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

NCT ID: NCT06806007

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2025-10-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

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 Type: EXPERIMENTAL

Group A

Intervention Type: DEVICE

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 :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

Group Type: EXPERIMENTAL

Group B

Intervention Type: OTHER

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 : 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

Group Type: EXPERIMENTAL

Group C

Intervention Type: COMBINATION_PRODUCT

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

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: OTHER

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Ebrahim Ahmed Mohammed Elshamy

Bachelor's degree

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of physical therapy Kafrelsheikh University

Kafrelsheikh, KafrelsheikhU, Egypt

Faculty of physical therapy Kafrelsheikh University

Kafrelsheikh, Kafrelsheikh, Egypt

Countries

Egypt

Other Identifiers

KFSIRB200-342

Identifier Type: -

Identifier Source: org_study_id