The Effect of Family Education on Functional Level, Activity Level and Families in Children With Cerebral Palsy
Primary Purpose
Children With Cerebral Palsy
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physiotherapy and rehabilitation treatment in a special education and rehabilitation center.
Family-based home exercise.
Sponsored by
About this trial
This is an interventional treatment trial for Children With Cerebral Palsy
Eligibility Criteria
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
Sites / Locations
- Hasan Kalyoncu University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study Group
Control Group
Arm Description
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 with a home program for 8 weeks.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05229757
First Posted
January 13, 2022
Last Updated
February 7, 2022
Sponsor
Hasan Kalyoncu University
1. Study Identification
Unique Protocol Identification Number
NCT05229757
Brief Title
The Effect of Family Education on Functional Level, Activity Level and Families in Children With Cerebral Palsy
Official Title
The Effect of Family Education on Functional Level, Activity Level and Families in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children With Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
The individuals included in the study and their families were not informed about which group they belonged to.
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Children with cerebral palsy in the patient group received treatment in a special education and rehabilitation center two days a week for 8 weeks.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Individuals in the control group were followed with a home program for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Physiotherapy and rehabilitation treatment in a special education and rehabilitation center.
Intervention Description
Routine physiotherapy and rehabilitation practice was performed 2 days a week for 8 weeks in the special education and rehabilitation center.
Intervention Type
Other
Intervention Name(s)
Family-based home exercise.
Intervention Description
Home exercise was applied by the families every day of the week for 8 weeks.
Primary Outcome Measure Information:
Title
Abilhand Kids (For patients)
Description
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.
Time Frame
Change from Baseline Abilhand Kids at 8 weeks.
Title
GMFM 66 (For patients)
Description
Gross motor function assessment is a computerized test consisting of 66 questions. Evaluates the sub-titles as Reaching-Rolling, Sitting, Standing and running-Jumping.
Time Frame
Change from Baseline GMFM 66 at 8 weeks.
Title
PEDI (For patients)
Description
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.
Time Frame
Change from Baseline PEDI at 8 weeks.
Title
Beck Depression Scale (For family)
Description
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.
Time Frame
Change from Baseline Beck Depression Scale at 8 weeks.
Title
IPFAM (For family)
Description
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.
Time Frame
Change from Baseline IPFAM at 8 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hasan Kalyoncu University
City
Gaziantep
State/Province
Şahinbey
ZIP/Postal Code
27000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Family Education on Functional Level, Activity Level and Families in Children With Cerebral Palsy
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