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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04811638
Other study ID # Saglik Bilimleri University
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 11, 2021
Est. completion date January 14, 2021

Study information

Verified date August 2023
Source Saglik Bilimleri Universitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is aimed at providing an translation and cross-cultural adaptation of Chelsea Critical Care Physical Assesment Tool (CPAx) and tested its reliability and validity.


Description:

Survival has increased in the ICU due to technological developments , but physical disability after discharge has become an important problem. İntensive Care Unit Acquired Weakness(ICU-AW) is seen in most of the patients admitted in this unit. The biggest reasons for ICU-AW are; sepsis, multiple organ failure and prolonged mechanical ventilation. The use of measurement tools to evaluate disabilities during stay and after discharge in intensive care unit, is a subject that has been researched all over the world.. These measurement tools provide; monitoring and evaluation during the ICU admission and assessment efficacy of treatment in the unit. The Chelsea Critical Care Physical Assessment Tool(CPAX) has been shown to valid, reliable and to exhibited strong clinimetric properties. CPAx is a numerical measurement tool, rated according to the 6-point Guttman Scale, from complete dependence to independence and consist of ten physical function parameters. This study is aimed at providing an translation and cross-cultural adaptation of Chelsea Critical Care Physical Assesment Tool (CPAx) and tested its reliability and validity. The protocol includes a pre-test of the Turkish version on 10 patients, a final revision, and a validation on a sample of 40 İCU patients.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 14, 2021
Est. primary completion date January 11, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Older than 18 years - Critical adult patients - Patients who were hospitalized for more than 48 hours in an ICU Exclusion Criteria: - Unstable fracture - Limb deformities and dysfunction - Myasthenia gravis - Neuromuscular dysfunction - Patients who diagnosed COVID-19

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Validation of the Chelsea Critical Care Physical Assesment Tools
The validation of the CPAX tools will focus on the validity of constructs, internal consistency reliability and test-retest reliability. PFIT used for criterion validity.

Locations

Country Name City State
Turkey Mehmet Burak Uyaroglu I?stanbul

Sponsors (2)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi Medical Park Hospital Istanbul

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chelsea Critical Care Physical Assesment Tools The Chelsea critical care physical assessment (CPAx) is a measurement tool used to assess physical function in the ICU. The Chelsea critical care physical assessment (CPAx) tool is an outcome measure designed to assess 10 domains of physical ability: respiratory function, cough, bed mobility, supine to sitting on the edge of the bed, dynamic sitting, sit to stand, standing balance, transferring from bed to chair, stepping and grip strength.
The validation of the CPAX tools will focus on the validity of constructs, internal consistency reliability and test-retest reliability.
three days
Secondary Physical Function in Intensive Care Test The PFIT is a test that measures function status of patients with a variety of conditions in the ICU. It includes 5 items: amount of assistance for sit-to-stand transfers, strength for shoulder flexion, strength for knee extension, marching in place, and an upper extremity endurance task of arm elevation to 90 degrees of shoulder flexion.
PFIT used for criterion validity.
three days
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