NCT06573359

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

August 24, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2024

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2025

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

August 24, 2024

Last Update Submit

November 7, 2024

Conditions

Keywords

Rehabilitation Complexity Scale; needs assessment

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 week for test retest interrater and intrarater evaluation. 2 months for the study

Interventions

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).

Eligibility Criteria

Age2 Months - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

patients with subacute(2-6 weeks) stroke

You may qualify if:

  • Clinical diagnoses of stroke -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Research and Training Hospital

Istanbul, Bahçelievler, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • sedef ersoy

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

nurdan paker, Prof.MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 24, 2024

First Posted

August 27, 2024

Study Start

August 24, 2024

Primary Completion

December 26, 2024

Study Completion

January 7, 2025

Last Updated

November 8, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
3 months

Locations