- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06573359
Turkish Validity and Reliability of the Expanded Rehabilitation Complexity Scale
November 7, 2024 updated by: Sedef Ersoy, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Turkish Validity and Reliability of the Expanded Rehabilitation Complexity Scale in Patients in the Stroke Palliative Care Unit
The RCS is a tool that can assess the need for complex rehabilitation and objectively indicate that a patient may have difficulty functioning well at home or in the community if their medical needs are still high.
Among rehabilitation patients, there are still patients with complex needs, even though they have maximized rehabilitation potential.
Moreover, RCS can also be useful in highlighting cases of patients becoming seriously ill during the rehabilitation process due to an acute illness such as sepsis, which significantly limits treatment time.
This information can be emphasized using RCS data when requesting extended or increased rehabilitation support.
Study Overview
Detailed Description
The Rehabilitation Complexity Scale (RCS) is similarly designed to provide a simple measure of the complexity of rehabilitation needs and/or interventions; This can be implemented in a timely manner and takes into account essential care, specialist nursing, therapy and medical interventions.
Clauses in the RCS state that care, nursing, therapy and medical input needs are the primary 'causes' of case complexity and (together with length of stay) will ultimately affect a particular individual.
Compliance in healthcare processes is a very current issue, with particular emphasis on the individualization of rehabilitation settings.
Compliance has been described by WHO as a complex issue with various dimensions and definitions, and these vary between countries.
However, most definitions of appropriateness address a set of basic requirements: that care be effective (based on valid evidence); be efficient (cost-effective); and is consistent with the ethical principles and preferences of the individual, society or society concerned.
It is thought that RCS will meet these needs.The research population will be 110 patients selected from the patients hospitalized in the palliative unit of Istanbul Physical Therapy and Rehabilitation Hospital.The sample size was determined as 110.
MEDCALC program was used in the analysis.
Linear regression analysis was performed.
Cronbach-alpha was calculated as 97%.Stabil subacute stroke patients will be included in the study.
Barthel, FIM, RCS-E tools will be used in the study.
Study Type
Observational
Enrollment (Estimated)
110
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
- Name: sedef ersoy, MD
- Phone Number: +905339532025
- Email: sedef_ersoy@yahoo.com
Study Contact Backup
- Name: nurdan paker, Prof.MD
- Phone Number: +905326917591
- Email: nurdanpaker@hotmail.com
Study Locations
-
-
Bahçelievler
-
Istanbul, Bahçelievler, Turkey
- Recruiting
- Istanbul Physical Medicine Rehabilitation Research and Training Hospital
-
Contact:
- cansın medin-ceylan, MD
- Phone Number: 5315759539
- Email: cansinmedin@hotmail.com
-
-
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
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients with subacute(2-6 weeks) stroke
Description
Inclusion Criteria:
Clinical diagnoses of stroke -
Exclusion Criteria: unstable cardiac and neurovascular disease
-
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Turkish validation and reliability of the Rehabilitation Complexity Scale (RCS-E)
Time Frame: 1 week for test retest interrater and intrarater evaluation. 2 months for the study
|
The validity of the scale was validated by analyzing the correlations between the rcs-e-tr score obtained at admission (both for each partial item and the total score) and other suitability indicators used in Turkey (FIM Motor and Barthel) using Spearman's rank correlation coefficient r (rho).
Additionally, to check the ability of rcs-e-tr to capture case complexity, it will be correlated with other scores usually recorded in our rehabilitation services on admission, using Spearman's rank correlation coefficient r(rho).
Files will be viewed simultaneously and independently in a blinded manner by three researchers to assess the reproducibility of the scale.
|
1 week for test retest interrater and intrarater evaluation. 2 months for the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: sedef ersoy, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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)
August 24, 2024
Primary Completion (Estimated)
December 26, 2024
Study Completion (Estimated)
January 7, 2025
Study Registration Dates
First Submitted
August 24, 2024
First Submitted That Met QC Criteria
August 24, 2024
First Posted (Actual)
August 27, 2024
Study Record Updates
Last Update Posted (Estimated)
November 8, 2024
Last Update Submitted That Met QC Criteria
November 7, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstanbulPMRTRHSE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Time Frame
3 months
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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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