Effects of Inspiratory Muscle Training on Respiratory Functions, Trunk Control, Activities of Daily Living, Functional Exercise Capacity and Quality of Life in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Timed Up and Go Test
研究概览
简要总结
Even if cerebral palsy not directly effect respiratory system, impairment of nervous and muscle systems, because of the brain damage, may cause respiratory functions impairment. In literature, it has been showed that children with cerebral palsy have decreased respiratory muscle strength and associated with trunk control, quality of life and respiratory functions. But, there is no study in literature that aims to increase respiratory muscle strength in these children. Hence, the aim of this study is to investigate effects of inspiratory muscle training on respiratory functions, trunk control, activities of daily living, functional exercise capacity and quality of life in children with cerebral palsy.
详细描述
A convenience of children with hemiparetic and diplegia CP, 7-14 years, is going to recruited from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation. Patients will randomly allocate to either a treatment group or control group. The treatment group will receive inspiratory muscle training at 30-40% of maximal mouth pressure, the control group will receive sham inspiratory muscle training at a fixed work load, 5% of maximal mouth pressure. Groups are going to train for a total of 30 min/d, 7 days/week, for 6 weeks. Before and after treatment, every each of patients pulmonary function test will be evaluated with using spirometry, respiratory muscle strength using with electronic mouth pressure device, trunk control with using trunk control measurement scale, activities of daily living using with Pediatric Evaluation of Disability Inventory (PEDI), functional exercise capacity usin with six minute walk test (6MWT) and quality of life using with Cerebral Palsy Quality of Life Questionnaire (CPQOL).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 7-14 years
- •Diagnosed to spastic cerebral palsy
- •Gross Motor Function Classification System levels I or II.
- •Have no earlier interventions in the form of orthopaedic surgery or injection with botulinum toxin type A in the 6 month prior to baseline assessments
- •Child are able to demonstrate sufficient co-operation and cognitive understanding participating
排除标准
- •Active medical condition impairment (pneumonia etc.)
- •Do not accommodate the study
- •Do not want to attempt the study
研究组 & 干预措施
Treatment Group
The treatment group received Inspiratory muscle training (IMT) at 40% of maximal mouth pressure (PImax) by using Threshold IMT and training loads were adjusted to maintain 40% of the PImax weekly. The PImax was measured at supervised sessions each week, and 40% of the measured value was determined as the new training work load.
干预措施: Threshold (IMT) (Device)
Control Group
The control group received sham Inspiratory muscle training (IMT) at a fixed work load, 5% of PImax by using Threshold IMT.
干预措施: Threshold (IMT) (Device)
结局指标
主要结局
Timed Up and Go Test
时间窗: 6 weeks
this is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair and sit down. During the test, the child is expected to wear their regular footwear and use any mobility aids that they would normally require.
次要结局
- Activities of daily living using with Pediatric Evaluation of Disability Inventory(6 weeks)
- Pulmonary Function Test(6 weeks)
- Respiratory muscle strength(6 weeks)
- Functional exercise capacity(6 weeks)
- Change in trunk control over time assessed with Trunk Control Measurement Scale(6 weeks)