Clinical trial NCT06518460: Functional Efficiency of Self-sufficiency Test
Official title: Development and Testing of a New Tool for Evaluating Functional Self-sufficiency in Post-acute Stroke Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke/Brain Attack
Lead sponsor: Palacky University
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: post-acute stroke adult patients

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).

Eligibility criteria: 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).

Primary outcomes:
measure: Psychometric characteristics validation
timeFrame: 1.8.2024-31.8.2025
Secondary outcomes:
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: Palacky University
state: Czech
Study officials:
affiliation: Palacky University Olomouc
name: Helena Kisvetrova
role: STUDY_DIRECTOR
References: