The Validity and Reliability Study of the Chelsea Critical Care Physical Assesment Tool

August 22, 2023 updated by: Mehmet Burak Uyaroğlu, Saglik Bilimleri Universitesi

The Validity and Reliability of the Turkish Version of the Chelsea Critical Care Physical Assesment Tool

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • İ̇stanbul, Turkey, 34415
        • Mehmet Burak Uyaroğlu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

ICU patients

Description

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 COVİD-19

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Chelsea Critical Care Physical Assesment Tools
Time Frame: three days

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physical Function in Intensive Care Test
Time Frame: three days

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical Park Hospital Istanbul

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Esra Pehlivan, Ass.Prof, Saglik Bilimleri Universitesi
  • Principal Investigator: Mehmet Burak Uyaroğlu, PT, MSc, Saglik Bilimleri Universitesi
  • Study Chair: Sümeyye Akcay, PT, MSc, Saglik Bilimleri Universitesi
  • Study Chair: Gamze Koyutürk, PT, MSc, Saglik Bilimleri Universitesi
  • Study Chair: Hakan Parlak, MD, Istinye University Bahcesehir Hospital
  • Study Chair: Kürsat Baydilli, PhD, Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 11, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Saglik Bilimleri University (Saglik Bilimleri University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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