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临床试验/NCT05518370
NCT05518370已完成不适用

The Effect of Hippotherapy Simulator on Sitting Balance, Trunk Control and Upper Extremity Skills in Cerebral Palsy

Gaziantep Islam Science and Technology University2 个研究点 分布在 2 个国家目标入组 32 人开始时间: 2022年8月26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
32
试验地点
2
主要终点
Manuel ability classification system (MACS)

研究概览

简要总结

Hippotherapy simulators imitate the passive movements of the horse, producing simple movements similar to those of the horse. Hippotherapy simulators are intended to improve sitting balance, postural control and trunk balance.

The aim of this study was to research the therapeutic effects of hippotherapy simulator on sitting balance, trunk control and upper extremity skills in individuals with Cerebral Palsy (CP).

详细描述

Spastic CP will be participate the study between the ages of 4 and 18 years. Children's classified with GMFCS and MACS.

The eligible participants will be allocated two groups, including hippotherapy simulator training group and traditional physiotherapy control group. All the assessments will be performed before and after the training in the 8-week training groups.

The control group individuals will be given a traditional physiotherapy two days per week for a total of 8 weeks (traditional physiotherapy session will last 45 minutes). Hippotherapy simulator training group will receive a traditional physiotherapy and hippotherapy simulator training, two days a week for a total of 8 weeks (30 minutes traditional physiotherapy session+15 minutes hippotherapy simulator training). All sessions will be performed in the clinic with the specialist physiotherapist.

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 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Spastic Cerebral Palsy voluntary participation
  • Age between 4-18 years,
  • GMFCS Level I-II-III
  • MACS Level I-II-III
  • Have the ability to sit upright with support

排除标准

  • Not voluntary to participate in the research,
  • Botox in the last 6 months
  • Hip or spine surgeries in the last 6 months

结局指标

主要结局

Manuel ability classification system (MACS)

时间窗: At Baseline

This is a classification system based on the grasping and releasing objects in daily life, and how they use their hands while holding objects. It is classify the hand skills of children with CP between the ages of 4-18.Children with CP are classified in five levels with MACS. The higher level indicates worse hand function

Change from Baseline Gross Motor Function Measure-88 at 8 weeks

时间窗: Change from Baseline at 8 weeks

It is used to show gross motor functions and changes in these functions. It consists of five main sections. Each section can be used by calculating separately within itself. The total score ranges from 0 to 100, with a high score indicating better function.

Change from Baseline Trunk Control Measurement Scale at 8 weeks

时间窗: Change from Baseline at 8 weeks

This scale consists of two main parts as dynamic and static sitting balance. The scale consists of 15 questions. The scoring of the items is 0, 1, 2 or 3. The total score ranges from 0 to 58, with a high score indicating better trunk control.

Change from Baseline ABILHAND-Kids at 8 weeks

时间窗: Change from Baseline at 8 weeks

Abilhand Kids evaluates manual ability in children with upper extremity disorders. It consists of 21 items and confirmed in CP. The lowest score that can be obtained from the scale is 21 and the highest score is 63. It can be stated that higher scores correspond to more difficulty in activities.

Change from Baseline The Jebsen Taylor Hand Function Test at 8 weeks

时间窗: Change from Baseline at 8 weeks

The Jebsen Taylor Hand Function Test (JTHFT) will be used to evaluate hand function in daily life. Both hands are tested separately. The time for all activities is recorded with a stopwatch. Higher duration indicates worse hand function.

Gross Motor Function Classification System (GMFCS)

时间窗: At Baseline

Assessing functional level and motor function. Gross motor functions of children with CP are classified in five levels with GMFCS. This is a classification system based on the child's self-initiated movements with emphasis on sitting, displacement and mobility.

Change from Baseline Pediatric Evaluation of Disability Inventory at 8 weeks

时间窗: Change from Baseline at 8 weeks

The Pediatric Evaluation of Disability Inventory (PEDI) is designed for the functional evaluation of children with special needs. This will be used to evaluate functional ability and performance. 0: can not do, 1: can do in the form of scoring is done. At the end of the evaluation, the points of the related section are collected. Higher score indicates a better level of functional independence.

次要结局

未报告次要终点

研究者

发起方
Gaziantep Islam Science and Technology University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Demet GÖZAÇAN KARABULUT

Assistant Professor

Gaziantep Islam Science and Technology University

研究点 (2)

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