Lung Boost Trainer Versus Incentive Spirometer on Spiro-metric Indices in Post COVID-19 Hemiplegic Cerebral Palsy Children; Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Pulmonary function test (PFT) :
研究概览
简要总结
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:
- forced expiratory volume at first second (FEV1%),
- the forced vital capacity (FVC %),
- FEV1/ FVC ratio
- 6minute walk test (6MWT)
- 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:
- 60 patients from both genders.
- spastic CP patients between the ages 4 and 9 years.
- Reasonable cognitive functions and a reasonable IQ so as to be able to follow instructions.
- after two weeks of COVID19 recovery
Participants excluded if :
- Had other psychiatric and/or neurological disorders than cerebral palsy as Seizures.
- Had any spinal deformities that affect chest mobility or pulmonary functions
- Had medical conditions that could affect respiratory function such as cardiac disease or Chronic respiratory disease or on medications that affect respiratory function
详细描述
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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 .
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Inspiratory Muscle Training (IMT) helps to reduce the level of dyspnea and improves the pulmonary function, respiratory muscle strength and functional capacity.
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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.
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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.
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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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Allocation concealment was accomplished with sealed, opaque, sequentially numbered envelopes. Each envelope was stamped according to a randomized timetable, and the envelopes were opened only after a child was enrolled, prohibiting prior knowledge of impending tasks. The researcher in charge of stamping and handling the envelopes played no role in the clinical assessment or delivery of therapies. All measurements were performed by an independent evaluator who was unaware of the group assignments or study objectives. The assessor did not have access to medical data and assessed dependent variables under similar blind settings before and after the intervention. All randomized children finished the study and were examined in their original groups. The final analyses used the intention-to-treat principle, resulting in a complete dataset without missing outcome values.
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 patients from both genders.
- •spastic CP patients between the ages 4 and 9 years.
- •Reasonable cognitive functions and a reasonable IQ so as to be able to follow instructions.
- •after two weeks of COVID19 recovery
排除标准
- •Had other psychiatric and/or neurological disorders than cerebral palsy as Seizures.
- •Had any spinal deformities that affect chest mobility or pulmonary functions
- •Had medical conditions that could affect respiratory function such as cardiac disease or Chronic respiratory disease or on medications that affect respiratory function
研究组 & 干预措施
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.
干预措施: Traditional Respiratory Physical Therapy Protocol (TRPT) (Other)
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
干预措施: Lung boost trainer (LBT) (Device)
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.
干预措施: Incentive Spirometer Training ( IST) (Device)
结局指标
主要结局
Pulmonary function test (PFT) :
时间窗: At baseline and after 4 weeks
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: 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. 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.
forced vital capacity (FVC%)
时间窗: at baseline and after 4 weeks
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.
Forced expiratory volume (FEV1%):
时间窗: at baseline and after 4 weeks
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.
FEV1/FVC ratio :
时间窗: at baseline and after 4 weeks
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.
次要结局
- Six-minute walk test (6MWT)(At baseline and after 4 weeks)
- Short form 36 (SF-36)(At baseline and after 4 weeks)
研究者
Yasmin Safwat Elkhateeb
Lecturer , designing, conducting and executing the clinical trial
Cairo University