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临床试验/NCT05966428
NCT05966428已完成不适用

The Affect of Sensory Integration Therapy and Conventional Exercise Therapy on Spasticity, Balance and Motor Function With Spastic Diplegic Cerebral Palsy

Kirsehir Ahi Evran Universitesi2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Muscle Tone

研究概览

简要总结

This intervention study was planned to investigate the effects of Sensory Integration Therapy that added to the conventional therapy program on spasticity, balance, motor function and functional independency levels of children with spastic diplegic cerebral palsy

详细描述

Cerebral Palsy is a disease that can cause motor skill and posture disorders due to a non-progressive lesion in the brain that has not yet completed its development. Cerebral palsy is among the most common causes of disability in childhood. There are many conditions that can cause Cerebral Palsy. Risk groups that cause brain damage can be considered as prenatal, perinatal and postnatal risk factors.The lesion that occurs in the central nervous system in patients with Cerebral Palsy causes some problems in the musculoskeletal system, nervous system and sensory systems. In addition to these problems, depending on the level of the lesion, posture, movement disorders and balance problems occur in individuals with Cerebral Palsy. Sensory integration therapy is a neurological process of perceiving, interpreting and organizing our senses for an effective integration of the individual with the environment. When the literature is examined, the number of studies investigating the effect of sensory integration program in children with spastic diplegic type Cerebral Palsy is insufficient. The aim of this study is to investigate the effect of sensory integration therapy on spasticity, balance and motor function in children with spastic diplegic type Cerebral Palsy and to provide the data obtained at the end of the study to the literature both theoretically and practically.

The hypothesis of the study is:

  • Sensory integration program reduces spasticity in children with spastic diplegic type Cerebral Palsy.
  • Sensory integration program increases balance in children with spastic diplegic type Cerebral Palsy.
  • Sensory integration program increases motor function in children with spastic diplegic type Cerebral Palsy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 4-17
  • Diagnosed with spastic diplegic type Cerebral Palsy
  • Having Gross Motor Function Classification System levels I and II

排除标准

  • Children who underwent phenol and botulinum toxin-a injections in the last 6 months before the study
  • Had a previous surgical operation, and had a cardiopulmonary disease that could prevent exercise
  • Children with communication, hearing and vision problems

结局指标

主要结局

Muscle Tone

时间窗: 8 week

Modified Ashworth Scale (The muscle tone evaluated on this scale is graded between 0 and 4 and is scored between 0 and 5)

Functional Balance

时间窗: 8 week

Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function.)

Gross Motor Function

时间窗: 8 week

Gross Motor Function Measure (The scores are in 4 categories as "0" not starting the activity, starting independently "1", partially completing "2" and independently completing "3".)

Functional Independence

时间窗: 8 week

Functional Independence Measure for Children (These items are scored from 1 to 7 according to whether they received help while performing each function)

次要结局

  • Gross Motor Function Classification(8 week)

研究者

发起方
Kirsehir Ahi Evran Universitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Atahan TURHAN

Principal Investigator: Atahan Turhan, PhD

Kirsehir Ahi Evran Universitesi

研究点 (2)

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