Cerebral PalsyNCT04938063
Association Between Functional Impairment and Parenting Stress Among Children Diagnosed with Diplegic Cerebral Palsy
An observational study of Cerebral Palsy and Parent-Child Relations, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 months to 5 years
- Conditions the study is for
- Cerebral Palsy, Parent-Child Relations
- What is being tested?
- Assessing the correlation between Functional Impairment and Parenting Stress
- How many people
- 107 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 15 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic - Faculty of Physical Therapy - Cairo University
Dokki
About this study
- 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.
Read the detailed 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
- Conditions
- Cerebral Palsy, Parent-Child Relations
- Being tested
- Assessing the correlation between Functional Impairment and Parenting Stress
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessing the correlation between Functional Impairment and Parenting StressOther
Association Between Functional Impairment and Parenting Stress Among Children Diagnosed With Diplegic Cerebral Palsy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Assessing the correlation between Functional Impairment and Parenting Stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
Measured: Baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Jan 2021
- Primary completion30 May 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed fekry ibrahim salman, Cairo University
- Investigators
- Ahmed Fekry, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938063
- Sponsor's protocol ID
- Fekry_phd
- Status last verified
- Nov 2024
- First submitted
- 18 Jun 2021
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Functional Impairment and Parenting Stress Among Children Diagnosed with Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04938063
- Acronym / sponsor ID
- Fekry_phd
- Conditions
- Cerebral Palsy, Parent-Child Relations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Detailed 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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral palsy children | – | Other: Assessing the correlation between Functional Impairment and Parenting StressSample 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 |
Who may qualify
- Ages
- 18 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- Diplegic CP children, who might have one or more of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessing the correlation between Functional Impairment and Parenting StressAssociation Between Functional Impairment and Parenting Stress Among Children Diagnosed With Diplegic Cerebral Palsy | Other | Cerebral palsy children |
Primary outcome
Assessing the change in parent stress
Time frame: 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.
Assessing the change in children's quality of life
Time frame: 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)
Assessing the change in children's activities of daily living
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Fekry principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Parent-Child Relations, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change in parent stress (time frame: Baseline only). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.