Pilot Study of Efficacy of Mechanical Insufflation Exsufflation in Stroke

NCT02080806 | Completed DMC

• 2 other identifiers: HC 13OISE0066_3BCMC13AH06
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke patients with dysphagia have restrictive lung dysfunction and impaired cough response. This pilot study was performed to determine if Mechanical Insufflation Exsufflation (MIE) therapy can help recover impaired cough function.

Conditions

Stroke; Dysphagia

Keywords

stroke, dysphagia, cough, mechanical insufflation exsufflation

Outcome Measures

Primary Outcomes (1)

• Coughing force as assessed by peak cough flow meter

  baseline, 2 weeks

Secondary Outcomes (2)

• Maximal inspiratory and expiratory pressure

  baseline- 2 weeks

• Cough force during reflexive cough test

  baseline, 2 weeks

Other Outcomes (1)

• Incidence of pneumonia

  baseline 2 weeks

Study Arms (1)

Mechanical insufflation exsufflation

ACTIVE COMPARATOR

Application of cough assist machine as part of the regular physiotherapy

Device: Mechanical Insufflation Exsufflation

Interventions

Mechanical Insufflation Exsufflation DEVICE

Mechanical Insufflation Exsufflation -Each patient received daily treatments by means of a light-weight, elastic oronasal mask. Treatments were divided between morning and afternoon and were carried out 5 times a week. A total of 20 sessions were carried out by a a trained respiratory therapist.

Mechanical insufflation exsufflation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Previous history of chronic respiratory dysfunction or other systemic disorders that may impair respiratory function (ex,rheumatoid arthritis, chronic renal disorder, spinal cord injury) Episodes of diaphragm weakness due to peripheral polyneuropathy or phrenic nerve injury Concomitant diagnosis of myopathy, muscular dystrophy, or other neurodegenerative disorders.
• Episodes of rib fracture within one year of enrollment. Chronic alcoholism Diagnosis of bullous emphysema Diagnosis of chronic renal failure

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

Bucheon St Mary's Hospital

Bucheon-si, South Korea

Location

MeSH Terms

Conditions

Stroke; Deglutition Disorders; Cough

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sun Im

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 6, 2014
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 24, 2014

Record last verified: 2014-12

Locations

KR (1)