Cerebral PalsyNCT07846917
Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use
An observational study of Cerebral Palsy and Sleep Disorders, run by Atılım University at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to compare sleep quality, caregiver burden, stress, and self-efficacy between parents of children with spastic diplegic cerebral palsy who use night orthoses and those who do not. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Palsy, Sleep Disorders, Caregiver Burden
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Approximately 150 parents of children aged 6-15 years with spastic diplegic cerebral palsy will be included. Parents will be classified into two groups according to their children's existing night orthosis use. Parental sleep quality, caregiver burden, parenting stress, and self-efficacy will be compared between groups.
Who may be able to join
- Being the parent of a child aged 6-15 years diagnosed with spastic diplegic cerebral palsy.
- Being the child's primary caregiver.
- Having provided active care for at least 6 months.
- Being literate.
- Providing informed consent to participate in the study.
Who cannot join
- Parent-related criteria:
- Having a diagnosed severe psychiatric disorder.
- Regular use of medications affecting sleep patterns (e.g., sedatives).
- Having a severe chronic disease (e.g., advanced cardiac or renal disease).
- Having experienced a major acute stressor (e.g., bereavement or trauma) within the previous month.
- Having a primary neurological disorder directly affecting sleep.
Show all 10Show fewer
- Child-related criteria:
- Having undergone orthopedic surgery within the previous 3 months.
- Having received botulinum toxin injections within the previous 3 months.
- Having severe epilepsy or a history of uncontrolled seizures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Atılım University
Ankara
Süleyman Korkusuz, PhD, +90 538 867 54 80, suleyman.korkusuz@atilim.edu.tr
About this study
Official title: Comparison of Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy Between Parents of Children With Spastic Diplegic Cerebral Palsy Who Use and Do Not Use Night Orthoses
This observational study aims to compare sleep quality, caregiver burden, stress, and self-efficacy between parents of children with spastic diplegic cerebral palsy who use night orthoses and those who do not. Approximately 150 parents will be included and divided into two groups according to their children's night orthosis use. The study will investigate whether night orthosis use is associated with differences in parental sleep quality, caregiver burden, stress, and self-efficacy.
Read the detailed description
Children with spastic diplegic cerebral palsy may experience sleep disturbances that can affect their parents' sleep quality and caregiving responsibilities. Night orthoses are commonly used in the management of cerebral palsy; however, their relationship with parental sleep quality and psychosocial outcomes remains unclear.
This observational, comparative study will include approximately 150 parents of children with spastic diplegic cerebral palsy. Participants will be divided into two groups: parents of children who use night orthoses and parents of children who do not use night orthoses.
Parental sleep quality, caregiver burden, stress, and self-efficacy will be assessed using standardized questionnaires. The outcomes will be compared between the two groups to examine potential associations with night orthosis use.
The findings may contribute to a better understanding of the relationship between night orthosis use and parental well-being and may help inform family-centered rehabilitation approaches.
- Conditions
- Cerebral Palsy, Sleep Disorders, Caregiver Burden
- Keywords
- Spastic Diplegic Cerebral Palsy, Night Orthosis, Sleep Quality, Caregiver Burden, Parental Stress, Parental Self-Efficacy
- Medical subject headings
- Cerebral Palsy, Sleep Wake Disorders, Caregiver Burden, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parents of Children Using Night Orthoses | Parents of children with spastic diplegic cerebral palsy who regularly use night orthoses. Parental sleep quality, caregiver burden, perceived stress, and self-efficacy will be assessed. | |
| Parents of Children Not Using Night Orthoses | Parents of children with spastic diplegic cerebral palsy who do not use night orthoses. Parental sleep quality, caregiver burden, perceived stress, and self-efficacy will be assessed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
Parental sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire evaluating sleep quality over the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A score greater than 5 indicates poor sleep quality.
Measured: At baseline (single assessment)
Zarit Burden Interview
Caregiver burden will be assessed using the Zarit Burden Interview (ZBI), a 22-item self-report questionnaire evaluating the physical, emotional, social, and economic burden of caregiving. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 88. Higher scores indicate greater caregiver burden.
Measured: At baseline (single assessment)
Parenting Stress Index-Short Form (PSI-SF)
Parenting stress will be assessed using the Parenting Stress Index-Short Form (PSI-SF), a 36-item questionnaire comprising three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Total scores range from 36 to 180, with higher scores indicating greater parenting stress.
Measured: At baseline (single assessment).
Parental Self-Efficacy Scale
Parental self-efficacy will be assessed using the 17-item Parental Self-Efficacy Scale. The Turkish version will be used to evaluate parents' perceived confidence in their parenting abilities. Each item is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree), yielding a total score ranging from 17 to 119. Higher scores indicate greater parental self-efficacy and therefore a better outcome.
Measured: At baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Süleyman Korkusuz, Atılım University
- Investigators
- Süleyman Korkusuz, PhD, Principal investigator, Atılım University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846917
- Sponsor's protocol ID
- E-59394181-100-137245
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lang CP, Boucaut A, Guppy M, Johnston LM. Children with cerebral palsy: A cross-sectional study of their sleep and their caregiver's sleep quality, psychological health and well-being. Child Care Health Dev. 2021 Nov;47(6):859-868. doi: 10.1111/cch.12897. Epub 2021 Jul 26.
