An observational study in Stress, Diaplegia and Cerebral Palsy, sponsored by Sinai University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Sinai University · Observational
PURPOSE:
To estimate the relationships between the child, parents, and family factors and parent stress and QoL among parents of children with diplegic CP.
BACKGROUND:
Cerebral palsy (CP) is considered the primary reason of motor impairment among children worldwide. Compared to parents of typically developing children, parents of children with cerebral palsy (CP) experience higher levels of stress and reduced quality of life (QoL).
HYPOTHESES:
There is no relation between the level of functional impairment among children with diplegic CP and their parental stress and QOL.
RESEARCH QUESTION:
Is there a relationship between the level of functional impairment among children with diplegic CP and the degree of their parental stress and quality of life?
1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's enrollment of 100 is above the median of 63 across 465 observational studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Sinai University is the lead sponsor of 24 studies on the registry; 11 are open to participants now.
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Parents of Children with diplegic CP age range 2 to 4.5
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Parents of children between the ages of 2 and 4.8 who had been diagnosed with diplegic CP.
Exclusion Criteria:
Parents of children between the ages of 2 and 4.8 who had been diagnosed with diplegic CP and were in a stable clinical and medical state will be included in this study. However, parents of children with behavioral problems, a history of ongoing heart disease, a botulinum toxin injection within the six months previous to the study, chronic chest disease, significant visual or auditory impairment, or parents with limited literacy will not allowed to participate in the study
Parental stress
Parental stress will be measured by the Arabic version of the parent stress index-short form (PSI-SF) . PSI-SF is a self-reported questionnaire with 36 items rated on a 5-point Likert scale (strongly agree or strongly disagree). The score of the measure ranged between 36 and 180, and a lower score indicates a better outcome.
Time frame: 1 day - one session
Quality of life of parents
Quality of life (QoL) will be measured by the family impact module (PedsQL) and quality-of-life inventory.
Time frame: 1 day - one session
Gross motor impairments
Gross motor impairments will be assessed via gross motor classification system
Time frame: 1 day - one session
Plan to share: Undecided — Privacy Concerns: IPD can be very detailed and contain sensitive information about participants, such as their medical history, diagnoses, and treatment responses. Sharing this data could potentially identify participants, even if it is de-identified. This can be a major concern, especially for studies involving rare diseases or conditions. Data Security: Making IPD publicly available raises risks of data breaches or unauthorized access. Researchers need to be confident they have robust security measures in place to protect sensitive participant information.
Ran from Jun 2024 to primary completion in Aug 2024, 1 month.
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Sinai University