Cerebral Palsy Clinical Trial
Official title:
Association Between Functional Impairment and Parenting Stress Among Children Diagnosed With Diplegic Cerebral Palsy
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 |
Verified date | June 2021 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Outpatient clinic - Faculty of Physical Therapy - Cairo University | Dokki |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
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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