NCT06518460

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

8 months

First QC Date

March 24, 2024

Last Update Submit

July 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Psychometric characteristics validation

    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.

    1.8.2024-31.8.2025

Interventions

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.

Also known as: The Barthel Index, The Action Research Arm Test

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

post-acute stroke adult patients

You may qualify if:

  • 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.

You may not qualify if:

  • tracheostomy; not recommended by psychotherapist due to cognitive deficit and unwillingness; severe sensory deficit (hearing, vision).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palacky University

Olomouc, Czech, 77515, Czechia

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Helena Kisvetrova

    Palacky University Olomouc

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD., MSc.

Study Record Dates

First Submitted

March 24, 2024

First Posted

July 24, 2024

Study Start

August 1, 2024

Primary Completion

March 31, 2025

Study Completion

April 30, 2025

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations