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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02406404
Enrollment
35
Registered
2015-04-02
Start date
2013-07-31
Completion date
2015-11-20
Last updated
2019-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

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.

Interventions

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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Forced vital capacitywithin 3 days after respiratory muscle trainingForced 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

MeasureTime frame
forced expiratory volume in 1 secondwithin 3 days after respiratory muscle training
Peak cough flowwithin 3 days after respiratory muscle training
maximal phonation timewithin 3 days after respiratory muscle training

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026