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NCT Number: NCT06806007

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pulmonary Dysfunction Spastic Diaplegia

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of physical therapy Kafrelsheikh University, Kafrelsheikh, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group A

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

  • 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

Group B

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

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

Primary outcomes

  1. forced vital capacity (FVC)

    Time frame: Two months

    • 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.

  2. forced expiratory volume at 1 s (FEV1)

    Time frame: Two months

    • By using digital incentive spirometry refers to the air an individual can exhale during a forced breath in 1 second

  3. FVC/FEV1 ratio

    Time frame: Two months

    • By using digital incentive spirometry refers to the air an individual can exhale during a forced breath in 1 second

  4. expiratory reserve volume (ERV)

    Time frame: Two months

    • By using digital incentive spirometry the amount of extra air above normal that you exhale during a forceful breath out.

  5. Peak expiratory flow (PEF)

    Time frame: Two months

    the volume of air forcefully expelled from the lungs in one quick exhalation

  6. forced expiratory flow (FEF)

    Time frame: Two months

    the speed that someone can breathe out air from their lungs, measured in the middle of a hard, fast breath out.

  7. tidal volume (TV)

    Time frame: Two months

    refers to the air an individual can exhale during a forced breath in 1 second

  8. inspiratory reserve volume (IRV)

    Time frame: Two months

    the additional volume of air that can be inspired at the end of a normal or tidal inspiration

  9. the orofacial myofunctional clinical evaluation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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