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

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Behavioral: Incentive spirometer training

• Registration Number: NCT02406404
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2015-03-29
• Study First Submitted QC: 2015-03-29
• Study First Posted: 2015-04-02
• Primary Completion: 2015-11-20
• Study Completion: 2015-11-20
• Status Verified: 2016-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
spirometer training group	Incentive spirometer training	incentive spirometer training group

Primary Outcome Measures

Name	Time	Method
Forced vital capacity	within 3 days after respiratory muscle training	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of