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Completed

NCT Number: NCT02406404

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incentive spirometer training

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.

Other names: exercise

Primary outcomes

  1. 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

  1. forced expiratory volume in 1 second

    Time frame: within 3 days after respiratory muscle training

  2. Peak cough flow

    Time frame: within 3 days after respiratory muscle training

  3. maximal phonation time

    Time frame: within 3 days after respiratory muscle training

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 2, 2015
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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