Intermittent-pneumatic Compression in Inhalation-injury Children: Effects on Diaphragm Mobility and Pulmonary Function

June 13, 2023 updated by: Ali Mohamed Ali ismail, Cairo University

Intermittent Pneumatic Compression in Inhalation Injury: Effects on Diaphragm Mobility and Pulmonary Function in Children Sufferers

inhalation injury is very common in infants, young, children. complications of this problems are low pulmonary functions and limited mobility of main inspiratory muscle.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

inhalation injury patients (children, n = 40) will be included in intermittent pneumatic compression group (n = 20, this device, intermittent pneumatic compression, will be used a resistive inspiratory muscle training for diaphragm muscle and the 10-set training will be done five session per the week, for 12 weeks. besides this training, traditional physical therapy program will be handled). In other inhalation group, n =20, traditional physical therapy program will be handled only)

Study Type

Interventional

Enrollment (Estimated)

40

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 Contact

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Cairo Unoversity
        • Contact:

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • inhalation injury

Exclusion Criteria:

  • brain injury
  • fractures of any body part
  • cardiac or chest disorders

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A
intermittent pneumatic compression group (n = 20 inhalation injury children). in this children group, intermittent pneumatic compression will be used to resist diaphragm muscle during 10-set-training session which will be done five session per the week, for 12 weeks. besides this training, traditional physical therapy program will be handled). In other inhalation group, n =20, traditional physical therapy program will be handled only). Also, free walking for 30 minutes daily will be performed by children.
Other: intermittent pneumatic compression, physiotherapy, and walking
intermittent pneumatic compression group (n = 20 inhalation injury children). in this children group, intermittent pneumatic compression will be used to resist diaphragm muscle during 10-set-training session which will be done five session per the week, for 12 weeks. besides this training, traditional physical therapy program will be handled). In other inhalation group, n =20, traditional physical therapy program will be handled only). Also, free walking for 30 minutes daily will be performed by children.
Active Comparator: group B
traditional physiotherapy group (n = 20 inhalation injury children). In this inhalation group, traditional physical therapy program will be handled only for 12 weeks. Also, free walking for 30 minutes daily will be performed by children.
Other: physiotherapy and walking
in this children group, n = 20, for 12 weeks, traditional physical therapy program (chest physical therapy, flexibility exercises, range of motion exercises) will be handled. Also, free walking for 30 minutes daily will be performed by children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
forced vital capacity
Time Frame: it will be measured after 12 weeks
it is a pulmonary function test
it will be measured after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
forced expiatory volume at the first second of expiration
Time Frame: it will be measured after 12 weeks
it is a pulmonary function test
it will be measured after 12 weeks
right-side diaphragmatic excursion
Time Frame: it will be measured after 12 weeks
it will be assessed by ultrasonographic measurements
it will be measured after 12 weeks
left-side diaphragmatic excursion
Time Frame: it will be measured after 12 weeks
it will be assessed by ultrasonographic measurements
it will be measured after 12 weeks
upper chest expansion
Time Frame: it will be measured after12 weeks
it will be assessed by tape
it will be measured after12 weeks
lower chest expansion
Time Frame: it will be measured after 12 weeks
it will be assessed by tape
it will be measured after 12 weeks

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Ali MA Ismail, Cairo 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 (Estimated)

July 1, 2023

Primary Completion (Estimated)

January 15, 2024

Study Completion (Estimated)

January 15, 2024

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004529

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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