Change of Pulmonary Function After Incentive Spirometer Training in Children With Cerebral Palsy

Study Overview
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Brief Summary
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This study was designed to examine the effect of incentive spirometry in pulmonary rehabilitation of children with cerebral palsy. The incentive spirometer, a device that can help improve breathing and strengthen inspiratory muscles. If the patient assigned to training group, the subjects started to respiratory muscle strengthening exercise using incentive spirometry. The training was performed ten sessions daily, for 4 weeks. Respiratory function tests including forced vital capacity, forced expiratory volume in 1 second, Peak cough flow, maximal phonation time were compared before interventions and at the end of exercise.

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Behavioral: Incentive spirometer training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female, 4 to 18 years patients who are committed to comply with protocol-required procedures GMFCS (Gross motor function classification system) level II, III, IV Stable medical condition in the investigator's opinion Acceptable chest radiologic result who has no evidence of pulmonary disease Exclusion Criteria: Any uncontrolled clinically significant medical condition other than the one under study Patients with cognitive impairment who are unable to comply with protocol-required procedure Patients with presence or history of tracheostomy Patients who are taking medications that can affect respiratory function

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: spirometer training group<br>incentive spirometer training group | Behavioral: Incentive spirometer training<br>* The incentive spirometer, a device that can help improve breathing and strengthen inspiratory muscles. First, the subjects exhaled normally, then placed the mouthpiece in their mouth and sealed their lips around the mouthpiece. Then they inhaled slowly and deeply with their lips sealed tightly on the mouthpiece. After they inhaled as deeply as possible, held their breath for at least 3 seconds, and then removed the mouthpiece from their mouth and breathed out normally. Subjects repeated this technique 10-15 times. When they finished 10-15 exercises, they took a deep breath and coughed. The training was performed ten sessions daily, for 4 weeks.<br>* Other names: exercise;|
| No Intervention: No intervention group<br>no intervention group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced vital capacity | Forced vital capacity means amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Measuring FVC is done through spirometry testing. | within 3 days after respiratory muscle training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| forced expiratory volume in 1 second |  | within 3 days after respiratory muscle training | 
| Peak cough flow |  | within 3 days after respiratory muscle training | 
| maximal phonation time |  | within 3 days after respiratory muscle training |