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CompletedNCT06443398Updated Oct 1, 2024

Spine of Caregivers of Children with Cerebral Palsy

An observational study in Cerebral Palsy and Spine Deformity, sponsored by Kirsehir Ahi Evran Universitesi. Completed at 1 site in Turkey. Open to participants aged 25 Years to 54 Years. Per ClinicalTrials.gov, last updated 2024-10-01.

Sponsored by Kirsehir Ahi Evran Universitesi · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
164
Ages
25 Years to 54 Years
Sex
All
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Study summary

The purpose of this study was to assess pain (rest, activity, and night pain using the Visual Analog Scale), disability (neck using the Neck Disability Index; lumbar using the Oswestry Disability Index), and curvature (cervical, thoracic, and lumbar using the Spinal Mouse) in primary caregivers of children with cerebral palsy.

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Conditions studied

  • Cerebral Palsy
  • Spine Deformity

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Keywords

  • Primary Caregivers
  • Pain
  • Disability
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's enrollment of 164 is above the median of 63 across 455 observational studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Kirsehir Ahi Evran Universitesi is the lead sponsor of 133 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 54 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

It was conducted with caregivers of children with Cerebral Palsy who were receiving physiotherapy at Kırşehir Training and Research Hospital Physical Therapy and Rehabilitation Center and who met the exclusion-inclusion criteria.

Inclusion criteria

  • Primary caregiver between the ages of 25-54
  • Has a child diagnosed with Cerebral Palsy between the ages of 0-18
  • Does not have inflammatory pain
  • Without pain originating from abdominal-pelvic organs
  • Volunteer caregivers were included

Exclusion criteria

Exclusion Criteria:

  • Having acute fracture and malignancy
  • Had a surgical operation (related to spine disorders)
  • Having a care burden for more than one disabled individual
  • Caregivers with chronic illnesses (such as neurological, psychological disorders) were excluded
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
164 participants (actual)
Patient registry
No

Groups and cohorts

  • Control Group

    Primary caregivers with healthy children between the ages of 0-18 were included.

    Other: There is no intervention in the study

  • Study Group

    Primary caregivers who had a child diagnosed with Cerebral Palsy between the ages of 0-18 and met the inclusion criteria were included.

    Other: There is no intervention in the study

Interventions

  • OtherThere is no intervention in the study

    There is no intervention in the study

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What researchers measure

Primary outcomes

  1. Life Quality

    Parents' quality of life was measured using the Nottingham Health Profile. The scale has two parts. 0 represents the best health status, 100 the worst. Score on the scale and health status have an inverse relationship. As the score increases, the health status deteriorates.

    Time frame: 16 week

  2. Disability

    Functional problems related to the neck were assessed using the Neck Disability Index. The scale has 10 items. There are 6 options in each item and each option is scored between 0 and 5 depending on the severity of the limitation. Although the total score of the survey varies between 0 and 50, a higher score indicates an increase in limitation.

    Time frame: 16 week

  3. Disability

    Oswestry Disability Index was used to determine the degree of disability. The scale consists of a total of 10 items measuring the severity of pain, personal care, lifting, walking, sitting, standing, social life, sleeping, travel and pain degree. Each item is rated between 0-5. As the total score increases, the disability level increases. The maximum score is 50 points; Between 31 and 50 points is considered severe, between 11 and 30 points is considered moderate, and between 1 and 10 points is considered mild.

    Time frame: 16 week

  4. Spine

    Spine evaluation was performed with a spinal mouse device. The device is a computer-aided electromagnetic device that can be held by hand and used to measure spinal mobility in various postures.

    Time frame: 16 week

Secondary outcomes

  1. Socio-demographic Form

    Sociodemographic information of the caregivers, such as name, surname, age, gender, height, weight, BMI, and educational status, were recorded.

    Time frame: 16 week

  2. Pain Intensity

    The pain intensity of the patients was measured using the Visual Analogue Scale. The pain intensity score ranges from 0 to 10. An increase in the score indicates an increase in pain; a decrease in the score indicates a decrease in pain.

    Time frame: 16 week

  3. Gross Motor Function Classification

    Gross Motor Function Classification System (Children with Cerebral Palsy are classified in 5 levels (1-5) according to their motor skills, functional abilities, assistive technology and wheelchair requirements)

    Time frame: 16 week

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Study locations

1 site
  • Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center
    Kırşehir, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06443398
Lead sponsor
Kirsehir Ahi Evran Universitesi
Responsible party
Atahan TURHAN (Dr. Lecturer, Kirsehir Ahi Evran Universitesi) — Principal investigator
First posted
Jun 5, 2024
Start date
Jan 31, 2024
Primary completion
Sep 20, 2024
Completion
Sep 25, 2024
Last update
Oct 1, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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