NCT06806007

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

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Kafrelsheikh University · Academic / Other
• Sex: All
• Age: 3 Years – 7 Years
• Healthy volunteers: Not accepted

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

Detailed description

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

Conditions

• Pulmonary Dysfunction
• Spastic Diaplegia

Interventions

Type	Name	Description
DEVICE	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
OTHER	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
COMBINATION_PRODUCT	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

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-08-30
• Completion: 2025-10-01
• First posted: 2025-02-03
• Last updated: 2025-02-03

Locations

2 sites across 1 country: Egypt