Cerebral PalsyNCT05271123
Pulmonary Functions in Relation to Gross Motor Function Level
An observational study of Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Assessment of respiratory function and growth motor function classiffication level
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Uncontrolled convulsions
- Any psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Assessment of respiratory function and growth motor function classiffication level
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of respiratory function and growth motor function classiffication levelDiagnostic test
Assessment of respiratory function using spirometer and assessment of growth motor function classiffication level using GMFCs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Assessment of respiratory function and growth motor function classiffication level |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Forced expiratory volume at first second
Measured: baseline ( enrolment)
PEF
Peak Expiratory Flow Peak expiratory flow
Measured: baseline ( enrolment)
GMFCs
Growth motor functional classification level
Measured: baseline ( enrolment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Oct 2021
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Elsayed Abbass, Cairo University
- Investigators
- Mai Abbass, Ph.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271123
- Sponsor's protocol ID
- REC/012/003541
- Status last verified
- Mar 2022
- First submitted
- 13 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Functions in Relation to Gross Motor Function Level in The Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05271123
- Acronym / sponsor ID
- REC/012/003541
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Assessment of respiratory function and growth motor function classiffication levelChildren 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. |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Uncontrolled convulsions
- Any psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of respiratory function and growth motor function classiffication levelAssessment of respiratory function using spirometer and assessment of growth motor function classiffication level using GMFCs | Diagnostic test | Study group |
Primary outcome
FEV1
Time frame: baseline ( enrolment)
Forced expiratory volume at first second
PEF
Time frame: baseline ( enrolment)
Peak Expiratory Flow Peak expiratory flow
GMFCs
Time frame: baseline ( enrolment)
Growth motor functional classification level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai Abbass, Ph.D. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 (time frame: baseline ( enrolment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.