Incentive Spirometer Training and Oropharyngeal Motor Training for Pulmonary Dysfunction in Spastic Diplegic Children
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- forced vital capacity (FVC)
研究概览
简要总结
Purpose of the study to determine the impact of incentive spirometer training and the oropharyngeal motor training or the combination of both for pulmonary dysfunction in spastic diplegic children
详细描述
This is a prospective randomized controlled clinical trial, conducted at Kafr El sheikh Hospital.
- Forty-eight children of both genders.
- The study will include children (age 3-7 years) post selective pulmonary dysfunction.
- Children meeting the inclusion criteria will be randomly assigned to one of three groups:
- first Experimental Group: children in this group will receive incentive spirometer training.
- second Experimental Group:children in this group will receive oropharyngeal motor training. .
- third experimental Group: Patients in this group will receive combination of incentive spirometer training and oropharyngeal motor training
- Randomization will be achieved using computer-generated random numbers to ensure an equal distribution of patients between the two groups.
Conditions: Cerebral Palsy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the children with spastic CP between the age from 3 to 7 years old.
- •Level I to IV on the gross motor function classification system (GMFCS) , who have the partial ability to maintain antigravity head and trunk postures.
- •Cognitive and cooperative function allowing pulmonary function measurements.
- •No history of psychiatric or neurological disorders rather than cp.
排除标准
- •Any uncontrolled clinically significant medical conditions such as coexistent cardiac disease or respiratory disease
- •Children with cognitive impairment who are unable to comply with the protocol required procedure
- •Children who are taking medications that can affect respiratory function
- •Children with presence or history of tracheostomy
研究组 & 干预措施
Group A : Will include 16 spastic diplegic Children suffer from pulmonary dysfunction from both gend
Each child in the group A will receive the incentive spirometer training , attending three sessions per week for three consecutive months. The duration of the session will be half an hour Set up
- Begin bothering child sit on the mat or chair.
- Hold the incentive spirometer in an upright position.
- The child Breathe out normally.
- Place the spirometer mouthpiece in child's mouth and ask him to close his / her lips tightly around it.
- Ask the child to Breathe in through mouth as slowly and deeply as he can,
- Hold breath for as long as possible, or at least five seconds. Exhale slowly
- Rest for a few seconds, and then repeat the first five steps at least 10 times every hour you're awake.
- After each set of 10 deep breaths, ask child cough deeply to clear lungs
干预措施: Group A (Device)
Group B :Will include 16 spastic diplegic Children suffer from pulmonary dysfunction from both gende
Each child in the group B will receive the oropharyngeal motor training programme , attending three sessions per week for three consecutive months. The duration of the session will be an hour The training programme consists of 10 individual mobilization exercises involving orofacial and pharyngeal area that required 45 minutes Each exercise had to be repeated for 10 times.
The 10 exercises are:
- Exercise 1: Pushing Up The Tongue
- Exercise 2: Touching Nose
- Exercise 3: Touching Chin
- Exercise 4: Pushing Tongue Right and Left
- Exercise 5: Folding Tongue
- Exercise 6: Clicking the Tongue
- Exercise 7: Pushing Tongue Against Spoon
- Exercise 8: Holding A Spoon
- Exercise 9: Holding Button with Lips
- Exercise 10: Gargling
干预措施: Group B (Other)
Group C : Will include 16 spastic diplegic Children suffer from pulmonary dysfunction from both gend
Each child in the group C will receive a combination program of the incentive spirometer training and oropharyngeal motor training programme attending three sessions per week for three consecutive months. The duration of the session will be one hour and half that Will be designed into half an hour for the incentive spirometer training and an hour for the oropharyngeal motor training programme
干预措施: Group C (Combination Product)
结局指标
主要结局
forced vital capacity (FVC)
时间窗: Two months
1) By using digital incentive spirometry which is the amount of air that an individual is able to forcibly exhale from his / her lungs after taking the deepest breath they can.
forced expiratory volume at 1 s (FEV1)
时间窗: Two months
1) By using digital incentive spirometry refers to the air an individual can exhale during a forced breath in 1 second
FVC/FEV1 ratio
时间窗: Two months
1) By using digital incentive spirometry refers to the air an individual can exhale during a forced breath in 1 second
expiratory reserve volume (ERV)
时间窗: Two months
1) By using digital incentive spirometry the amount of extra air above normal that you exhale during a forceful breath out.
Peak expiratory flow (PEF)
时间窗: Two months
the volume of air forcefully expelled from the lungs in one quick exhalation
forced expiratory flow (FEF)
时间窗: Two months
the speed that someone can breathe out air from their lungs, measured in the middle of a hard, fast breath out.
tidal volume (TV)
时间窗: Two months
refers to the air an individual can exhale during a forced breath in 1 second
inspiratory reserve volume (IRV)
时间窗: Two months
the additional volume of air that can be inspired at the end of a normal or tidal inspiration
the orofacial myofunctional clinical evaluation
时间窗: Two months
the OMES protocol is an instrument for the clinical evaluation of orofacial structures and functions of children that will permit the examiner to express numerically his perception of the characteristics and behaviors observed, and that can be administered without special equipment and in a brief manner
次要结局
未报告次要终点
研究者
Alaa Ebrahim Ahmed Mohammed Elshamy
Bachelor's degree
Kafrelsheikh University