NCT07508332: COVID-19 CP

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

Completed NA Last updated 6 April 2026

What this trial tests

NA trial testing Lung boost trainer (LBT) in Post Covid-19 in 60 participants. Completed in 8 January 2024.

Timeline

1 July 2023

Primary endpoint
1 January 2024

8 January 2024

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	1 July 2023
Primary completion	1 January 2024
Estimated completion	8 January 2024
Sites	5 locations across Egypt

Drugs / interventions tested

• Lung boost trainer (LBT)
• Incentive Spirometer Training ( IST)
• Traditional Respiratory Physical Therapy Protocol (TRPT)

Conditions studied

• Post Covid-19 — all drugs for Post Covid-19 →
• Hemiplegic — all drugs for Hemiplegic →
• CP (Cerebral Palsy) — all drugs for CP (Cerebral Palsy) →

Sponsor

Cairo University

Who can join

Adults 4 to 9, any sex, with Post Covid-19 or Hemiplegic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Lung Boost Trainer Versus Incentive Spirometer on Pulmonary Function Post COVID Hemiplegic Cerebral Palsy Children; Randomized Controlled Trial.
   Mahmoud AG, Hassan FM, Eid MA, Elkhateeb YS, et al · · 2026 · PMID 42261915 · DOI 10.1002/pri.70234