Lung Boost Trainer Versus Incentive Spirometer in Post COVID-19 Hemiplegic CP Children (COVID-19 CP)

Lung Boost Trainer Versus Incentive Spirometer on Spiro-metric Indices in Post COVID-19 Hemiplegic Cerebral Palsy Children; Randomized Controlled Trial

Cerebral palsy (CP) is the most common physical disability in children. Children with CP have a higher incidence of respiratory dysfunction than healthy children. They usually have recurrent chest infections, bronchiectasis, atelectasis, sleep apnea, and chronic obstructive lung disease. They have high risk of morbidity and mortality due to excessive drooling and frequent aspiration that result in chest infections. Children with spastic CP have decreased chest wall mobility, weak respiratory muscles, and deviation of optimal chest wall structure, resulting in lower pulmonary function than healthy children.

A new coronavirus (SARS-CoV-2) outbreak occurred in December 2019, which caused various clinical symptoms leading to a syndrome called "Corona virus disease of 2019 " ("COVID-19"). COVID-19 can lead to the occurrence of symptoms such as fever, cough, increased airway secretions, dyspnea, weakness and decreased exercise tolerance due to long-term bed rest in isolation. The method to safely rehabilitate COVID-19 patients is an issue that has led to concerns among physiotherapists at present.

Inspiratory Muscle Training (IMT) helps to reduce the level of dyspnea and improves the pulmonary function, respiratory muscle strength and functional capacity. Lung Boost is a device used for respiratory muscles training. Lung Boost is planned for anyone who wishes to improve the strength and endurance of respiratory muscles in an individual, including professional athletes, recreational athletes and healthy individuals. However, this device is not indicated for the people who are too weak or ill to use the device. Furthermore, the device includes screen which play an important role to motivate the child with C.P. and achieve cooperation during program to get best results.

Incentive spirometer exercises are commonly used in combination with chest physiotherapy, which allows the patient to perform gradual deep breaths, allowing for the relaxation and opening of collapsed airways, with motivation through visual input. It is an inexpensive and easy tool used with no reported side effects; meeting the visual goal helps the children to do their best and thus fosters patient compliance.

Treatment procedure:

LBT Group : received lung boost trainer in addition to traditional respiratory muscle training IST Group: received incentive exercises in addition to traditional respiratory muscle training.

TRPT Group: received traditional respiratory physical therapy protocol only. (control group)

HYPOTHESES:

1- There is no Significant difference between Lung boost trainer and incentive spirometer on lung compliance on post-COVID hemiplegic cerebral palsy patients. as regards to:

1. forced expiratory volume at first second (FEV1%),
2. the forced vital capacity (FVC %),
3. FEV1/ FVC ratio
4. 6minute walk test (6MWT)
5. Quality of life questionnaire (SF 36) Study duration has taken 6 months to be completed for all groups. Intervention duration for each child lasts for four weeks with five sessions a week.

RESEARCH QUESTION:

Is there difference between Lung boost trainer and incentive spirometer on lung compliance in post COVID hemiplegic cerebral palsy patients?

Patients will be included:

1. 60 patients from both genders.
2. spastic CP patients between the ages 4 and 9 years.
3. Reasonable cognitive functions and a reasonable IQ so as to be able to follow instructions.
4. after two weeks of COVID19 recovery

Participants excluded if :

1. Had other psychiatric and/or neurological disorders than cerebral palsy as Seizures.
2. Had any spinal deformities that affect chest mobility or pulmonary functions
3. Had medical conditions that could affect respiratory function such as cardiac disease or Chronic respiratory disease or on medications that affect respiratory function

Study Overview

• Status: Completed
• Conditions: CP (Cerebral Palsy); Post Covid-19; Hemiplegic
• Intervention / Treatment: Device: Lung boost trainer (LBT); Device: Incentive Spirometer Training ( IST); Other: Traditional Respiratory Physical Therapy Protocol (TRPT)

