Back to resultsChange of Pulmonary Function After Incentive Spirometer Training in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Incentive spirometer training
Sponsored by
About this trial
This is an interventional supportive care trial for Cerebral Palsy
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
Sites / Locations
- Severance hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
spirometer training group
No intervention group
Arm Description
incentive spirometer training group
no intervention group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
forced expiratory volume in 1 second
Peak cough flow
maximal phonation time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02406404
Brief Title
Change of Pulmonary Function After Incentive Spirometer Training in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
November 20, 2015 (Actual)
Study Completion Date
November 20, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
spirometer training group
Arm Type
Experimental
Arm Description
incentive spirometer training group
Arm Title
No intervention group
Arm Type
No Intervention
Arm Description
no intervention group
Intervention Type
Behavioral
Intervention Name(s)
Incentive spirometer training
Other Intervention Name(s)
exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Forced vital capacity
Description
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.
Time Frame
within 3 days after respiratory muscle training
Secondary Outcome Measure Information:
Title
forced expiratory volume in 1 second
Time Frame
within 3 days after respiratory muscle training
Title
Peak cough flow
Time Frame
within 3 days after respiratory muscle training
Title
maximal phonation time
Time Frame
within 3 days after respiratory muscle training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Change of Pulmonary Function After Incentive Spirometer Training in Children With Cerebral Palsy
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