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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05252663
Other study ID # REC/012/003589
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 26, 2022
Est. completion date August 24, 2022

Study information

Verified date November 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim: To investigate the effect of intrathoracic oscillations on forced expiratory volume at first second and peak expiratory flow in the children with cerebral palsy. Methods and Procedures: Children were randomly assigned into two groups (study group and control group). Each child was evaluated before and after 6 successive weeks.


Description:

Methods and Procedures: 24 children with spastic cerebral palsy from both sexes, There ages from 6 to 8 years old. Children were randomly assigned into two groups (study group and control group). Each child was evaluated before and after 6 successive weeks. The children of the control group received traditional chest physiotherapy. while, the children of the study group received 4 sessions per week for 6 weeks with quake device.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 24, 2022
Est. primary completion date August 24, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Years to 8 Years
Eligibility Inclusion Criteria: - children with cerebral palsy - Age from 6 to 8 years old - the degree of spasticity from 2 to 2+ - grade 4, 5 according to GMFCs Exclusion Criteria: - Uncontrolled convulsions - Any psychiatric disorders

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Quake device training
In Quake breathing, patients were advised to take a deep breath and hold it for 3-5 seconds. The patient had the mouthpiece firmly sealed to the lips and were asked to inhale and exhale completely
Traditional chest physiotherapy
postural drainage - percussion

Locations

Country Name City State
Egypt Faculty of Physical Therapy, Cairo University Cairo
Egypt Faculty of physical therapy, Cairo university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary FEV1 Forced expiratory volume at first second After 6 weeks
Primary PEF Peak expiratory flow After 6 weeks
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