Spine of Caregivers of Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443398
• Other study ID #: KAEU-T.ATAHAN-005
• Status: Recruiting
• Start date: January 31, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Kirsehir Ahi Evran Universitesi
• Contact: Atahan Turhan, PhD
• Phone: +90 554 571 72 91
• Email: atahanturhan[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 127
• Est. completion date: June 30, 2024
• Est. primary completion date: June 1, 2024
• Gender: All
• Age group: 25 Years to 54 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Spine Deformity

Locations

Country	Name	City	State
Turkey	Kirsehir Ahi Evran University Physical Therapy and Rehabilitation Center	Kirsehir

Sponsors (1)

Lead Sponsor	Collaborator
Kirsehir Ahi Evran Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Socio-demographic Form	Sociodemographic information of the caregivers, such as name, surname, age, gender, height, weight, BMI, and educational status, were recorded.	16 week
Secondary	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
Secondary	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