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Clinical Trials/NCT06443398
NCT06443398CompletedNot Applicable

Evaluation of the Spine of Primary Caregivers of Children with Cerebral Palsy

Kirsehir Ahi Evran Universitesi1 site in 1 country164 target enrollmentStarted: January 31, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
164
Locations
1
Primary Endpoint
Disability

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
25 Years to 54 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • •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

Outcomes

Primary Outcomes

Disability

Time Frame: 16 week

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.

Life Quality

Time Frame: 16 week

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.

Spine

Time Frame: 16 week

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.

Secondary Outcomes

  • Socio-demographic Form(16 week)
  • Gross Motor Function Classification(16 week)
  • Pain Intensity(16 week)

Investigators

Sponsor
Kirsehir Ahi Evran Universitesi
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Atahan TURHAN

Dr. Lecturer

Kirsehir Ahi Evran Universitesi

Study Sites (1)

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