Spine of Caregivers of Children with Cerebral Palsy

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

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 Overview

• Status: Completed
• Conditions: Cerebral Palsy; Spine Deformity
• Intervention / Treatment: Other: There is no intervention in the study

• Study Type: Observational
• Enrollment (Actual): 164

Contacts and Locations

Study Locations

• Turkey
  • Kırşehir, Turkey
    • Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group; Primary caregivers with healthy children between the ages of 0-18 were included.	Other: There is no intervention in the study; 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; There is no intervention in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 week
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.	16 week
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.	16 week
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.	16 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socio-demographic Form	Sociodemographic information of the caregivers, such as name, surname, age, gender, height, weight, BMI, and educational status, were recorded.	16 week
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.	16 week
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)	16 week

Collaborators and Investigators

• Sponsor: Kirsehir Ahi Evran Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Actual): September 20, 2024
• Study Completion (Actual): September 25, 2024

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Disability; Primary Caregivers
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: KAEU-T.ATAHAN-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No