Pneumonia ChildhoodNCT06573047
Thoracic KT on Pulmonary Function Ichildren with Pneumonia
A study testing kinesotape and Chest physiotherapy exercises in people with Pneumonia Childhood, run by Cairo University.
Trial summary
This study aimed to investigate the effect of thoracic kinesio-tape on Pulmonary Functions, time to clinical resolution and respiratory rate and arterial oxygen saturation in children with pneumonia. Thirty children with pneumonia from both sexes with age ranged from 4 to 7 years participated in this study. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Pneumonia Childhood
- What is being tested?
- kinesotape and Chest physiotherapy exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with age between aged 4 years to 7 years hospitalized with pneumonia and they assemble all the clinical and radiological criteria for pneumonia
- Children with normal thoracic spine
- Children with stable hemodynamic status
- Children with no previous history of thoracic surgery, thoracic deformities rib fracture or any condition that make it difficult to apply the KT.
Who cannot join
- Children with chest drain
- Children with vision or auditory problems
- Bone fragility or rib fractures
- Children with reports of allergic skin reactions to the use of adhesive bandages, plasters, or other adhesive materials
- Children on ventilator
- cp children
Trial locations and contacts
No sites are listed yet.
Mohamed Elshafeay contact
About this study
Official title: Effect of Thoracic Kineso Tape on Pulmonary Function in Children with Pneumonia
This study aimed to investigate the effect of thoracic kinesio-tape on Pulmonary Functions, time to clinical resolution and respiratory rate and arterial oxygen saturation in children with pneumonia.
Thirty children with pneumonia from both sexes with age ranged from 4 to 7 years participated in this study. The patients were divided into two equal groups (study and control groups), control group received selected chest physiotherapy exercise. Study group received the same selected physical therapy program given to control group in addition to thoracic kinesio-tape three days per week for two weeks.
Read the detailed description
The study targeted the children with pneumonia (4-7) from both sexes will be selected from tala general hospital in menofia Study design: Randomized controlled trial.
Inclusion Criteria:
1- Children with age between aged 4years to 7 years hospitalized with pneumonia and they assemble all the clinical and radiological criteria for pneumonia 2- Children with stable hemodynamic status 3- Children with no previous history of thoracic surgery, thoracic deformities rib fracture or any condition that make it difficult to apply the KT.
Exclusion criteria:
- Children with chest drain
- Children with vision or auditory problems
- Bone fragility or rib fractures
- Children with reports of allergic skin reactions to the use of adhesive bandages, plasters, or other adhesive materials
- Children on ventilator
- cp children
- For Children Selection
- X-ray to detect the presence of lung infiltrates indicated II. For Children Evulation a- Digital spirometer: used to measure pulmonary function include (vital capcity -forced vital capcity -forced expiratory volume1-forced expiratory volume1/forced vital capcity ratio-peak expiratory flow) at the start and at the end of the study. B- A pulse oximeter : used to measure oxygen saturation. It is a non-invasive device placed over a person's finger. C - The Clinical Respiratory Score (CRS) : The Clinical Respiratory Score appears to have potential as a screening tool for respiratory distress presentations (of several etiologies) in the paediatric emergency department setting of a Low and Middle -Income Countries .Respiratory Score assessed respiratory status in children hospital. For treatment a- Kinesio-tape made from 100% gentle cotton fibre and 100% medical grade acrylic adhesive. its Hypoallergenic, water-resistant and does not limit range of motion (ROM). Kinesio Tape is safe enough for a baby's sensitive skin, and gentle enough for aging individuals, flexible enough for rehabilitation, durable enough to support working muscle, joint or ligament and strong enough for athletes at any level. c- Procedures I. For Children Selection
- All chest radiographs will be interpreted in the department of radiology (A/P view) and reviewed by pediatric chest physician
- Children will be clinically evaluated at enrolment of the study and at discharge. A standardized protocol will be taken to record respiratory rate, arterial oxygen saturation. II. For Children Evaluation: all children will be evaluated before and after intervention and after 2 weeks from intervention by
1- Pulmonary functions testing: To perform the measurement, subjects will be instructed to sit on an armless chair with back support while their knees flexed to 90° and nostrils will be occluded by a nose clip. Then they will perform a maximal inspiration followed by a forced expiration, exhaling as much air as possible 3 seconds. This maneuver will be repeated 3 times, and the highest scores will be recorded for analyses.
