Functional Efficiency of Self-sufficiency Test

Recruiting

• Conditions: Stroke/Brain Attack

• Registration Number: NCT06518460
• Lead Sponsor: Palacky University

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).

Study Timeline

• Study First Submitted: 2024-03-24
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Study First Posted: 2024-07-24
• Last Update Posted: 2024-07-24
• Study Start: 2024-08-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychometric characteristics validation	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.

Trial Locations

Locations (1)

Palacky University; 🇨🇿 Olomouc, Czech, Czechia