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临床试验/NCT06640686
NCT06640686尚未招募不适用

The Effects of Inspiratory Muscle Training on Respiratory Parameters, Trunk Control, Walking, and Functional Independence in Children With Cerebral Palsy

Istanbul University - Cerrahpasa (IUC)0 个研究点目标入组 36 人开始时间: 2024年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
36
主要终点
2 minutes walking test

研究概览

简要总结

Cerebral palsy (CP) is characterized by permanent or variable sensory-motor function impairments resulting from developmental anomalies or damage to the brain. Spasticity, dystonia, postural disorders, and weakened movement patterns can hinder the development of the respiratory system in children with CP. As the severity of postural disorders increases in children with CP, inadequate or improper use of respiratory muscles and insufficient ventilation reduce the mobility of the thoracic cage. The aim of study is to investigate the effects of respiratory muscle training on respiratory parameters, trunk control, walking, and functional independence in children with CP.

详细描述

In this prospective randomized controlled study, participants will be divided into two groups: the Inspiratory Muscle Training (IMT) group and the control group. The IMT group will receive IMT in addition to the traditional physical therapy program, while the control group will only receive the traditional physical therapy program. Respiratory muscle strength, respiratory functions, chest expansion, trunk control, walking speed and endurance, and functional independence will be assessed before and after the training.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants will be blind to their group and outcomes assessor will be blind to groups.

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged between 4 and 12 years
  • Classified as levels 1, 2, and 3 according to the Gross Motor Function Classification System (GMFCS)
  • Diagnosed with spastic diplegia and/or hemiplegic cerebral palsy
  • Ability to cooperate during the exercises

排除标准

  • Presence of acute or chronic respiratory diseases
  • Presence of acute medical conditions
  • History of active epilepsy
  • Scoliosis with a Cobb angle greater than 30 degrees
  • Presence of chest deformities
  • Severe visual and hearing impairments

结局指标

主要结局

2 minutes walking test

时间窗: 6 months

gait endurance will assess with 2 minutes walking test.

trunk control mesurement scale

时间窗: 6 months

trunk control will assess with Trunk Control Measurement Scale.

10 m walking test

时间窗: 6 months

gait speed will assess with 10 meter walking test

PP Check device

时间窗: 6 months

respiratory muscle strength will assess with device that called 'RP Check'.

spirometer

时间窗: 6 months

respiratory function test will be assess with spirometer.

WeeFIM scale

时间窗: 6 months

functional independence will assess with WeeFIM scale.

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gamze Aydin

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

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