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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05915494

Collaborator

(none)

Enrollment

Location

Arms

6.5

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inhalation Injury	Other: intermittent pneumatic compression, physiotherapy, and walking Other: physiotherapy and walking	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jan 15, 2024

Anticipated Study Completion Date :

Jan 15, 2024

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

forced vital capacity [it will be measured after 12 weeks]
it is a pulmonary function test

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

inhalation injury

Exclusion Criteria:

brain injury
fractures of any body part
cardiac or chest disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo Unoversity	Giza		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Ali MA Ismail, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ali Mohamed Ali ismail, lecturer of physical therapy for Internal Medicine and Geriatrics, Cairo University

ClinicalTrials.gov Identifier:

NCT05915494

Other Study ID Numbers:

P.T.REC/012/004529

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Aspiration

Wounds and Injuries

Study Results

No Results Posted as of Jun 23, 2023