Detailed Description

• 60 cerebral palsy children were randomly allocated by sealed opaque envelope in to three groups , lung boost trainer group (LBT) , Incentive spirometer group (IST), and Traditional respiratory physical therapy training group in equal numbers .
• Inspiratory Muscle Training (IMT) helps to reduce the level of dyspnea and improves the pulmonary function, respiratory muscle strength and functional capacity.
• Lung Boost(LBT) is a device used for respiratory muscles training. It is planned for anyone who wishes to improve the strength and endurance of respiratory muscles in an individual, including professional athletes, recreational athletes and healthy individuals. However, this device is not indicated for the people who are too weak or ill to use the device. Furthermore, the device includes screen which play an important role to motivate the child with C.P. and achieve cooperation during program to get best results. it's frequency is 5 sessions per week successive days for 4 weeks , once daily, duration for 15 to 20 minutes. Children were instructed to sit straight, holding the device at mouth level. They placed the mouthpiece deep in their mouths, closed their lips, and inhaled slowly and deeply via the mouthpiece. Therapists adjusted the resistance dial to a level that was demanding but not uncomfortable. Children were encouraged to breathe deeply and slowly, then inhale strongly via the mouthpiece. Inhale for 2-3 seconds, hold briefly, and then exhale for 2-3 seconds for 15 repetitions, followed by 15 seconds. Rest between two sets of exercises.

• Incentive spirometer exercises (IST) are commonly used in combination with chest physiotherapy, which allows the patient to perform gradual deep breaths, allowing for the relaxation and opening of collapsed airways, with motivation through visual input. It is an inexpensive and easy tool used with no reported side effects; meeting the visual goal helps the children to do their best and thus fosters patient compliance. Children were taught to sit calmly for a few minutes and focus on their natural breathing. If possible, patients held the flow-type inhaler in one hand and the mouthpiece and tubing in the other; otherwise, the therapist helped with positioning.

  • The youngster took three to four slow, focused breaths before inserting the incentive spirometer into their mouth. They then inhaled deeply and steadily to lift the ball within the device's chamber, holding the inhalation for at least 2-3 seconds, before exhaling normally away from the mouthpiece.

While TRPT, included diaphragmatic breathing, thoracic expansion, segmental breathing, and light chest mobility exercises based on the functional level of the child. Each session took about 20 minutes and was done five times a week over four weeks with supervision of the therapist.

All outcomes were measured at the start and end of the therapy. Every kid whose outcome measures were recorded received the intervention based on their original allocation. Our study's findings were divided into two categories: primary outcomes (PFT), including several important variables as: forced vital capacity (FVC%), forced expiratory volume in one second (FEV1%), FEV1/FVC ratio, and secondary outcomes, which included a , the Six-Minute Walk Test Distance (6MWT), and the Short Form-36 to measure quality of life.

Pulmonary function tests (PFTs) are tests that show how well your lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. This information can help your healthcare provider diagnose and decide the treatment of certain lung disorders. It includes several important variables such as:

1. Forced vital capacity (FVC%) is the amount of air breathed out forcefully and quickly after breathing in as much as you can.
2. Forced expiratory volume (FEV1%) is the amount of air breathed out during the first, second, and third seconds of the FVC test. All patients were instructed to inhale and exhale deeply their full capacity of lung while repeating at minimum 3 times with rest between trials.

3. FEV1/ FVC ratio: Then the highest value was taken, and after the PFT data had been normalized for age, gender, and height (percent), the estimated FEV1 and FVC values were computed.

   • Six-minute walk test (6MWT) is a standard test to assess exercise capacity objectively and determine prognosis in many respiratory (such as COPD, idiopathic pulmonary fibrosis, and pulmonary hypertension) and non-respiratory conditions (such as heart failure) . The minimal clinically important difference for change in the 6MWT distance of adults is approximately 30 meters. The 6MWT is not designed to be used for home oxygen titration and assessment, and a separate study is recommended to assess the need and dose of supplemental oxygen. Performance of the test requires the presence of a flat, straight corridor 30 m (100 feet) in length, the ability to monitor heart rate and pulse oximetry throughout the test, and if the patient uses supplemental oxygen, to record the flow rate and type of Oxygen device.

