NCT05271123

Brief 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. The children ages ranged from 3 to 11 years old.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
Last Updated

March 8, 2022

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

February 13, 2022

Last Update Submit

March 5, 2022

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (3)

  • FEV1

    Forced expiratory volume at first second

    baseline ( enrolment)

  • PEF

    Peak Expiratory Flow Peak expiratory flow

    baseline ( enrolment)

  • GMFCs

    Growth motor functional classification level

    baseline ( enrolment)

Study Arms (1)

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.

Diagnostic Test: Assessment of respiratory function and growth motor function classiffication level

Interventions

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

Eligibility Criteria

Age3 Years - 11 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Uncontrolled convulsions
  • Any psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Cairo, 11432, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mai Abbass, Ph.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Mai Elsayed Abbass, Lecturer of pediatric physical therapy

Study Record Dates

First Submitted

February 13, 2022

First Posted

March 8, 2022

Study Start

October 1, 2021

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

March 8, 2022

Record last verified: 2022-03

Locations

EG(1)