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Completed

NCT Number: NCT07168577

Sleep Quality and Caregiver Burden in Children With Cerebral Palsy

Cerebral palsy (CP) is a lifelong condition that affects movement and posture in children, often requiring continuous care from family members. Children with CP frequently experience sleep problems due to spasticity, pain, seizures, or behavioral difficulties. Poor sleep can negatively affect the child's health and development, as well as increase the physical and emotional burden on their caregivers.

This study aims to evaluate the sleep quality of children with CP and their primary caregivers, and to examine the relationship between caregiver burden and these sleep-related factors. The study will include children aged 2 to 18 years with a diagnosis of CP and their primary caregivers (parents or legal guardians).

Children's sleep patterns will be assessed using the Children's Sleep Habits Questionnaire (CSHQ). Their functional levels will be classified using the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), and Communication Function Classification System (CFCS). Caregivers' sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI), caregiver burden with the Zarit Burden Interview (ZBI), and psychological status with the Hospital Anxiety and Depression Scale (HADS).

By identifying how sleep problems are linked with caregiver burden and psychological health, this study may provide valuable insights for developing supportive intervention programs for both children with CP and their families.

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Key information

About this study

Cerebral palsy (CP) is the most common cause of motor disability in childhood and often requires long-term daily care provided by family members. Sleep disorders are highly prevalent in children with CP compared with typically developing peers and are frequently associated with spasticity, seizures, pain, and behavioral issues. Poor sleep may further compromise the child's functional capacity and quality of life. At the same time, caregivers of children with CP often face increased physical and psychological demands, including high levels of stress, anxiety, and depression, which may be exacerbated by poor sleep quality and increased caregiving burden.

Although prior studies have investigated these factors separately, there is limited research examining the combined relationship between child sleep quality, functional status, caregiver sleep quality, caregiver burden, and psychological health. A comprehensive evaluation of these interrelated aspects may help in identifying high-risk groups and developing supportive interventions for both children and caregivers.

This single-center, observational, cross-sectional study will be conducted in the outpatient Physical Medicine and Rehabilitation clinics of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. The study will recruit at least 100 child-caregiver pairs. Children aged 2-18 years with a confirmed diagnosis of CP and their primary caregivers (aged ≥18 years) will be included. Sampling will be based on convenience and voluntary participation.

Data collection will include standardized questionnaires and clinical classifications. For children, sleep quality will be assessed using the Children's Sleep Habits Questionnaire (CSHQ), while functional levels will be determined by the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), and Communication Function Classification System (CFCS). Spasticity will be evaluated with the Modified Ashworth Scale. For caregivers, sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), caregiver burden with the Zarit Burden Interview (ZBI), and psychological status with the Hospital Anxiety and Depression Scale (HADS).

All assessments will be performed by trained researchers through face-to-face interviews following standardized protocols. Data will be analyzed using descriptive statistics, correlation tests, and multivariable regression analyses to explore the associations between child sleep quality, caregiver sleep quality, caregiver burden, and psychological outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 2-18 years with a confirmed diagnosis of cerebral palsy
  • Primary caregiver (≥18 years, parent or legal guardian) responsible for the child's daily care
  • Ability to read and write in Turkish
  • Sufficient cognitive capacity to complete questionnaires and participate in interviews
  • Voluntary agreement of both the child's caregiver and participant to join the study

Exclusion criteria

  • Presence of severe comorbid neurological or metabolic disease in the child
  • Caregiver with a history of severe psychiatric disorder or cognitive impairment
  • Communication problems that prevent completion of questionnaires
  • Hospitalization within the last 3 months due to acute medical condition
  • Withdrawal of consent or incomplete questionnaires during the study

Treatment and study plan

Primary outcomes

  1. Child Sleep Quality Assessed by Children's Sleep Habits Questionnaire (CSHQ)

    Time frame: Day 1 (single assessment at baseline)

    Sleep quality of children with cerebral palsy will be assessed using the parent-reported Children's Sleep Habits Questionnaire (CSHQ), a validated scale measuring common sleep behaviors and problems in children.

  2. Caregiver Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Day 1 (single assessment at baseline)

    Sleep quality of caregivers will be measured using the Pittsburgh Sleep Quality Index (PSQI), which evaluates sleep patterns and disturbances over the previous month.

  3. Caregiver Burden Assessed by Zarit Burden Interview (ZBI)

    Time frame: Day 1 (single assessment at baseline)

    Caregiver burden will be assessed using the Zarit Burden Interview (ZBI), a validated questionnaire evaluating the impact of caregiving on emotional, physical, and social well-being.

Secondary outcomes

  1. Child Functional Level Assessed by Gross Motor Function Classification System (GMFCS)

    Time frame: Day 1 (single assessment at baseline)

    Functional motor levels of children with cerebral palsy will be classified according to the GMFCS, a standardized 5-level system describing gross motor function.

  2. Manual Ability Assessed by Manual Ability Classification System (MACS)

    Time frame: Day 1 (single assessment at baseline)

    Hand function and manual ability of children will be evaluated using the MACS, a validated classification system for children with cerebral palsy.

  3. Communication Function Assessed by Communication Function Classification System (CFCS)

    Time frame: Day 1 (single assessment at baseline)

    Communication ability of children will be assessed using the CFCS, which categorizes functional communication performance in daily life.

  4. Spasticity Assessed by Modified Ashworth Scale (MAS)

    Time frame: Day 1 (single assessment at baseline)

    Muscle spasticity will be measured using the Modified Ashworth Scale (MAS), a widely used clinical tool for grading resistance to passive movement.

  5. Caregiver Psychological Status Assessed by Hospital Anxiety and Depression Scale (HADS)

    Time frame: Day 1 (single assessment at baseline)

    Caregivers' psychological health will be evaluated using the HADS, a self-reported screening tool for symptoms of anxiety and depression.

Sponsors and collaborators

Lead sponsor

Selim Sezikli

Other Gov

Registry information

Official study title

Evaluation of Sleep Quality and Caregiver Burden in Children With Cerebral Palsy

Acronym: CP-SLEEP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2025
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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