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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04938063
Other study ID # Fekry_phd
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date June 15, 2021

Study information

Verified date June 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. To find out the relation between the severity of ADL limitation in diplegic CP children and the level of parents' stress. 2. To detect the correlation between the PS level to the different domains of ADL limitation. 3. To determine the substantial factors that underlying the parents' stress of those diplegic CP children.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date June 15, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Months to 5 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assessing the correlation between Functional Impairment and Parenting Stress
Association Between Functional Impairment and Parenting Stress Among Children Diagnosed With Diplegic Cerebral Palsy

Locations

Country Name City State
Egypt Outpatient clinic - Faculty of Physical Therapy - Cairo University Dokki

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessing the change in parent stress 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
Primary Assessing the change in children's quality of life 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
Primary Assessing the change in children's activities of daily living 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
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