2- Time to clinical resolution which will be defined as the number of days needed for a patient to achieve the following clinical parameters: afebrile (daily maximum body temperature:37.5°C, oxygen saturation :95% and absence of severe signs 3- Respiratory rate and arterial oxygen saturation. A standardized protocol will be taken to record respiratory rate, arterial oxygen saturation. The standard technique for measurement of respiratory rate and arterial oxygen saturation will be the same as previously reported. The daily maximum body temperature was noted by the pediatrician based on the patient's nursing record. The patient's axillary temperature was measured by the attending nurses every 3 hours throughout the hospital stay. All physicians and nurses will be blinded to group assignment and study protocol.
4-The Clinical Respiratory Score (CRS) : The four clinical parameters were : respiratory rate , retractions ,dyspnea and auscultation (table 1) . the score ranged from 1-12 with a higher score indicating more respiratory distress .The score was designed for use while child was awake. the total score obtained there can be 3 categories of respiratory distress: Mild (1- 3), Moderate (4-7), Severe (8-12)
III. Procedures for treatment The control group : the children in the control group will receive the selected chest physiotherapy exercise three times per week for two weeks, each session will be about 20 minutes which included the following exercise;
- Postural drainage : which involves positioning of the child with the assistance of gravity to mobilize secretions towards the main bronchus .
- Vibration: In this technique, a rapid vibratory impulse is transmitted through the chest wall from the flattened hands of the therapist by isometric alternate contraction of forearm flexor and extensor muscles, to loosen and dislodge the airway secretions .
- Percussion: The therapist uses a single hand or both cupped hands or three fingers with the middle finger tented, or a facemask with the port either covered or occluded by a finger, and strikes repeatedly at a rate of three per second over the part of the bronchopulmonary segment that needs to be drained.
- Huffing: Fast expiration at high volume by the patient .
- Coughing: Child is requested to cough. In uncooperative or small children, tracheal stimulation or tickling can be performed by placing index finger or thumb on the anterior side of the neck against trachea just above sternal notch with gentle but firm inward pressure in a circular pattern as the child begins to exhale • Thoracic squeezing. This method stimulates the normal cough mechanism through elevation of intrathoracic pressure. This technique, which does not require any special equipment, is used exclusively for the thorax. The hands are placed on the lower third of the thorax. The therapist then applies pressure to increase the forced expiratory volume (FEV) by 30%. It is not necessary to disconnect the patient from the ventilation machine during treatment, which decreases episodes of hypoxemia and the use of high fraction of inspired oxygen (FiO2)
The control Group (B): will receive selected chest physical therapy exercise three times per week for two weeks, each session will be about 20 minutes plus thoracic kinesio-tape every three days (5 times per two weeks). Children will be seated on a chair. When the children will be at the end of the expiration, it will be applied bilaterally on the fifth to sixth and ninth to tenth intercostal muscles transversally and on the anterior and posterior axillary line longitudinally with 50% tension. To stimulate the muscle and support the function, the stimulation technique is usually applied from the origin to the insertion of the muscle with the recommended stretching of 25 to 50%. KT is changed on every third day (for a total of 5 times per two weeks). The children or the care giver will be instructed not to take the tapes off at any time but they will be allowed to take showers. The researcher will complete post treatment evaluations after two weeks for each patient and recorded the data.