Short form 36 (SF-36) is a valid and frequently used scale to evaluate HRQoL, specific for no groups of age, disorder, and treatment, includes general health concepts, and composed of 36 questions with 8 subscales as physical function, role limitation physical, role limitation emotional, bodily pain, social function, mental health, vitality, and general health. Scores of items are encoded for each subscale and formed as a scale ranging from 0 (poorest health status) to 100 (best health status). SF-36 has two summary measures as physical component scale (PCS) and mental component scale (MCS). PCS is comprised of subscales of physical function, role physical, bodily pain, and general health, and MCS is comprised of subscales of vitality, social function, role emotional, and mental health.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Heliopolis
    • Cairo, Heliopolis, Egypt, 11757
      • Amira Galal Mahmoud
    • Cairo, Heliopolis, Egypt, 11757
      • Doaa Adel Abdel Aziz
    • Cairo, Heliopolis, Egypt, 11757
      • Faten Mohamed Hassan
    • Cairo, Heliopolis, Egypt, 11757
      • Mai Abdelghani Eid
    • Cairo, Heliopolis, Egypt, 11757
      • Mai Magdy Ahmed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 60 patients from both genders.
2. spastic CP patients between the ages 4 and 9 years.
3. Reasonable cognitive functions and a reasonable IQ so as to be able to follow instructions.
4. after two weeks of COVID19 recovery

Exclusion Criteria:

