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Clinical Trials/NCT02406404
NCT02406404
Completed
Not Applicable

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

Yonsei University1 site in 1 country35 target enrollmentJuly 2013
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Yonsei University
Enrollment
35
Locations
1
Primary Endpoint
Forced vital capacity
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
November 20, 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Forced vital capacity

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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