- Conditions
- Pneumonia Childhood
- Being tested
- kinesotape, Chest physiotherapy exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesotapeOther
a- Kinesio-tape: cure tape (made in Korea) made from 100% gentle cotton fibre and 100% medical grade acrylic adhesive. its Hypoallergenic, water-resistant and does not limit range of motion (ROM), it is come with different colours and sizes. Kinesio Tape is safe enough for a baby's sensitive skin, and gentle enough for aging individuals, flexible enough for rehabilitation, durable enough to support working muscle, joint or ligament and strong enough for athletes at any level.
Chest physiotherapy exercisesBehavioural
selected chest physiotherapy exercise three times per week for two weeks, each session will be about 20 minute which will include the following exercise ( huffing , coughing , percussion,and postural drainage)
| Study group | Role | What they receive |
|---|---|---|
| Kinesotape | Other | Children in group (b)will receive selected chest physical therapy exercise which including (percussion, huffing, coughing and postural drainage)three times per week for two weeks, each session will be about 20 minutesplus thoracic kinesio-tape every three days (5 times per two weeks). Children will be seated on a chair. When the children will be at the end of the expiration, it will be applied bilaterally on the fifth to sixth and ninth to tenth intercostal muscles transversally and on the anterior and posterior axillary line longitudinally with 50% tension Receives: Other: kinesotape |
| chest physiotherapy exercises | Other | the children in the group(a) will receive the selected chest physiotherapy exercise three times per week for two weeks, each session will be about 20 minute which will include the following exercise ( huffing , coughing , percussion,and postural drainage) Receives: Behavioral: Chest physiotherapy exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary function
Vital capacity will carried out by using digital spirometer
Measured: baseline- 5min for each participant
Forced vital capacity
By using digital spirometer
Measured: baseline- 5min for each participant
Forced expiratory volume in one second
By using digital spirometer
Measured: baseline- 5min for each participant
Forced vital capacity/forced expiratory volume in one second ratio
By using digital spirometer
Measured: baseline- 5min for each participant
Peak expiratory flow
By using digital spirometer
Measured: baseline- 5min for each participant
Oxygen saturation
By using oximeter
Measured: baseline- 5min for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study startMay 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia ChildhoodStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ali taher elhanfi, Cairo University
- Investigators
- Sara Elhanfi, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573047
- Sponsor's protocol ID
- p.t.rec/012/004544
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracic Kineso Tape on Pulmonary Function in Children with Pneumonia
- ClinicalTrials.gov ID
- NCT06573047
- Acronym / sponsor ID
- p.t.rec/012/004544
- Conditions
- Pneumonia Childhood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 27 Aug 2024 (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.
This study aimed to investigate the effect of thoracic kinesio-tape on Pulmonary Functions, time to clinical resolution and respiratory rate and arterial oxygen saturation in children with pneumonia.
Thirty children with pneumonia from both sexes with age ranged from 4 to 7 years participated in this study. The patients were divided into two equal groups (study and control groups), control group received selected chest physiotherapy exercise. Study group received the same selected physical therapy program given to control group in addition to thoracic kinesio-tape three days per week for two weeks.
Detailed description
The study targeted the children with pneumonia (4-7) from both sexes will be selected from tala general hospital in menofia Study design: Randomized controlled trial.
Inclusion Criteria:
1- Children with age between aged 4years to 7 years hospitalized with pneumonia and they assemble all the clinical and radiological criteria for pneumonia 2- Children with stable hemodynamic status 3- Children with no previous history of thoracic surgery, thoracic deformities rib fracture or any condition that make it difficult to apply the KT.
