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

NCT ID: NCT07241455

Last Updated: 2026-02-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2025-12-10

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Ayse Asik

Pediatric Critical Care Fellow, Department of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhterem Duyu

Role: STUDY_CHAIR

Locations

Göztepe Prof. Dr. Süleyman Yalçın City Hospital

Istanbul, Kadıkoy, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

cCPAxTR2025V1

Identifier Type: -

Identifier Source: org_study_id