Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518460
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-03-24
Brief Title:
Functional Efficiency of Self-sufficiency Test
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development and Testing of a New Tool for Evaluating Functional Self-sufficiency in Post-acute Stroke Patients
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FEST
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 Cronbachs alpha will use to assess reliability The correlation between variables will calculate using Spearmans and Pearsons 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 005 IBM SPSS Statistics for Windows version 230 statistical software will use for statistical processing Armonk NY IBM Corp
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 Cronbachs alpha will use to assess reliability The correlation between variables will calculate using Spearmans and Pearsons 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 005 IBM SPSS Statistics for Windows version 230 statistical software will use for statistical processing Armonk NY IBM Corp
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None