Botox injection within last six months.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Autre
- Perspectives temporelles: Transversale
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Cerebral palsy children
Sample size estimation was carried out to determine the recruited number of the diplegic CP children from the outpatient clinic at the Faculty of Physical Therapy, Cairo University, Physical Therapy Department at the National Institute of Neuromotor Disorder, Abu El-Reesh Hospital, and private physiotherapy clinics.
The age of patients will range from 18 months to 5 years old.
Both sexes will participate in this study
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Association Between Functional Impairment and Parenting Stress Among Children Diagnosed With Diplegic Cerebral Palsy
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Assessing the change in parent stress
Délai: Baseline only
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It will be assessed by using the approved Arabic version of the Parent stress index.
The parent will be asked to read each statement carefully and focus on each statement and circle the one that best suites his psychological state concerning his child.
Parents should respond by circling SA (strongly agree), A (agree), NS (not sure), D (disagree), SD (strongly disagree).
They should circle only one response per item, and make an "X" through the response if it needs to be changed.
Parents must not erase any answers.
Parent must be Encouraged to answer all the items.
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Baseline only
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Assessing the change in children's quality of life
Délai: Baseline only
|
It will be assessed by The Pediatric Quality of Life Inventory™ (PedsQL™) Family Impact Module version 2 It is composed of parent proxy-report forms obtainable in numerous international languages including Arabic.
The Arabic version of the PedsQL™ Family Impact Module version 2.0 is a parent report instrument designed to assess the impact of pediatric chronic health conditions on parents and the family .It consists of 36 items comprising 8 dimensions.
It includes 6 subscales measuring parents' self-reported functioning: Physical Functioning (6 items), Emotional Functioning (5items), Social Functioning (4 items), Cognitive Functioning (5 items), Communication (3 items) and Worry (5 items); as well as 2 subscales measuring parent- reported family functioning: Daily Activities (3 items) and Family Relationships (5 items)
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Baseline only
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Assessing the change in children's activities of daily living
Délai: Baseline only
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It will be carried out by using self-care domain (eating, grooming, bathing, dressing upper and lower body and toileting), transfer and locomotion domains of the WeeFIM.
Assessment should be performed by direct observing the child.
However, when direct observation is not possible, interviewing parents who are familiar with the child's everyday activities is crucial
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Baseline only
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ahmed Fekry, Cairo University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- Fekry_phd
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
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