NCT05915494

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

7 months

First QC Date

June 13, 2023

Last Update Submit

June 13, 2023

Conditions

Inhalation Injury

Outcome Measures

Primary Outcomes (1)

  • forced vital capacity

    it is a pulmonary function test

    it will be measured after 12 weeks

Secondary Outcomes (5)

  • forced expiatory volume at the first second of expiration

    it will be measured after 12 weeks

  • right-side diaphragmatic excursion

    it will be measured after 12 weeks

  • left-side diaphragmatic excursion

    it will be measured after 12 weeks

  • upper chest expansion

    it will be measured after12 weeks

  • lower chest expansion

    it will be measured after 12 weeks

Study Arms (2)

group A

EXPERIMENTAL

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

group B

ACTIVE COMPARATOR

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

Interventions

intermittent pneumatic compression, physiotherapy, and walkingOTHER

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 A
physiotherapy and walkingOTHER

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.

group B

Eligibility Criteria

Age12 Years - 17 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of birth-certificate identity.
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • inhalation injury

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Unoversity

Giza, Egypt

RECRUITING

MeSH Terms

Interventions

Physical Therapy ModalitiesWalking

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Ali MA Ismail

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

01005154209ali.mohamed@pt.cu.edu.eg

Ali MA Ismail, lecturer

CONTACT

ali.mohamed@pt.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for Internal Medicine and Geriatrics

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 23, 2023

Study Start

July 1, 2023

Primary Completion

January 15, 2024

Study Completion

January 15, 2024

Last Updated

June 23, 2023

Record last verified: 2023-06

Locations

EG(1)