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Active, not recruiting Early Phase 1

Incentive Spirometer Training and Oropharyngeal Motor Training for Pulmonary Dysfunction in Spastic Diplegic Children

NCT06806007 · tracked via the Priya Life Science Egypt tracker
Phase
Early Phase 1
Started
2024-10-15
Last updated
2025-02-03

Condition(s) studied

Pulmonary DysfunctionSpastic Diaplegia

Investigational drug(s) / intervention(s)

Group AGroup BGroup C

Group A: 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

Group B: 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

Group C: 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

Study summary

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

Eligibility

Sex
ALL
Min age
3 Years
Max age
7 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

  • forced vital capacity (FVC) — 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) — 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 — 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) — 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) — Two months
    the volume of air forcefully expelled from the lungs in one quick exhalation
  • forced expiratory flow (FEF) — 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) — Two months
    refers to the air an individual can exhale during a forced breath in 1 second
  • inspiratory reserve volume (IRV) — 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 — 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

Trial sites (2)

FacilityCityRegionStatus
Faculty of physical therapy Kafrelsheikh University Kafrelsheikh KafrelsheikhU
Faculty of physical therapy Kafrelsheikh University Kafrelsheikh Kafrelsheikh
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06806007 on ClinicalTrials.gov ↗ ← All trials in Egypt