Exclusion criteria:
- Children with chest drain
- Children with vision or auditory problems
- Bone fragility or rib fractures
- Children with reports of allergic skin reactions to the use of adhesive bandages, plasters, or other adhesive materials
- Children on ventilator
- cp children
- For Children Selection
- X-ray to detect the presence of lung infiltrates indicated II. For Children Evulation a- Digital spirometer: used to measure pulmonary function include (vital capcity -forced vital capcity -forced expiratory volume1-forced expiratory volume1/forced vital capcity ratio-peak expiratory flow) at the start and at the end of the study. B- A pulse oximeter : used to measure oxygen saturation. It is a non-invasive device placed over a person's finger. C - The Clinical Respiratory Score (CRS) : The Clinical Respiratory Score appears to have potential as a screening tool for respiratory distress presentations (of several etiologies) in the paediatric emergency department setting of a Low and Middle -Income Countries .Respiratory Score assessed respiratory status in children hospital. For treatment a- Kinesio-tape made from 100% gentle cotton fibre and 100% medical grade acrylic adhesive. its Hypoallergenic, water-resistant and does not limit range of motion (ROM). Kinesio Tape is safe enough for a baby's sensitive skin, and gentle enough for aging individuals, flexible enough for rehabilitation, durable enough to support working muscle, joint or ligament and strong enough for athletes at any level. c- Procedures I. For Children Selection
- All chest radiographs will be interpreted in the department of radiology (A/P view) and reviewed by pediatric chest physician
- Children will be clinically evaluated at enrolment of the study and at discharge. A standardized protocol will be taken to record respiratory rate, arterial oxygen saturation. II. For Children Evaluation: all children will be evaluated before and after intervention and after 2 weeks from intervention by
1- Pulmonary functions testing: To perform the measurement, subjects will be instructed to sit on an armless chair with back support while their knees flexed to 90° and nostrils will be occluded by a nose clip. Then they will perform a maximal inspiration followed by a forced expiration, exhaling as much air as possible 3 seconds. This maneuver will be repeated 3 times, and the highest scores will be recorded for analyses.
2- Time to clinical resolution which will be defined as the number of days needed for a patient to achieve the following clinical parameters: afebrile (daily maximum body temperature:37.5°C, oxygen saturation :95% and absence of severe signs 3- Respiratory rate and arterial oxygen saturation. A standardized protocol will be taken to record respiratory rate, arterial oxygen saturation. The standard technique for measurement of respiratory rate and arterial oxygen saturation will be the same as previously reported. The daily maximum body temperature was noted by the pediatrician based on the patient's nursing record. The patient's axillary temperature was measured by the attending nurses every 3 hours throughout the hospital stay. All physicians and nurses will be blinded to group assignment and study protocol.
4-The Clinical Respiratory Score (CRS) : The four clinical parameters were : respiratory rate , retractions ,dyspnea and auscultation (table 1) . the score ranged from 1-12 with a higher score indicating more respiratory distress .The score was designed for use while child was awake. the total score obtained there can be 3 categories of respiratory distress: Mild (1- 3), Moderate (4-7), Severe (8-12)
III. Procedures for treatment The control group : the children in the control group will receive the selected chest physiotherapy exercise three times per week for two weeks, each session will be about 20 minutes which included the following exercise;
- Postural drainage : which involves positioning of the child with the assistance of gravity to mobilize secretions towards the main bronchus .
- Vibration: In this technique, a rapid vibratory impulse is transmitted through the chest wall from the flattened hands of the therapist by isometric alternate contraction of forearm flexor and extensor muscles, to loosen and dislodge the airway secretions .
- Percussion: The therapist uses a single hand or both cupped hands or three fingers with the middle finger tented, or a facemask with the port either covered or occluded by a finger, and strikes repeatedly at a rate of three per second over the part of the bronchopulmonary segment that needs to be drained.
- Huffing: Fast expiration at high volume by the patient .
