NCT06806007

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Oct 2024

Shorter than P25 for early_phase_1

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

January 28, 2025

Last Update Submit

January 28, 2025

Conditions

Pulmonary DysfunctionSpastic Diaplegia

Keywords

Pulmonary dysfunction

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (3)

Group A : Will include 16 spastic diplegic Children suffer from pulmonary dysfunction from both gend

EXPERIMENTAL

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

Group B :Will include 16 spastic diplegic Children suffer from pulmonary dysfunction from both gende

EXPERIMENTAL

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

Group C : Will include 16 spastic diplegic Children suffer from pulmonary dysfunction from both gend

EXPERIMENTAL

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

Interventions

Group ADEVICE

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 A : Will include 16 spastic diplegic Children suffer from pulmonary dysfunction from both gend
Group BOTHER

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 B :Will include 16 spastic diplegic Children suffer from pulmonary dysfunction from both gende
Group CCOMBINATION_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

Group C : Will include 16 spastic diplegic Children suffer from pulmonary dysfunction from both gend

Eligibility Criteria

Age3 Years - 7 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of physical therapy Kafrelsheikh University

Kafrelsheikh, KafrelsheikhU, Egypt

Location

Faculty of physical therapy Kafrelsheikh University

Kafrelsheikh, Kafrelsheikh, Egypt

Location

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Intervention study model Parallel assignment The study will include 48 spastic diplegic children suffering from pulmonarydysfunction ( age 3-7 years old ) Children meeting the inclusion criteria will be randomly assigned to three experimental groups : First experimental group: children in this group will receive the incentive spirometer training Second experimental group: children in this group will receive oropharyngeal motor training Third experimental group: children in this group will receive a combination program of the incentive spirometer training and oropharyngeal motor training
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bachelor's degree

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 3, 2025

Study Start

October 15, 2024

Primary Completion

August 30, 2025

Study Completion

October 1, 2025

Last Updated

February 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)