ClinicalTrials.Veeva

Menu

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

I

Istanbul Medeniyet University

Status

Enrolling

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT07241455
cCPAxTR2025V1

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial contacts and locations

1

Loading...

Central trial contact

Muhterem Duyu, MD; Ayşe Aşık, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems