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

NCT07241455 | Completed

• 1 other identifier: cCPAxTR2025V1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Pediatric Critical Illness; Physical Function Assessment; Functional Status; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Göztepe Prof. Dr. Süleyman Yalçın City Hospital

Istanbul, Kadıkoy, 34000, Turkey (Türkiye)

Location

Study Officials

• Muhterem Duyu

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Critical Care Fellow, Department of Pediatrics

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 10, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

TU (1)