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

Cerebral Palsy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406404
• Other study ID #: 1-2013-0031
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: November 20, 2015

Study information

• Verified date: March 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 20, 2015
• Est. primary completion date: November 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Behavioral:
• Incentive spirometer training
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.

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	forced expiratory volume in 1 second		within 3 days after respiratory muscle training
Secondary	Peak cough flow		within 3 days after respiratory muscle training
Secondary	maximal phonation time		within 3 days after respiratory muscle training