1. Had other psychiatric and/or neurological disorders than cerebral palsy as Seizures.
2. Had any spinal deformities that affect chest mobility or pulmonary functions
3. Had medical conditions that could affect respiratory function such as cardiac disease or Chronic respiratory disease or on medications that affect respiratory function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: received lung boost trainer (LBT) in addition to traditional respiratory muscle training; (LBT) is a device used for respiratory muscles training. It is planned for anyone who wishes to improve the strength and endurance of respiratory muscles in an individual, including professional athletes, recreational athletes and healthy individuals. It includes screen which play an important role to motivate the child with C.P. and achieve cooperation during program to get best results. it's frequency is 5 sessions per week successive days for 4 weeks , once daily , duration for 15 to 20 minutes. Children were instructed to sit straight, holding the device at mouth level. They placed the mouthpiece deep in their mouths, closed their lips, and inhaled slowly and deeply via the mouthpiece. Therapists adjusted the resistance dial to a level that was demanding but not uncomfortable. Children were encouraged to breathe deeply and slowly, then inhale strongly via the mouthpiece. They Inhaled for 2-3 seconds, hold briefly, and then exhaled for 2-3seconds	Device: Lung boost trainer (LBT); (LBT) is a device used for respiratory muscles training. It is planned for anyone who wishes to improve the strength and endurance of respiratory muscles in an individual, including professional athletes, recreational athletes and healthy individuals. However, this device is not indicated for the people who are too weak or ill to use the device. Furthermore, the device includes screen which play an important role to motivate the child with C.P. and achieve cooperation during program to get best results. it's frequency is 5 sessions per week successive days for 4 weeks , once daily, duration for 15 to 20 minutes. Children were encouraged to breathe deeply and slowly, then inhale strongly via the mouthpiece. Inhale for 2-3 seconds, hold briefly, and then exhale for 2-3 seconds for 15 repetitions, followed by 15 seconds. Rest between two sets of exercises. The children were instructed to breathe deeply and slowly followed by a strong inhalation with the help of the mouthpiece.
Experimental: received incentive spirometry training (IST) in addition to traditional respiratory muscle training.; Incentive spirometer exercises (IST) are commonly used in combination with chest physiotherapy, which allows the patient to perform gradual deep breaths, allowing for the relaxation and opening of collapsed airways, with motivation through visual input. It is an inexpensive and easy tool used with no reported side effects; meeting the visual goal helps the children to do their best and thus fosters patient compliance. Children were taught to sit calmly for a few minutes and focus on their natural breathing. If possible, patients held the flow-type inhaler in one hand and the mouthpiece and tubing in the other; otherwise, the therapist helped with positioning. • The youngster took three to four slow, focused breaths before inserting the incentive spirometer into their mouth. They then inhaled deeply and steadily to lift the ball within the device's chamber, holding the inhalation for at least 2-3 seconds, before exhaling normally away from the mouthpiece.	Device: Incentive Spirometer Training ( IST); Incentive spirometer exercises (IST) are commonly used in combination with chest physiotherapy, which allows the patient to perform gradual deep breaths, allowing for the relaxation and opening of collapsed airways, with motivation through visual input. It is an inexpensive and easy tool used with no reported side effects; meeting the visual goal helps the children to do their best and thus fosters patient compliance. Children were taught to sit calmly for a few minutes and focus on their natural breathing. If possible, patients held the flow-type inhaler in one hand and the mouthpiece and tubing in the other; otherwise, the therapist helped with positioning. • The youngster took three to four slow, focused breaths before inserting the incentive spirometer into their mouth. They then inhaled deeply and steadily to lift the ball within the device's chamber, holding the inhalation for at least 2-3 seconds, before exhaling normally away from the mouthpiece.
Active Comparator: Traditional Respiratory Physical Therapy Protocol (TRPT); The program included diaphragmatic breathing, thoracic expansion, segmental breathing, and light chest mobility exercises based on the functional level of the child. Each session took about 20 minutes and was done five times a week over four weeks with supervision of the therapist.	Other: Traditional Respiratory Physical Therapy Protocol (TRPT); included diaphragmatic breathing, thoracic expansion, segmental breathing, and light chest mobility exercises based on the functional level of the child. Each session took about 20 minutes and was done five times a week over four weeks with supervision of the therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary function test (PFT) :	Pulmonary function tests (PFTs) are tests that show how well your lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange using spirometer. This information can help your healthcare provider diagnose and decide the treatment of certain lung disorders. It includes several important variables such as: Forced vital capacity (FVC%): is the amount of air breathed out forcefully and quickly after breathing in as much as you can.; Forced expiratory volume (FEV1%): is the amount of air breathed out during the first, second, and third seconds of the FVC test. All patients were instructed to inhale and exhale deeply their full capacity of lung while repeating at minimum 3 times with rest between trials. C) FEV1/FVC ratio : Then the highest value was taken, and after the PFT data had been normalized for age, gender, and height (percent), the estimated FEV1 and FVC values were computed.	At baseline and after 4 weeks
forced vital capacity (FVC%)	Before the assessment, the participants were comfortably seated and had an adequate education. All participants were instructed to deeply inhale and exhale their full lung capacity into the spirometer while repeating at minimum 3 times with enough rest between attempts, to prevent hyperventilation.	at baseline and after 4 weeks
