The Effect of Family Education on Functional Level, Activity Level and Families in Children With Cerebral Palsy

Children With Cerebral Palsy Clinical Trial

Official title:

The Effect of Family Education on Functional Level, Activity Level and Families in Children With Cerebral Palsy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05229757
• Other study ID #: 2021/048
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: February 2022
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The activity status of children with cerebral palsy between the ages of 3 and 18 who participated in the physiotherapy program in special education institutions throughout the province of Gaziantep was evaluated. The effect of the family education to be given on the activity status of the children and the psychosocial status of the families was investigated.

The individuals included in the study were divided into two groups as patient and control. In the beginning, the scales used to determine the activity status and the scales to determine the depression status of their families were applied in order to determine the status of both groups. Children with cerebral palsy in the patient group received treatment in a special education and rehabilitation center two days a week for 8 weeks. Individuals in the control group were followed up with a home program. After 8 weeks of treatment, the same tests were repeated and it was examined whether the family education provided made a difference in children with cerebral palsy and their parents.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: April 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• Be in the age range of 3-18 years.

• Getting a diagnosis of cerebral palsy.

• Agree to participate in the study.

Exclusion Criteria:

• If the child interrupts supportive education for any reason,

• Failure of the family to ensure continuity in participation

Related Conditions & MeSH terms

• Cerebral Palsy
• Children With Cerebral Palsy

Intervention

Other:
• Physiotherapy and rehabilitation treatment in a special education and rehabilitation center.
Routine physiotherapy and rehabilitation practice was performed 2 days a week for 8 weeks in the special education and rehabilitation center.
• Family-based home exercise.
Home exercise was applied by the families every day of the week for 8 weeks.

Locations

Country	Name	City	State
Turkey	Hasan Kalyoncu University	Gaziantep	Sahinbey

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abilhand Kids (For patients)	It is a questionnaire consisting of 21 questions designed to test children's manual abilities. The applicability of the items by the child is evaluated in 3 steps as impossible, easy and difficult.	Change from Baseline Abilhand Kids at 8 weeks.
Primary	GMFM 66 (For patients)	Gross motor function assessment is a computerized test consisting of 66 questions. Evaluates the sub-titles as Reaching-Rolling, Sitting, Standing and running-Jumping.	Change from Baseline GMFM 66 at 8 weeks.
Primary	PEDI (For patients)	It is a scale that evaluates the functional skills of the child and the help and manner of the caregiver, in which each part is evaluated separately as self-care, mobility and social function items.	Change from Baseline PEDI at 8 weeks.
Primary	Beck Depression Scale (For family)	It is a survey aiming to reach the result by scoring between 0 and 3 with 21 questions. According to the total score, it is divided into 4 groups as minimal, mild, moderate and severe depression.	Change from Baseline Beck Depression Scale at 8 weeks.
Primary	IPFAM (For family)	The family impact scale asks for answers in 4 categories: I strongly disagree (4 points), disagree (3 points), agree (2 points), completely agree (1 point) in 27 questions. Makes classification according to the total score.	Change from Baseline IPFAM at 8 weeks.