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

Early Phase 1

Active, not recruiting

• Conditions: Pulmonary Dysfunction; Spastic Diaplegia

• Registration Number: NCT06806007
• Lead Sponsor: Kafrelsheikh University

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

Study Timeline

• Study Start: 2024-10-15
• Status Verified: 2025-01
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-02-03
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-08-30
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
forced expiratory volume at 1 s (FEV1)	Two months	1) By using digital incentive spirometry refers to the air an individual can exhale during a forced breath in 1 second
forced vital capacity (FVC)	Two months	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.
FVC/FEV1 ratio	Two months	1) By using digital incentive spirometry refers to the air an individual can exhale during a forced breath in 1 second
expiratory reserve volume (ERV)	Two months	1) By using digital incentive spirometry the amount of extra air above normal that you exhale during a forceful breath out.
Peak expiratory flow (PEF)	Two months	the volume of air forcefully expelled from the lungs in one quick exhalation
forced expiratory flow (FEF)	Two months	the speed that someone can breathe out air from their lungs, measured in the middle of a hard, fast breath out.
tidal volume (TV)	Two months	refers to the air an individual can exhale during a forced breath in 1 second
inspiratory reserve volume (IRV)	Two months	the additional volume of air that can be inspired at the end of a normal or tidal inspiration
the orofacial myofunctional clinical evaluation	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

Trial Locations

Locations (1)

Faculty of physical therapy Kafrelsheikh University; 🇪🇬 Kafrelsheikh, Egypt