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临床试验/NCT05229757
NCT05229757Unknown不适用

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

Hasan Kalyoncu University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年5月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
28
试验地点
1
主要终点
Beck Depression Scale (For family)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

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

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: 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.

干预措施: Family-based home exercise. (Other)

结局指标

主要结局

Beck Depression Scale (For family)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Ergun Kayiran

Msc, PT

Hasan Kalyoncu University

研究点 (1)

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