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

NCT ID: NCT05915494

Last Updated: 2023-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-01-15

Brief Summary

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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

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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)

Conditions

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Inhalation Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

intermittent pneumatic compression, physiotherapy, and walking

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

physiotherapy and walking

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* inhalation injury

Exclusion Criteria

* brain injury
* fractures of any body part
* cardiac or chest disorders
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ali Mohamed Ali ismail

lecturer of physical therapy for Internal Medicine and Geriatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali MA Ismail

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo Unoversity

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ali MA Ismail, lecturer

Role: CONTACT

01005154209

Ali MA Ismail, lecturer

Role: CONTACT

Facility Contacts

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Ali Ismail, lecturer

Role: primary

01005154209

Other Identifiers

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P.T.REC/012/004529

Identifier Type: -

Identifier Source: org_study_id

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