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Functional Efficiency of Self-sufficiency Test

Development and Testing of a New Tool for Evaluating Functional Self-sufficiency in Post-acute Stroke Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06518460
Acronym
FEST
Enrollment
164
Registered
2024-07-24
Start date
2024-08-01
Completion date
2025-04-30
Last updated
2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke/Brain Attack

Brief summary

The aim of this study is to design and validate new tool for evaluation of self-sufficiency in post-acute stroke patients. And further identify the factors influencing changes in the Functional Efficiency of Self-sufficiency Test (FEST) in post-acute rehabilitation care.

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).

Interventions

DIAGNOSTIC_TESTFunctional Efficiency of Self-sufficiency Test

The Barthel Index has 10 items focusing on mobility, feeding, grooming, hygiene, dressing, bladder control and bowel control. It scores from 0-100 points. A higher score indicates better performance. The Action Research Arm Test is 19-item observational measure used for the assessment of UE performance in stroke recovery. Scores range from 0-57 points. A higher score indicates a better outcome.

Sponsors

Palacky University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Psychometric characteristics validation1.8.2024-31.8.2025The 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.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026