An Early Phase 1 interventional study of Group A and Group B in Pulmonary Dysfunction and Spastic Diaplegia, sponsored by Kafrelsheikh University. Active, not recruiting at 2 sites in Egypt. Open to participants aged 3 Years to 7 Years. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Kafrelsheikh University · Early Phase 1, Interventional, and Other
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
This is a prospective randomized controlled clinical trial, conducted at Kafr El sheikh Hospital.
Conditions: Cerebral Palsy
Kafrelsheikh University is the lead sponsor of 291 studies on the registry; 112 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Level I to IV on the gross motor function classification system (GMFCS) , who have the partial ability to maintain antigravity head and trunk postures.
Exclusion Criteria:
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 1. Begin bothering child sit on the mat or chair. 2. Hold the incentive spirometer in an upright position. 3. The child Breathe out normally. 4. Place the spirometer mouthpiece in child's mouth and ask him to close his / her lips tightly around it. 5. Ask the child to Breathe in through mouth as slowly and deeply as he can, 6. Hold breath for as long as possible, or at least five seconds. Exhale slowly 7. Rest for a few seconds, and then repeat the first five steps at least 10 times every hour you're awake. 8. After each set of 10 deep breaths, ask child cough deeply to clear lungs
Device: Group A
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
Other: Group B
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
Combination Product: Group C
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 1. Begin bothering child sit on the mat or chair. 2. Hold the incentive spirometer in an upright position. 3. The child Breathe out normally. 4. Place the spirometer mouthpiece in child's mouth and ask him to close his / her lips tightly around it. 5. Ask the child to Breathe in through mouth as slowly and deeply as he can, 6. Hold breath for as long as possible, or at least five seconds. Exhale slowly 7. Rest for a few seconds, and then repeat the first five steps at least 10 times every hour you're awake. 8. After each set of 10 deep breaths, ask child cough deeply to clear lungs
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 consisted 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
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
forced vital capacity (FVC)
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.
Time frame: Two months
forced expiratory volume at 1 s (FEV1)
1\) By using digital incentive spirometry refers to the air an individual can exhale during a forced breath in 1 second
Time frame: Two months
FVC/FEV1 ratio
1\) By using digital incentive spirometry refers to the air an individual can exhale during a forced breath in 1 second
Time frame: Two months
expiratory reserve volume (ERV)
1\) By using digital incentive spirometry the amount of extra air above normal that you exhale during a forceful breath out.
Time frame: Two months
Peak expiratory flow (PEF)
the volume of air forcefully expelled from the lungs in one quick exhalation
Time frame: Two months
forced expiratory flow (FEF)
the speed that someone can breathe out air from their lungs, measured in the middle of a hard, fast breath out.
Time frame: Two months
tidal volume (TV)
refers to the air an individual can exhale during a forced breath in 1 second
Time frame: Two months
inspiratory reserve volume (IRV)
the additional volume of air that can be inspired at the end of a normal or tidal inspiration
Time frame: Two months
the orofacial myofunctional clinical evaluation
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
Time frame: Two months
Plan to share: No
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