StrokeNCT06573359
Turkish Validity and Reliability of the Expanded Rehabilitation Complexity Scale
An observational study of Stroke, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 6 months
- Conditions the study is for
- Stroke
- What is being tested?
- questionnaire
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Aug 2024to 7 Jan 2025
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: patients with subacute(2-6 weeks) stroke
Who may be able to join
- Clinical diagnoses of stroke -
- Exclusion Criteria: unstable cardiac and neurovascular disease
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Physical Medicine Rehabilitation Research and Training Hospital
Istanbul, Bahçelievler
cansın medin-ceylan, MD, 5315759539, cansinmedin@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- questionnaire
- Keywords
- Rehabilitation Complexity Scale; needs assessment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Turkish translation of the scale will be made by a native English speaker and the back translation will be made into English, and the consistency of the original and Turkish translation will be evaluated by a three-person expert committee. The psychometric properties of the scale will be investigated according to the methods used for the validity of the original scale. 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). will be evaluated. 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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish validation and reliability of the Rehabilitation Complexity Scale (RCS-E)
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.
Measured: 1 week for test retest interrater and intrarater evaluation. 2 months for the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start24 Aug 2024
- Primary completion26 Dec 2024 (estimated)
- Study completion7 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sedef Ersoy, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- sedef ersoy, Principal investigator, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573359
- Sponsor's protocol ID
- IstanbulPMRTRHSE
- Status last verified
- Nov 2024
- First submitted
- 24 Aug 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of the Expanded Rehabilitation Complexity Scale in Patients in the Stroke Palliative Care Unit
- ClinicalTrials.gov ID
- NCT06573359
- Acronym / sponsor ID
- IstanbulPMRTRHSE
- Conditions
- Stroke
- Keywords
- Rehabilitation Complexity Scale; needs assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 24 Aug 2024 (actual)
- Primary completion
- 26 Dec 2024 (estimated)
- Study completion
- 7 Jan 2025 (estimated)
- First posted
- 27 Aug 2024 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 2 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients with subacute(2-6 weeks) stroke
Key inclusion criteria (3 listed)
- Clinical diagnoses of stroke -
- Exclusion Criteria: unstable cardiac and neurovascular disease
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| questionnaireTurkish translation of the scale will be made by a native English speaker and the back translation will be made into English, and the consistency of the original and Turkish translation will be evaluated by a three-person expert committee. The psychometric properties of the scale will be investigated according to the methods used for the validity of the original scale. 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). will be evaluated. 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). | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: Yes
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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.
sedef ersoy principal investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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 Stroke, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 0 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: looking for participants now, as of the sponsor's last update on 8 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact sedef ersoy, MD (+905339532025, sedef_ersoy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 8 Nov 2024.