- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06518460
Functional Efficiency of Self-sufficiency Test (FEST)
Development and Testing of a New Tool for Evaluating Functional Self-sufficiency in Post-acute Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The research included the development of the FEST and its validation and the determination of the influence of selected factors on the change in functional self-sufficiency assessed by FEST.
The FEST consists of nine assessed categories (mobility, stability, locomotion, dressing, hygiene, eating, household care, communication, finances), which allow a comprehensive assessment of the current status of post-acute stroke patients. Patients meeting inclusion criteria are screened: 1/ diagnosed with ischemic or haemorrhagic stroke in the post-acute stage; 2/ aged ≥18 years; 3/ stable vital functions; 4/ rehabilitation load of 4 hours per day; 5/ maintained swallowing functions. Exclusion criteria: 1/ tracheostomy; 2/ not recommended by psychotherapist due to cognitive deficit and unwillingness; 3/ severe sensory deficit (hearing, vision). Patients are tested at the beginning (first measurement) and at the end of the post-acute rehabilitation care (second measurement) at the rehabilitation institute. The battery of tests included FEST, BI, the Action Research Arm Test (ARAT).
Descriptive statistics will use for the basic statistical analysis. Cronbach's alpha will use to assess reliability. The correlation between variables will calculate using Spearman's and Pearson's correlation coefficients and the biserial correlation coefficient. Construct validity will assess using factor analysis. The difference between independent samples will verify by two-sample t-test. The effect of baseline demographic characteristics (age, gender), and UA functional status on the improvement in the level of self-sufficiency measured by FEST will verify by multivariate linear regression. All tests will perform at a significance level of 0.05. IBM SPSS Statistics for Windows (version 23.0) statistical software will use for statistical processing (Armonk, NY: IBM Corp).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Czech
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Olomouc, Czech, Czechia, 77515
- Palacky University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- diagnosed with ischemic or haemorrhagic stroke in the post-acute stage; aged ≥18 years; stable vital functions; rehabilitation load of 4 hours per day; maintained swallowing functions.
Exclusion Criteria:
- tracheostomy; not recommended by psychotherapist due to cognitive deficit and unwillingness; severe sensory deficit (hearing, vision).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Psychometric characteristics validation
Time Frame: 1.8.2024-31.8.2025
|
The following tests will be performed on the FEST test: internal consistency, correlation between variables, convergent validity, and factor analysis.
The psychometric properties of the FEST will be compared with those of the Barthel Index and the Action Research Arm Test.
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1.8.2024-31.8.2025
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Helena Kisvetrova, Palacky University Olomouc
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 61989592
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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