Back to resultsEffect of Intrathorathic Oscillations on Pulmonary Functions in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Quake device training
Traditional chest physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
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
Sites / Locations
- Faculty of Physical Therapy, Cairo University
- Faculty of physical therapy, Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study group
Control group
Arm Description
Quake breathing, patients were advised to take a deep breath and hold it for 3-5 seconds.
Percussion, vibration and shaking were used accompanied with postural drainage.
Outcomes
Primary Outcome Measures
FEV1
Forced expiratory volume at first second
PEF
Peak expiratory flow
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05252663
Brief Title
Effect of Intrathorathic Oscillations on Pulmonary Functions in Children With Cerebral Palsy
Official Title
Effect of Intrathorathic Oscillations on Pulmonary Functions in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 26, 2022 (Actual)
Primary Completion Date
August 24, 2022 (Actual)
Study Completion Date
August 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Quake breathing, patients were advised to take a deep breath and hold it for 3-5 seconds.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Percussion, vibration and shaking were used accompanied with postural drainage.
Intervention Type
Procedure
Intervention Name(s)
Quake device training
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Traditional chest physiotherapy
Intervention Description
postural drainage - percussion
Primary Outcome Measure Information:
Title
FEV1
Description
Forced expiratory volume at first second
Time Frame
After 6 weeks
Title
PEF
Description
Peak expiratory flow
Time Frame
After 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai Abbass, Ph.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy, Cairo University
City
Cairo
ZIP/Postal Code
11432
Country
Egypt
Facility Name
Faculty of physical therapy, Cairo university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Intrathorathic Oscillations on Pulmonary Functions in Children With Cerebral Palsy
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