- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05271123
Pulmonary Functions in Relation to Gross Motor Function Level
March 5, 2022 updated by: Mai Elsayed Abbass, Cairo University
Pulmonary Functions in Relation to Gross Motor Function Level in The Children With Cerebral Palsy
Aim: To investigate the relation between forced expiratory volume at first second and peak expiratory flow with gross motor function level in the children with cerebral palsy.
Methods and Procedures: Thirty children with cerebral palsy from both sexes were included in this study. The children ages ranged from 3 to 11 years old.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Methods and Procedures: Thirty children with cerebral palsy from both sexes were included in this study.
The children ages ranged from 3 to 11 years old.
Children were evaluated using spirometer to assess forced expiratory volume at first second and peak expiratory flow and gross motor function classification system to assess the functional level.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 11432
- Faculty of physical therapy, Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 months to 7 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
- Children with cerebral palsy
- age was from 3 to 11years old
- They were able to sit independently and to follow instructions
- Children who can blow air independently.
Description
Inclusion Criteria:
- Children with cerebral palsy
- age was from 3 to 11years old
- They were able to sit independently and to follow instructions.
- Children who can blow air independently.
Exclusion Criteria:
- Uncontrolled convulsions
- Any psychiatric disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study group
Children were evaluated using spirometer to assess forced expiratory volume at first second and peak expiratory flow and gross motor function classification system to assess the functional level.
|
Assessment of respiratory function using spirometer and assessment of growth motor function classiffication level using GMFCs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FEV1
Time Frame: baseline ( enrolment)
|
Forced expiratory volume at first second
|
baseline ( enrolment)
|
|
PEF
Time Frame: baseline ( enrolment)
|
Peak Expiratory Flow Peak expiratory flow
|
baseline ( enrolment)
|
|
GMFCs
Time Frame: baseline ( enrolment)
|
Growth motor functional classification level
|
baseline ( enrolment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mai Abbass, Ph.D., Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Actual)
November 1, 2021
Study Completion (Actual)
November 1, 2021
Study Registration Dates
First Submitted
February 13, 2022
First Submitted That Met QC Criteria
March 5, 2022
First Posted (Actual)
March 8, 2022
Study Record Updates
Last Update Posted (Actual)
March 8, 2022
Last Update Submitted That Met QC Criteria
March 5, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/012/003541
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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