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

Inhalation Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05915494
• Other study ID #: P.T.REC/012/004529
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: June 2023
• Source: Cairo University
• Contact: Ali MA Ismail, lecturer
• Phone: 01005154209
• Email: ali.mohamed[@]pt.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• inhalation injury

Exclusion Criteria:

• brain injury

• fractures of any body part

• cardiac or chest disorders

Related Conditions & MeSH terms

• Inhalation Injury
• Respiratory Aspiration
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Cairo Unoversity	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	forced vital capacity	it is a pulmonary function test	it will be measured after 12 weeks
Secondary	forced expiatory volume at the first second of expiration	it is a pulmonary function test	it will be measured after 12 weeks
Secondary	right-side diaphragmatic excursion	it will be assessed by ultrasonographic measurements	it will be measured after 12 weeks
Secondary	left-side diaphragmatic excursion	it will be assessed by ultrasonographic measurements	it will be measured after 12 weeks
Secondary	upper chest expansion	it will be assessed by tape	it will be measured after12 weeks
Secondary	lower chest expansion	it will be assessed by tape	it will be measured after 12 weeks