Association Between Functional Impairment and Parenting Stress Among Children Diagnosed with Diplegic Cerebral Palsy
1 other identifier
observational
107
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2021
CompletedFirst Submitted
Initial submission to the registry
June 18, 2021
CompletedFirst Posted
Study publicly available on registry
June 24, 2021
CompletedNovember 22, 2024
November 1, 2024
5 months
June 18, 2021
November 20, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (1)
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
Interventions
Association Between Functional Impairment and Parenting Stress Among Children Diagnosed With Diplegic Cerebral Palsy
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Outpatient clinic - Faculty of Physical Therapy - Cairo University
Dokki, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Fekry
Cairo University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 18, 2021
First Posted
June 24, 2021
Study Start
January 1, 2021
Primary Completion
May 30, 2021
Study Completion
June 15, 2021
Last Updated
November 22, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share