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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Dysfunction; Spastic Diaplegia
• Intervention / Treatment: Device: Group A; Other: Group B; Combination product: Group C

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

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Kafrelsheikh, Egypt
    • Faculty of physical therapy Kafrelsheikh university
  • KafrelsheikhU
    • Kafrelsheikh, KafrelsheikhU, Egypt
      • Faculty of physical therapy Kafrelsheikh university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; 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
Experimental: 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	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
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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.	Two months
Peak expiratory flow (PEF)	the volume of air forcefully expelled from the lungs in one quick exhalation	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.	Two months
tidal volume (TV)	refers to the air an individual can exhale during a forced breath in 1 second	Two months
inspiratory reserve volume (IRV)	the additional volume of air that can be inspired at the end of a normal or tidal inspiration	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	Two months

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Pulmonary dysfunction
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Muscle Spasticity
• Other Study ID Numbers: KFSIRB200-342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes