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

NCT02406404 | Completed

• 1 other identifier: 1-2013-0031
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• 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.

  within 3 days after respiratory muscle training

Secondary Outcomes (3)

• 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 Arms (2)

spirometer training group

EXPERIMENTAL

incentive spirometer training group

Behavioral: Incentive spirometer training

No intervention group

NO INTERVENTION

no intervention group

Interventions

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.

Also known as: exercise

spirometer training group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2015
• First Posted: April 2, 2015
• Study Start: July 1, 2013
• Primary Completion: November 20, 2015
• Study Completion: November 20, 2015
• Last Updated: March 29, 2019

Record last verified: 2016-03

Locations

KR (1)