Pediatric Critical Illness; Physical Function Assessment; Functional Status; RehabilitationNCT07241455
Validity of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx-TR) in Turkish Pediatric Intensive Care Patients
An observational study of Pediatric Critical Illness; Physical Function Assessment; Functional Status; Rehabilitation, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This single-center, prospective observational study aims to translate, culturally adapt, and evaluate the validity and reliability of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx) in Turkish pediatric intensive care settings (cCPAx-TR). Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Pediatric Critical Illness; Physical Function Assessment; Functional Status; Rehabilitation
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 10 Dec 2025
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study will include pediatric patients aged 2 to 18 years who are admitted to the pediatric intensive care unit (PICU) at Göztepe Prof. Dr. Süleyman Yalçın City Hospital. The study population represents critically ill children with various underlying medical, surgical, and neurological conditions who are clinically stable enough to undergo bedside physical function assessment. Both intubated and non-intubated patients will be eligible for inclusion, provided that they meet stability and safety criteria for evaluation.
Who may be able to join
- Children aged 2 to 18 years
- Admitted to the pediatric intensive care unit (PICU)
- Clinically stable for bedside assessment
- Parental or guardian informed consent obtained (and child assent when appropriate)
- Able to perform or be observed for at least one item of the cCPAx-TR
Who cannot join
- Unstable hemodynamics or severe hypoxemia that prevents safe assessment
- Deep sedation or neuromuscular blockade that prevents observation at both assessments
- Severe orthopedic or neurological conditions (for example, unstable fractures or acute paralysis) that prohibit safe mobilization
- Expected death or withdrawal of care within 24 hours
- Refusal of consent by parents or guardians
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Göztepe Prof. Dr. Süleyman Yalçın City Hospital
Istanbul, Kadıkoy, 34000
About this study
This single-center, prospective observational study aims to translate, culturally adapt, and evaluate the validity and reliability of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx) in Turkish pediatric intensive care settings (cCPAx-TR). We will assess content validity with an expert panel, feasibility in a pilot run, test-retest reliability, internal consistency, and criterion validity against established clinical scores.
Read the detailed description
This single-center, prospective observational study aims to translate, culturally adapt, and evaluate the Turkish version of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx-TR) for use in pediatric intensive care settings.
The study will be conducted in the Pediatric Intensive Care Unit (PICU) of Göztepe Prof. Dr. Süleyman Yalçın City Hospital. The translation and cultural adaptation will follow internationally accepted guidelines, including forward and backward translation, expert panel review, and pilot testing.
Following pilot testing, psychometric evaluation will include assessments of internal consistency, test-retest reliability, and criterion validity by comparison with established clinical scores such as the Functional Status Scale (FSS), Glasgow Coma Scale (GCS), and Pediatric Logistic Organ Dysfunction (PELOD) score. Feasibility and safety will be analyzed based on completion rate, administration time, and occurrence of adverse events.
The study population will include children aged 2-18 years who are admitted to the PICU and are clinically stable enough for bedside physical function assessment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest intraclass correlation coefficient (ICC) - total cCPAx-TR score
The intraclass correlation coefficient (two-way mixed, absolute agreement) for the cCPAx-TR total score between two assessments administered 48 hours apart in clinically stable participants.
Measured: two measurements conducted 48 hours apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Sep 2025
- Primary completion1 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Critical Illness; Physical Function Assessment; Functional Status; RehabilitationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Asik, Goztepe Prof Dr Suleyman Yalcın City Hospital
- Investigators
- Muhterem Duyu, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241455
- Sponsor's protocol ID
- cCPAxTR2025V1
- Status last verified
- Feb 2026
- First submitted
- 17 Nov 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx-TR) in Turkish Pediatric Intensive Care Patients
- ClinicalTrials.gov ID
- NCT07241455
- Acronym / sponsor ID
- cCPAxTR2025V1
- Conditions
- Pediatric Critical Illness; Physical Function Assessment; Functional Status; Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 21 Nov 2025 (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.
This single-center, prospective observational study aims to translate, culturally adapt, and evaluate the validity and reliability of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx) in Turkish pediatric intensive care settings (cCPAx-TR). We will assess content validity with an expert panel, feasibility in a pilot run, test-retest reliability, internal consistency, and criterion validity against established clinical scores.
Detailed description
This single-center, prospective observational study aims to translate, culturally adapt, and evaluate the Turkish version of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx-TR) for use in pediatric intensive care settings.
The study will be conducted in the Pediatric Intensive Care Unit (PICU) of Göztepe Prof. Dr. Süleyman Yalçın City Hospital. The translation and cultural adaptation will follow internationally accepted guidelines, including forward and backward translation, expert panel review, and pilot testing.
Following pilot testing, psychometric evaluation will include assessments of internal consistency, test-retest reliability, and criterion validity by comparison with established clinical scores such as the Functional Status Scale (FSS), Glasgow Coma Scale (GCS), and Pediatric Logistic Organ Dysfunction (PELOD) score. Feasibility and safety will be analyzed based on completion rate, administration time, and occurrence of adverse events.
The study population will include children aged 2-18 years who are admitted to the PICU and are clinically stable enough for bedside physical function assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will include pediatric patients aged 2 to 18 years who are admitted to the pediatric intensive care unit (PICU) at Göztepe Prof. Dr. Süleyman Yalçın City Hospital. The study population represents critically ill children with various underlying medical, surgical, and neurological conditions who are clinically stable enough to undergo bedside physical function assessment. Both intubated and non-intubated patients will be eligible for inclusion, provided that they meet stability and safety criteria for evaluation.
Key inclusion criteria (5 listed)
- Children aged 2 to 18 years
- Admitted to the pediatric intensive care unit (PICU)
- Clinically stable for bedside assessment
- Parental or guardian informed consent obtained (and child assent when appropriate)
- Able to perform or be observed for at least one item of the cCPAx-TR
Key exclusion criteria (5 listed)
- Unstable hemodynamics or severe hypoxemia that prevents safe assessment
- Deep sedation or neuromuscular blockade that prevents observation at both assessments
- Severe orthopedic or neurological conditions (for example, unstable fractures or acute paralysis) that prohibit safe mobilization
- Expected death or withdrawal of care within 24 hours
- Refusal of consent by parents or guardians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Test-retest intraclass correlation coefficient (ICC) - total cCPAx-TR score
Time frame: two measurements conducted 48 hours apart
The intraclass correlation coefficient (two-way mixed, absolute agreement) for the cCPAx-TR total score between two assessments administered 48 hours apart in clinically stable participants.
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 11 Feb 2026.
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.
Muhterem Duyu study chair
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 Pediatric Critical Illness; Physical Function Assessment; Functional Status; Rehabilitation, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 11 Feb 2026. 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 Turkey (Türkiye). 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?
Test-retest intraclass correlation coefficient (ICC) - total cCPAx-TR score (time frame: two measurements conducted 48 hours apart). 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 11 Feb 2026.