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临床试验/NCT06003868
NCT06003868已完成不适用

Investigation of the Effect of Hippotherapy Simulator on Balance and Walking in Children With Spastic Diplegia Cerebral Palsy

Uskudar University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9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
40
试验地点
1
主要终点
Pediatric Berg Balance Scale

研究概览

简要总结

The aim of the study is to examine the effect of hippotherapy simulator on trunk control, balance and gait in children with spastic diplegia cerebral palsy and its relationship with quality of life.

详细描述

Patients diagnosed with spastic diplegia cerebral palsy in the study; It will be classified according to Gross Motor Function Classification System (KMFSS). The Trunk Control Measurement Scale will be used to assess trunk control. Pediatric Berg Balance Scale will be used to assess balance. The 1 Minute Walk Test and the Timed Get Up and Go test will be used to assess walking. The WEEFIM scale will be used to assess quality of life. The study sample will be divided into two groups. The first group will receive 45 minutes of conventional physical therapy. In addition to 45 minutes of physical therapy, the other group will receive 15 minutes of hippotherapy simulator. The results will be compared at the beginning and end of the study.

Then, individuals will be divided into two groups with a simple randomized method. Traditional physical therapy will be applied to the control group for 45 minutes, 2 days a week, for 8 weeks. In addition to traditional physical therapy, 15 minutes of therapy training with a hippotherapy device will be applied to the experimental group. Evaluation tests will be repeated at the beginning and end of the study. Pre- and post-intervention data were statistically analyzed and compared.

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
Single (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diplegic Cerebral Palsy between the ages of 4 and 16
  • Levels 1,2 and 3 according to KMFSS
  • Have not had botox or surgery in the last 6 months
  • Able to perceive simple commands
  • Patients who can sit in the hippotherapy simulator will be included.

排除标准

  • With hip dislocation
  • Those with hearing or visual disabilities
  • Those who do not want to be involved in the study
  • Adductor spasticity is stage 3 and above according to the ashworth spasticity scale.
  • With upper extremity amputation

结局指标

主要结局

Pediatric Berg Balance Scale

时间窗: 10 weeks

Berg Balance Scale was designed for children to evaluate functions in activities of daily living. version. The scale consists of 14 assessments and each section is scored between 0-4; The highest possible score is 56.

Trunk Control Measurement Scale

时间窗: 10 weeks

For this reason, the scale consists of two parts: Static Sitting Balance (SSB) and Dynamic Sitting Balance (DSB). The DSB section also consists of two sub-parameters as selective motion control and dynamic reach. While the static sitting balance subscale evaluates static trunk control during lower and upper extremity movements, the selective motion control subscale evaluates selective trunk movements in three planes (flexion/extension, rotation, and lateral flexion). The dynamic reach subscale evaluates performance during reaching tasks that require active trunk movement. The scale consists of 15 items in total (subscales 5, 7 and 3 items, respectively). Items are scored on a 2, 3, and 4-point ordinal scale and are administered bilaterally when clinically significant. While the total score of the scale varies between 0-58 points, higher scores indicate a better performance.

1 Minute Walk Test

时间窗: 10 weeks

First, the child puts on his own clothes and shoes. He is allowed to use his splints and suitable walking aid. At least 5 minutes before starting the test. He is allowed to rest and then brought to the starting point of the path he will walk. When the command is given, it is said to start walking as fast as possible for 1 minute. It is also reported that he is not allowed to run. The distance is then calculated.

Timed get up and go test

时间窗: 10 weeks

It is a test used to measure mobility and assesses walking speed, postural control, functional mobility and balance. The Timed Get Up and Go Test measures the time it takes for a person to get up from an arm-supported chair, turn by walking 3 m, and walk back to the chair, then sit down. The time it takes to get up from the chair and sit back on the chair is recorded.

Functional independence measurement for children (WEEFIM)

时间窗: 10 weeks

It was developed to assess the level of functional independence of children with a physical disability and consists of three main categories and a total of 18 questions. A total of 18 questions under the heading of self-care, mobility and cognitive function categories are scored between 1 and 7. According to this; While performing the function to be evaluated, the child with a physical disability gets 1 point if he/she does it completely with assistance, and 7 points if he/she does it completely independently. The lowest score that the child can get from the scale is 18, and the highest score is 126.

次要结局

未报告次要终点

研究者

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

Dr. Öğr. Üyesi Ömer Şevgin

assistant professor

Uskudar University

研究点 (1)

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