- Coughing: Child is requested to cough. In uncooperative or small children, tracheal stimulation or tickling can be performed by placing index finger or thumb on the anterior side of the neck against trachea just above sternal notch with gentle but firm inward pressure in a circular pattern as the child begins to exhale • Thoracic squeezing. This method stimulates the normal cough mechanism through elevation of intrathoracic pressure. This technique, which does not require any special equipment, is used exclusively for the thorax. The hands are placed on the lower third of the thorax. The therapist then applies pressure to increase the forced expiratory volume (FEV) by 30%. It is not necessary to disconnect the patient from the ventilation machine during treatment, which decreases episodes of hypoxemia and the use of high fraction of inspired oxygen (FiO2)
The control Group (B): will receive selected chest physical therapy exercise three times per week for two weeks, each session will be about 20 minutes plus thoracic kinesio-tape every three days (5 times per two weeks). Children will be seated on a chair. When the children will be at the end of the expiration, it will be applied bilaterally on the fifth to sixth and ninth to tenth intercostal muscles transversally and on the anterior and posterior axillary line longitudinally with 50% tension. To stimulate the muscle and support the function, the stimulation technique is usually applied from the origin to the insertion of the muscle with the recommended stretching of 25 to 50%. KT is changed on every third day (for a total of 5 times per two weeks). The children or the care giver will be instructed not to take the tapes off at any time but they will be allowed to take showers. The researcher will complete post treatment evaluations after two weeks for each patient and recorded the data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesotape | Other | Other: kinesotapeChildren in group (b)will receive selected chest physical therapy exercise which including (percussion, huffing, coughing and postural drainage)three times per week for two weeks, each session will be about 20 minutesplus thoracic kinesio-tape every three days (5 times per two weeks). Children will be seated on a chair. When the children will be at the end of the expiration, it will be applied bilaterally on the fifth to sixth and ninth to tenth intercostal muscles transversally and on the anterior and posterior axillary line longitudinally with 50% tension |
| chest physiotherapy exercises | Other | Behavioral: Chest physiotherapy exercisesthe children in the group(a) will receive the selected chest physiotherapy exercise three times per week for two weeks, each session will be about 20 minute which will include the following exercise ( huffing , coughing , percussion,and postural drainage) |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with age between aged 4 years to 7 years hospitalized with pneumonia and they assemble all the clinical and radiological criteria for pneumonia
- Children with normal thoracic spine
- Children with stable hemodynamic status
- Children with no previous history of thoracic surgery, thoracic deformities rib fracture or any condition that make it difficult to apply the KT.
Key exclusion criteria (6 listed)
- Children with chest drain
- Children with vision or auditory problems
- Bone fragility or rib fractures
- Children with reports of allergic skin reactions to the use of adhesive bandages, plasters, or other adhesive materials
- Children on ventilator
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 |
|---|---|---|
| kinesotapea- Kinesio-tape: cure tape (made in Korea) made from 100% gentle cotton fibre and 100% medical grade acrylic adhesive. its Hypoallergenic, water-resistant and does not limit range of motion (ROM), it is come with different colours and sizes. Kinesio Tape is safe enough for a baby's sensitive skin, and gentle enough for aging individuals, flexible enough for rehabilitation, durable enough to support working muscle, joint or ligament and strong enough for athletes at any level. | Other | Kinesotape |
| Chest physiotherapy exercisesselected chest physiotherapy exercise three times per week for two weeks, each session will be about 20 minute which will include the following exercise ( huffing , coughing , percussion,and postural drainage) | Behavioural | chest physiotherapy exercises |
Primary outcome
pulmonary function
Time frame: baseline- 5min for each participant
Vital capacity will carried out by using digital spirometer
Forced vital capacity
Time frame: baseline- 5min for each participant
By using digital spirometer
Forced expiratory volume in one second
Time frame: baseline- 5min for each participant
By using digital spirometer
Forced vital capacity/forced expiratory volume in one second ratio
Time frame: baseline- 5min for each participant
By using digital spirometer
Peak expiratory flow
Time frame: baseline- 5min for each participant
By using digital spirometer
Oxygen saturation
Time frame: baseline- 5min for each participant
By using oximeter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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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.
Mohamed Elshafeay contact
Sara Elhanfi principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing kinesotape and Chest physiotherapy exercises in people with Pneumonia Childhood, run by Cairo University.
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 6 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: status not confirmed, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara elhanfi (+2001221625794, selhanfi54@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary function (time frame: baseline- 5min for each participant). The study lists 6 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 13 Feb 2025.