- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Dokki, Egypt
- Outpatient clinic - Faculty of Physical Therapy - Cairo University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Annen
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
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
|
Association Between Functional Impairment and Parenting Stress Among Children Diagnosed With Diplegic Cerebral Palsy
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Assessing the change in parent stress
Tidsramme: Baseline only
|
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.
|
Baseline only
|
Assessing the change in children's quality of life
Tidsramme: 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)
|
Baseline only
|
Assessing the change in children's activities of daily living
Tidsramme: Baseline only
|
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
|
Baseline only
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ahmed Fekry, Cairo University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Fekry_phd
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Cerebral parese
-
UMC UtrechtFullførtKardiopulmonal bypass | Cerebral perfusjon | Cerebral oksygeneringNederland
-
Seoul National University HospitalRekrutteringCerebral blodstrømKorea, Republikken
-
University of MichiganFullførtCerebral hypoperfusjonForente stater
-
Seoul National University HospitalFullførtCerebral oksygenmetningKorea, Republikken
-
Medical University of ViennaUkjentCerebral oksygenering
-
Icahn School of Medicine at Mount SinaiAvsluttetCerebral Oxygen Monitoring During Surgery and Recovery After Surgery in Patients Having Lung SurgeryCerebral oksygendesaturasjonForente stater
-
Poznan University of Medical SciencesFullførtCerebral oksygeneringPolen
-
Papworth Hospital NHS Foundation TrustCambridge University Hospitals NHS Foundation TrustHar ikke rekruttert ennå
-
University of ManitobaHealth Sciences Centre, Winnipeg, Manitoba; Natural Sciences and Engineering...RekrutteringCerebral autoreguleringskartleggingCanada
-
Assistance Publique - Hôpitaux de ParisRekrutteringCerebral arteriopatiFrankrike