Back to resultsIntermittent-pneumatic Compression in Inhalation-injury Children: Effects on Diaphragm Mobility and Pulmonary Function
Primary Purpose
Inhalation Injury
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
intermittent pneumatic compression, physiotherapy, and walking
physiotherapy and walking
Sponsored by
About this trial
This is an interventional treatment trial for Inhalation Injury
Eligibility Criteria
Inclusion Criteria: inhalation injury Exclusion Criteria: brain injury fractures of any body part cardiac or chest disorders
Sites / Locations
- Cairo UnoversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group A
group B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
forced vital capacity
it is a pulmonary function test
Secondary Outcome Measures
forced expiatory volume at the first second of expiration
it is a pulmonary function test
right-side diaphragmatic excursion
it will be assessed by ultrasonographic measurements
left-side diaphragmatic excursion
it will be assessed by ultrasonographic measurements
upper chest expansion
it will be assessed by tape
lower chest expansion
it will be assessed by tape
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05915494
Brief Title
Intermittent-pneumatic Compression in Inhalation-injury Children: Effects on Diaphragm Mobility and Pulmonary Function
Official Title
Intermittent Pneumatic Compression in Inhalation Injury: Effects on Diaphragm Mobility and Pulmonary Function in Children Sufferers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
inhalation injury is very common in infants, young, children. complications of this problems are low pulmonary functions and limited mobility of main inspiratory muscle.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inhalation Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
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.
Arm Title
group B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
intermittent pneumatic compression, physiotherapy, and walking
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
physiotherapy and walking
Intervention Description
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.
Primary Outcome Measure Information:
Title
forced vital capacity
Description
it is a pulmonary function test
Time Frame
it will be measured after 12 weeks
Secondary Outcome Measure Information:
Title
forced expiatory volume at the first second of expiration
Description
it is a pulmonary function test
Time Frame
it will be measured after 12 weeks
Title
right-side diaphragmatic excursion
Description
it will be assessed by ultrasonographic measurements
Time Frame
it will be measured after 12 weeks
Title
left-side diaphragmatic excursion
Description
it will be assessed by ultrasonographic measurements
Time Frame
it will be measured after 12 weeks
Title
upper chest expansion
Description
it will be assessed by tape
Time Frame
it will be measured after12 weeks
Title
lower chest expansion
Description
it will be assessed by tape
Time Frame
it will be measured after 12 weeks
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
based on self-representation of birth-certificate identity.
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
inhalation injury
Exclusion Criteria:
brain injury
fractures of any body part
cardiac or chest disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali MA Ismail, lecturer
Phone
01005154209
Email
ali.mohamed@pt.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ali MA Ismail, lecturer
Email
ali.mohamed@pt.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali MA Ismail
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo Unoversity
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
01005154209
Email
allooka2012@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Intermittent-pneumatic Compression in Inhalation-injury Children: Effects on Diaphragm Mobility and Pulmonary Function
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