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

NCT ID: NCT02406404

Last Updated: 2019-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-11-20

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

spirometer training group

incentive spirometer training group

Group Type: EXPERIMENTAL

Incentive spirometer training

Intervention Type: BEHAVIORAL

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.

No intervention group

no intervention group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

exercise

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1-2013-0031

Identifier Type: -

Identifier Source: org_study_id