Effect of High Frequency Chest Wall Oscillation on Pulmonary Functions in Children With Non-Cystic Fibrosis Bronchiectasis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume in 1 second (FEV1)
研究概览
简要总结
the study will concentrate on the effect of High Frequency Chest Wall Oscillation compared to conventional pulmonary physiotherapy on children with non cystic fibrosis bronchiectasis
详细描述
The purpose of this study is to evaluate the effect of using HFCWO intervention on pulmonary functions in children with bronchiectasis.
it hypothesized that Using HFCWO has no effect on pulmonary functions and hospital stay in children with bronchiectasis.
Children subjected to the inclusion criteria will be assigned randomly into two groups, control group and study group.
Does high frequency chest wall oscillation (HFCWO) have an effect in pulmonary functions in children with bronchiectasis? RCT study Control group Patients in this group will be 30 children who will be treated by conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life.
Study group This group will include 30 children who will use HFCWO for 20 minutes, in addition to 10 minutes of the same conventional program of physiotherapy given to the control group.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Children with no cystic fibrosis bronchiectasis
- •Both sexes
- •Their ages ranges from 6-12 years
- •After 48 hours of attack, if hemoptysis or fever not found
排除标准
- •• Osteoporosis (Calcium deficiency)
- •Bleeding tendency
- •Recent surgery of brain, eye, thoracic, or neck surgery
- •Pneumothorax
- •Cystic fibrosis bronchiectasis
- •Pulmonary embolism
- •Rib fracture
研究组 & 干预措施
children who will use HFCWO for 20 minutes, in addition to 10 minutes of the same conventional progr
This group will include 30 children who will use HFCWO for 20 minutes, in addition to 10 minutes of the same conventional program of physiotherapy given to the control group.
The frequency of treatment will be 5 sessions/week for three successive months for both groups for long term effect and daily for immediate effect.
干预措施: High Frequency Chest Wall Oscillation (Device)
children who will be treated by conventional physiotherapy program
Patients in this group will be 30 children who will be treated by conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life.
干预措施: conventional physiotherapy program directed towards improvement of pulmonary functions and quality of life. (Other)
结局指标
主要结局
Forced Expiratory Volume in 1 second (FEV1)
时间窗: Baseline and after 8 weeks of treatment
Change in FEV1 measured by spirometry according to ATS/ERS guidelines
Forced Vital Capacity (FVC)
时间窗: Baseline and after 6 months of treatment
Change in FVC measured by spirometry according to ATS/ERS guidelines
FEV1/FVC Ratio
时间窗: Baseline and after 6 months of treatment
Change in FEV1/FVC ratio measured by spirometry according to ATS/ERS guidelines
次要结局
- Six-Minute Walk Distance (6MWD)(Baseline and after 6 months of treatment)
研究者
Marwa El-kawy Ghait Mohamed
Assistant lecturer, Faculty of Physical Therapy Sphinx University
Sphinx university