ICU PatientsNCT04811638
The Validity and Reliability Study of the Chelsea Critical Care Physical Assesment Tool
An observational study of ICU Patients and ICU Acquired Weakness, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ICU Patients, ICU Acquired Weakness
- What is being tested?
- Validation of the Chelsea Critical Care Physical Assesment Tools
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jan 2021to 14 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients
Who may be able to join
- Older than 18 years
- Critical adult patients
- Patients who were hospitalized for more than 48 hours in an ICU
Who cannot join
- Unstable fracture
- Limb deformities and dysfunction
- Myasthenia gravis
- Neuromuscular dysfunction
- Patients who diagnosed COVİD-19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- ICU Patients, ICU Acquired Weakness
- Being tested
- Validation of the Chelsea Critical Care Physical Assesment Tools
- Keywords
- Physical Function, Critical İll, ICU Acquired Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of the Chelsea Critical Care Physical Assesment ToolsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three days
Secondary outcomes (1)
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.
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start11 Jan 2021
- Primary completion11 Jan 2021
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU PatientsStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Park Hospital Istanbul
- Responsible party
- Principal investigator, Mehmet Burak Uyaroğlu, Saglik Bilimleri Universitesi
- Investigators
- Esra Pehlivan, Ass.Prof, Study director, Saglik Bilimleri UniversitesiMehmet Burak Uyaroğlu, PT, MSc, Principal investigator, Saglik Bilimleri UniversitesiSümeyye Akcay, PT, MSc, Study chair, Saglik Bilimleri UniversitesiGamze Koyutürk, PT, MSc, Study chair, Saglik Bilimleri UniversitesiHakan Parlak, MD, Study chair, Istinye University Bahcesehir HospitalKürsat Baydilli, PhD, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811638
- Sponsor's protocol ID
- Saglik Bilimleri University
- Status last verified
- Aug 2023
- First submitted
- 8 Mar 2021
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of the Turkish Version of the Chelsea Critical Care Physical Assesment Tool
- ClinicalTrials.gov ID
- NCT04811638
- Acronym / sponsor ID
- Saglik Bilimleri University
- Conditions
- ICU Patients, ICU Acquired Weakness
- Keywords
- Physical Function, Critical İll, ICU Acquired Weakness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Medical Park Hospital Istanbul
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients
Key inclusion criteria (3 listed)
- Older than 18 years
- Critical adult patients
- Patients who were hospitalized for more than 48 hours in an ICU
Key exclusion criteria (5 listed)
- Unstable fracture
- Limb deformities and dysfunction
- Myasthenia gravis
- Neuromuscular dysfunction
- Patients who diagnosed COVİD-19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validation of the Chelsea Critical Care Physical Assesment ToolsThe validation of the CPAX tools will focus on the validity of constructs, internal consistency reliability and test-retest reliability. PFIT used for criterion validity. | Other | – |
Primary outcome
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.
1 secondary outcome
Physical Function in Intensive Care Test
Time frame: three days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Pehlivan, Ass.Prof study director
Saglik Bilimleri Universitesi
Mehmet Burak Uyaroğlu, PT, MSc principal investigator
Saglik Bilimleri Universitesi
Sümeyye Akcay, PT, MSc study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU Patients and ICU Acquired Weakness, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chelsea Critical Care Physical Assesment Tools (time frame: three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.