NCT04811638

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

Same day

First QC Date

March 8, 2021

Last Update Submit

August 22, 2023

Conditions

Keywords

Physical FunctionCritical İllICU Acquired Weakness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Physical Function in Intensive Care Test

    three days

Interventions

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.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients

You may qualify if:

  • Older than 18 years
  • Critical adult patients
  • Patients who were hospitalized for more than 48 hours in an ICU

You may not qualify if:

  • Unstable fracture
  • Limb deformities and dysfunction
  • Myasthenia gravis
  • Neuromuscular dysfunction
  • Patients who diagnosed COVİD-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehmet Burak Uyaroğlu

Istanbul, 34415, Turkey (Türkiye)

Location

Study Officials

  • Esra Pehlivan, Ass.Prof

    Saglik Bilimleri Universitesi

    STUDY DIRECTOR
  • Mehmet Burak Uyaroğlu, PT, MSc

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 23, 2021

Study Start

January 11, 2021

Primary Completion

January 11, 2021

Study Completion

January 14, 2021

Last Updated

August 23, 2023

Record last verified: 2023-08

Locations