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Clinical Trials/NCT05229757
NCT05229757UnknownNot Applicable

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

Hasan Kalyoncu University1 site in 1 country28 target enrollmentStarted: May 19, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
28
Locations
1
Primary Endpoint
Beck Depression Scale (For family)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Masking Description

The individuals included in the study and their families were not informed about which group they belonged to.

Eligibility Criteria

Ages
3 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Study Group

Experimental

Children with cerebral palsy in the patient group received treatment in a special education and rehabilitation center two days a week for 8 weeks.

Intervention: Physiotherapy and rehabilitation treatment in a special education and rehabilitation center. (Other)

Control Group

Active Comparator

Individuals in the control group were followed with a home program for 8 weeks.

Intervention: Family-based home exercise. (Other)

Outcomes

Primary Outcomes

Beck Depression Scale (For family)

Time Frame: Change from Baseline Beck Depression Scale at 8 weeks.

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)

Time Frame: Change from Baseline IPFAM at 8 weeks.

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.

PEDI (For patients)

Time Frame: Change from Baseline PEDI at 8 weeks.

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.

Abilhand Kids (For patients)

Time Frame: Change from Baseline Abilhand Kids at 8 weeks.

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)

Time Frame: Change from Baseline GMFM 66 at 8 weeks.

Gross motor function assessment is a computerized test consisting of 66 questions. Evaluates the sub-titles as Reaching-Rolling, Sitting, Standing and running-Jumping.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hasan Kalyoncu University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mehmet Ergun Kayiran

Msc, PT

Hasan Kalyoncu University

Study Sites (1)

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