PubMed 34265112Mol EM, Monbaliu E, Ven M, Vergote M, Prinzie P. The use of night orthoses in cerebral palsy treatment: sleep disturbance in children and parental burden or not? Res Dev Disabil. 2012 Mar-Apr;33(2):341-9. doi: 10.1016/j.ridd.2011.10.026. Epub 2011 Nov 25.
PubMed 22119679
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy Between Parents of Children With Spastic Diplegic Cerebral Palsy Who Use and Do Not Use Night Orthoses
- ClinicalTrials.gov ID
- NCT07846917
- Acronym / sponsor ID
- E-59394181-100-137245
- Conditions
- Cerebral Palsy, Sleep Disorders, Caregiver Burden
- Keywords
- Spastic Diplegic Cerebral Palsy, Night Orthosis, Sleep Quality, Caregiver Burden, Parental Stress, Parental Self-Efficacy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 29 Sep 2026 (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.
This observational study aims to compare sleep quality, caregiver burden, stress, and self-efficacy between parents of children with spastic diplegic cerebral palsy who use night orthoses and those who do not. Approximately 150 parents will be included and divided into two groups according to their children's night orthosis use. The study will investigate whether night orthosis use is associated with differences in parental sleep quality, caregiver burden, stress, and self-efficacy.
Detailed description
Children with spastic diplegic cerebral palsy may experience sleep disturbances that can affect their parents' sleep quality and caregiving responsibilities. Night orthoses are commonly used in the management of cerebral palsy; however, their relationship with parental sleep quality and psychosocial outcomes remains unclear.
This observational, comparative study will include approximately 150 parents of children with spastic diplegic cerebral palsy. Participants will be divided into two groups: parents of children who use night orthoses and parents of children who do not use night orthoses.
Parental sleep quality, caregiver burden, stress, and self-efficacy will be assessed using standardized questionnaires. The outcomes will be compared between the two groups to examine potential associations with night orthosis use.
The findings may contribute to a better understanding of the relationship between night orthosis use and parental well-being and may help inform family-centered rehabilitation approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents of Children Using Night Orthoses | – | –Parents of children with spastic diplegic cerebral palsy who regularly use night orthoses. Parental sleep quality, caregiver burden, perceived stress, and self-efficacy will be assessed. |
| Parents of Children Not Using Night Orthoses | – | –Parents of children with spastic diplegic cerebral palsy who do not use night orthoses. Parental sleep quality, caregiver burden, perceived stress, and self-efficacy will be assessed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 150 parents of children aged 6-15 years with spastic diplegic cerebral palsy will be included. Parents will be classified into two groups according to their children's existing night orthosis use. Parental sleep quality, caregiver burden, parenting stress, and self-efficacy will be compared between groups.
Key inclusion criteria (5 listed)
- Being the parent of a child aged 6-15 years diagnosed with spastic diplegic cerebral palsy.
- Being the child's primary caregiver.
- Having provided active care for at least 6 months.
- Being literate.
- Providing informed consent to participate in the study.
Key exclusion criteria (10 listed)
- Having a diagnosed severe psychiatric disorder.
- Regular use of medications affecting sleep patterns (e.g., sedatives).
- Having a severe chronic disease (e.g., advanced cardiac or renal disease).
- Having experienced a major acute stressor (e.g., bereavement or trauma) within the previous month.
- Having a primary neurological disorder directly affecting sleep.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: At baseline (single assessment)
Parental sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire evaluating sleep quality over the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A score greater than 5 indicates poor sleep quality.
Zarit Burden Interview
Time frame: At baseline (single assessment)
Caregiver burden will be assessed using the Zarit Burden Interview (ZBI), a 22-item self-report questionnaire evaluating the physical, emotional, social, and economic burden of caregiving. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 88. Higher scores indicate greater caregiver burden.
Parenting Stress Index-Short Form (PSI-SF)
Time frame: At baseline (single assessment).
Parenting stress will be assessed using the Parenting Stress Index-Short Form (PSI-SF), a 36-item questionnaire comprising three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Total scores range from 36 to 180, with higher scores indicating greater parenting stress.
Parental Self-Efficacy Scale
Time frame: At baseline (single assessment)
Parental self-efficacy will be assessed using the 17-item Parental Self-Efficacy Scale. The Turkish version will be used to evaluate parents' perceived confidence in their parenting abilities. Each item is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree), yielding a total score ranging from 17 to 119. Higher scores indicate greater parental self-efficacy and therefore a better outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 34265112Lang CP, Boucaut A, Guppy M, Johnston LM. Children with cerebral palsy: A cross-sectional study of their sleep and their caregiver's sleep quality, psychological health and well-being. Child Care Health Dev. 2021 Nov;47(6):859-868. doi: 10.1111/cch.12897. Epub 2021 Jul 26.
- Background: PubMed 22119679Mol EM, Monbaliu E, Ven M, Vergote M, Prinzie P. The use of night orthoses in cerebral palsy treatment: sleep disturbance in children and parental burden or not? Res Dev Disabil. 2012 Mar-Apr;33(2):341-9. doi: 10.1016/j.ridd.2011.10.026. Epub 2011 Nov 25.
- 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.
Süleyman Korkusuz, PhD principal investigator
Atılım 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 Sleep Disorders, run by Atılım University at 1 site in Turkey (Türkiye).
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 8 Oct 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Süleyman Korkusuz, PhD (+905388675480, suleyman.korkusuz@atilim.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: At baseline (single assessment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07846917, which also lists 2 linked publications.
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 8 Oct 2026.