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

NCT05229757 | Unknown DMC

• 1 other identifier: 2021/048
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Children With Cerebral Palsy

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

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.

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

Control Group

ACTIVE COMPARATOR

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

Other: Family-based home exercise.

Interventions

Physiotherapy and rehabilitation treatment in a special education and rehabilitation center. OTHER

Routine physiotherapy and rehabilitation practice was performed 2 days a week for 8 weeks in the special education and rehabilitation center.

Study Group

Family-based home exercise. OTHER

Home exercise was applied by the families every day of the week for 8 weeks.

Control Group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be in the age range of 3-18 years.
• Getting a diagnosis of cerebral palsy.
• Agree to participate in the study.

You may not qualify if:

• If the child interrupts supportive education for any reason,
• Failure of the family to ensure continuity in participation

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Şahinbey, 27000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Physical Therapy Modalities; Rehabilitation; Rehabilitation Centers

Intervention Hierarchy (Ancestors)

Therapeutics; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services; Health Facilities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The individuals included in the study and their families were not informed about which group they belonged to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc, PT

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 8, 2022
• Study Start: May 19, 2021
• Primary Completion: December 31, 2021
• Study Completion: April 30, 2022
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)