Functionality and Family Characteristics in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

The Effect of Family Characteristics on the Functional Level of Children With Cerebral Palsy of the Spastic Type With Walking Ability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06439446
• Other study ID #: KAEU-T.ATAHAN-004
• Status: Completed
• Start date: June 6, 2023
• Est. completion date: May 25, 2024

Study information

• Verified date: May 2024
• Source: Kirsehir Ahi Evran Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study was to investigate the effect of family characteristics on functional level in children with Spastic Type Cerebral Palsy who are able to walk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 25, 2024
• Est. primary completion date: May 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

Inclusion Criteria:

• Diagnosed with hemiparetic and diparetic type CP

• Between the ages of 5-15

• GMFCS level I, II and III

• Volunteer individuals were included.

Exclusion Criteria:

• Having undergone a surgical operation within the last year,

• Having contracture in the lower extremity,

• Having had a fracture in the lower extremity in the last 6 months,

• Botulinum Toxin A (BTX-A) administered in the last 6 months

• Patients with cognitive, visual or hearing impairments that would prevent communication with their peers and siblings were excluded from the study.

Related Conditions & MeSH terms

• Cerebral Palsy
• Family Characteristics

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	Gross Motor Function Level	Gross motor function level was measured with Gross Motor Function Measure-66 (GMFM-66). GMFM-66 is a 66-item test developed to measure gross motor skills in children with cerebral palsy and can be evaluated in 5 different categories, including reaching and rolling, sitting, crawling and crawling, standing, walking, running and jumping. It is a 4-point Likert type scale. Higher scores on the test indicate higher gross motor skills.	36 week
Primary	Parents' Quality of Life	Parents' self-reported quality of life functions such as physical, emotional, social, and cognitive were assessed with The PedsQL Family Impact Module. Total score range is 0-100. Higher scores on the scale indicate less anxiety.	36 week
Secondary	Gross Motor Function Classification	Gross motor functional classification was evaluated with the Gross Motor Function Classification System (GMFCS). GMFCS classifies children with Cerebral Palsy into 5 levels (1-5) based on their motor skills, functional abilities, assistive technologies, and wheelchair needs.	36 week
Secondary	Sociodemographic Form	Characteristic information about the family, such as the family's average monthly income, the number of people living in the family, and the region in which the family lived, was collected.	36 week