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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07241455

Enrollment

Registered

2025-11-21

Start date

2025-09-01

Completion date

2025-12-10

Last updated

2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Test-retest intraclass correlation coefficient (ICC) - total cCPAx-TR score	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.

Countries

Turkey (Türkiye)

Contacts

STUDY_CHAIRMuhterem Duyu

Outcome results