Pulmonary DysfunctionEarly Phase 1NCT06806007
Incentive Spirometer Training and Oropharyngeal Motor Training for Pulmonary Dysfunction in Spastic Diplegic Children
A Early Phase 1 study testing Group A, Group B and Group C in people with Pulmonary Dysfunction and Spastic Diaplegia, run by Kafrelsheikh University at 2 sites in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Pulmonary Dysfunction, Spastic Diaplegia
- What is being tested?
- Group A, Group B and Group C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Oct 2024to 1 Oct 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of physical therapy Kafrelsheikh University
Kafrelsheikh, KafrelsheikhU
Faculty of physical therapy Kafrelsheikh University
Kafrelsheikh, Kafrelsheikh
About this study
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
Read the 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
- Being tested
- Group A, Group B, Group C
- Keywords
- Pulmonary dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
- 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 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 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Combination Product: Group C |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced vital capacity (FVC)
- 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.
Measured: Two months
forced expiratory volume at 1 s (FEV1)
- By using digital incentive spirometry refers to the air an individual can exhale during a forced breath in 1 second
Measured: Two months
FVC/FEV1 ratio
- By using digital incentive spirometry refers to the air an individual can exhale during a forced breath in 1 second
Measured: Two months
expiratory reserve volume (ERV)
- By using digital incentive spirometry the amount of extra air above normal that you exhale during a forceful breath out.
Measured: Two months
Peak expiratory flow (PEF)
the volume of air forcefully expelled from the lungs in one quick exhalation
Measured: 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.
Measured: Two months
tidal volume (TV)
refers to the air an individual can exhale during a forced breath in 1 second
Measured: Two months
inspiratory reserve volume (IRV)
the additional volume of air that can be inspired at the end of a normal or tidal inspiration
Measured: 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
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start15 Oct 2024
- Primary completion30 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Ebrahim Ahmed Mohammed Elshamy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806007
- Sponsor's protocol ID
- KFSIRB200-342
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentive Spirometer Training and Oropharyngeal Motor Training for Pulmonary Dysfunction in Spastic Diplegic Children
- ClinicalTrials.gov ID
- NCT06806007
- Acronym / sponsor ID
- KFSIRB200-342
- Conditions
- Pulmonary Dysfunction, Spastic Diaplegia
- Keywords
- Pulmonary dysfunction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A : Will include 16 spastic diplegic Children suffer from pulmonary dysfunction from both gend | Experimental | Device: Group AEach 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 | Experimental | Other: Group BEach 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 C : Will include 16 spastic diplegic Children suffer from pulmonary dysfunction from both gend | Experimental | Combination Product: Group CEach 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 |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group AEach 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 : Will include 16 spastic diplegic Children suffer from pulmonary dysfunction from both gend |
| Group BEach 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 | Other | Group B :Will include 16 spastic diplegic Children suffer from pulmonary dysfunction from both gende |
| Group CEach 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 : Will include 16 spastic diplegic Children suffer from pulmonary dysfunction from both gend |
Primary outcome
forced vital capacity (FVC)
Time frame: 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.
forced expiratory volume at 1 s (FEV1)
Time frame: Two months
1) By using digital incentive spirometry refers to the air an individual can exhale during a forced breath in 1 second
FVC/FEV1 ratio
Time frame: 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)
Time frame: 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)
Time frame: Two months
the volume of air forcefully expelled from the lungs in one quick exhalation
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.
tidal volume (TV)
Time frame: Two months
refers to the air an individual can exhale during a forced breath in 1 second
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Group A, Group B and Group C in people with Pulmonary Dysfunction and Spastic Diaplegia, run by Kafrelsheikh University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
forced vital capacity (FVC) (time frame: Two months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.