Clinical trial NCT06806007: Incentive Spirometer Training and Oropharyngeal Motor Training for Pulmonary Dysfunction in Spastic Diplegic Children
Official title: Incentive Spirometer Training and Oropharyngeal Motor Training for Pulmonary Dysfunction in Spastic Diplegic Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Pulmonary Dysfunction
Spastic Diaplegia
Keywords: Pulmonary dysfunction
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 48
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: OTHER

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

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

Primary outcomes:
measure: forced vital capacity (FVC)
timeFrame: Two months
measure: forced expiratory volume at 1 s (FEV1)
timeFrame: Two months
measure: FVC/FEV1 ratio
timeFrame: Two months
measure: expiratory reserve volume (ERV)
timeFrame: Two months
measure: Peak expiratory flow (PEF)
timeFrame: Two months
measure: forced expiratory flow (FEF)
timeFrame: Two months
measure: tidal volume (TV)
timeFrame: Two months
measure: inspiratory reserve volume (IRV)
timeFrame: Two months
measure: the orofacial myofunctional clinical evaluation
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: Kafrelsheikh
country: Egypt
facility: Faculty of physical therapy Kafrelsheikh University
state: KafrelsheikhU
city: Kafrelsheikh
country: Egypt
facility: Faculty of physical therapy Kafrelsheikh University
Study officials:
References: