Validity of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx-TR) in Turkish Pediatric Intensive Care Patients

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Critical Illness; Physical Function Assessment; Functional Status; Rehabilitation

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kadıkoy
    • Istanbul, Kadıkoy, Turkey (Türkiye), 34000
      • Göztepe Prof. Dr. Süleyman Yalçın City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria

• 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
• Exclusion Criteria
• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	two measurements conducted 48 hours apart

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University
• Investigators: Study Chair: Muhterem Duyu

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 10, 2025

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: cCPAxTR2025V1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No