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

March 27, 2019 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: spirometer training group
incentive spirometer training group
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.
Other Names:
  • exercise
No Intervention: No intervention group
no intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 3 days after respiratory muscle training

Secondary Outcome Measures

Outcome Measure
Time Frame
forced expiratory volume in 1 second
Time Frame: within 3 days after respiratory muscle training
within 3 days after respiratory muscle training
Peak cough flow
Time Frame: within 3 days after respiratory muscle training
within 3 days after respiratory muscle training
maximal phonation time
Time Frame: within 3 days after respiratory muscle training
within 3 days after respiratory muscle training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

November 20, 2015

Study Completion (Actual)

November 20, 2015

Study Registration Dates

First Submitted

March 29, 2015

First Submitted That Met QC Criteria

March 29, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2013-0031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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