Forced expiratory volume (FEV1%):	is the amount of air breathed out during the first, second, and third seconds of the FVC test. All patients were instructed to inhale and exhale deeply their full capacity of lung while repeating at minimum 3 times with rest between trials.	at baseline and after 4 weeks
FEV1/FVC ratio :	After the PFT data had been normalized for age, gender, and height (percent),the highest value was taken, the estimated FEV1 and FVC values were computed.	at baseline and after 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute walk test (6MWT)	Six-minute walk test (6MWT) is a standard test to assess exercise capacity objectively and determine prognosis in many respiratory (such as COPD, idiopathic pulmonary fibrosis, and pulmonary hypertension) and non-respiratory conditions (such as heart failure) . The minimal clinically important difference for change in the 6MWT distance of adults is approximately 30 meters. The 6MWT is not designed to be used for home oxygen titration and assessment, and a separate study is recommended to assess the need and dose of supplemental oxygen. Performance of the test requires the presence of a flat, straight corridor 30 m (100 feet) in length, the ability to monitor heart rate and pulse oximetry throughout the test, and if the patient uses supplemental oxygen, to record the flow rate and type of Oxygen device. Ahead of this, the children were requested to walk around as many times as possible in 6 minutes and not to run, so the distance was measured in meters after 6 minutes.	At baseline and after 4 weeks
Short form 36 (SF-36)	Short form 36 (SF-36) is a valid and frequently used scale to evaluate HRQoL, specific for no groups of age, disorder, and treatment, includes general health concepts, and composed of 36 questions with 8 subscales as physical function, role limitation physical, role limitation emotional, bodily pain, social function, mental health, vitality, and general health. Scores of items are encoded for each subscale and formed as a scale ranging from 0 (poorest health status) to 100 (best health status). SF-36 has two summary measures as physical component scale (PCS) and mental component scale (MCS). PCS is comprised of subscales of physical function, role physical, bodily pain, and general health, and MCS is comprised of subscales of vitality, social function, role emotional, and mental health. Provide explicit instructions to parents, emphasizing that responses should reflect the child's experiences and perspectives, not only parental beliefs.	At baseline and after 4 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Arvedson, J.C., 2013. Feeding children with cerebral palsy and swallowing difficulties. European Journal of Clinical Nutrition 67, S9-S12.
• Wang, H.Y., Chen, C.C., Hsiao, S.F., 2012. Relationships between respiratory muscle strength and daily living function in children with cerebral palsy. Research in Developmental Disabilities 33, 1176-1182.
• Kwon, O., Lee, N., Shin, B., 2014. Data quality management, data usage experience and acquisition intention of big data analytics. International Journal of Information Management 34, 387-394.
• Geddes EL, O'Brien K, Reid WD, Crowe J, Brooks D.Inspiratory muscle training in adults with chronic obstructive pulmonary disease: a systematic review.Respiratory Medicine.2008;102(12):1715-1729.
• Neves, L.F., Reis, M.H., Plentz, R.D.M., Matte, D.L., Coronel, C.C., Sbruzzi, G., 2014. Expiratory and expiratory plus inspiratory muscle training improves respiratory muscle strength in subjects with COPD: Systematic review. Respiratory Care 59, 1381-1388.
• Zunzunwala, S., Vardhan, D.V., 2023. Efficacy of lung boost device on pulmonary function and chest expansion in pleural effusion patient: a randomized control trial protocol. F1000Research 12, 1115.
• Atia, D.T., Tharwat, M.M., 2021. Effect of incentive spirometer exercise combined with physical therapy on pulmonary functions in children with cerebral palsy. International Journal of Therapy and Rehabilitation 28, 1-8.
• Weiner, P.; Magadle, R.; Beckerman, M.; Weiner, M.; Berar-Yanay, N., 2004,Maintenance of inspiratory muscle training in COPD patients: One year follow-up. Eur. Respir. J. 23, 61-65.
• Chang, W.; Lin, H.C.; Liu, H.E.; Han, C.Y.; Chang, P.J., 2023. The Effectiveness of Home-Based Inspiratory Muscle Training on Small Airway Function and Disease-Associated Symptoms in Patients with Chronic Obstructive Pulmonary Disease. Healthcare, 11, 2310.
• Borges do Nascimento IJ, Cacic N, Abdulazeem HM, et al. : Novel coronavirus infection (COVID-19) in humans: a scoping review and meta-analysis. J Clin Med, 2020, 9: 941. [DOI] [PMC free article] [PubMed] [Google Scholar]
• Amisha. A. Alande, Vishnu Vardhan G.D. Effect of lung boost device on inspiratory muscle strength in abdominal surgery patients. Int J Physiother Res 2021;9(2):3793-3799. DOI: 10.16965/ijpr.2021.109
• So MW, Heo HM, Koo BS et al. Efficacy of incentive spirometer exercise on pulmonary functions of patients with ankylosing spondylitis stabilized by tumor necrosis factor inhibitor therapy. J Rheumatol. 2012;39(9):1854-1858.
• Bohannon RW, Crouch R. Minimal clinically important difference for change in 6-minute walk test distance of adults with pathology: a systematic review. J Eval Clin Pract. 2017 Apr;23(2):377-381. doi: 10.1111/jep.12629. Epub 2016 Sep 4. PMID: 27592691
• Holland A.E., Spruit M.A., Troosters T. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014;44(6):1428-1446. doi: 10.1183/09031936.00150314.
• Proesmans M. Respiratory illness in children with disability: a serious problem? Breathe (Sheff). 2016 Dec;12(4):e97-e103. doi: 10.1183/20734735.017416. PMID: 28210329; PMCID: PMC5297954.
• Stavsky M, Mor O, Mastrolia SA, Greenbaum S, Than NG, Erez O. Cerebral Palsy-Trends in Epidemiology and Recent Development in Prenatal Mechanisms of Disease, Treatment, and Prevention. Front Pediatr. 2017 Feb 13;5:21. doi: 10.3389/fped.2017.00021. PMID: 28243583; PMCID: PMC5304407.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 8, 2024

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: COVID; Cerebral palsy; incentive spirometer; Lung Boost Trainer
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: P.T.REC/012/003968

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To protect patient privacy ( must be anonymized), also need a controlled access

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No