NCT07498114

Brief Summary

This observational cross-sectional study aims to examine the association between fatigue severity and health-related quality of life in individuals with stroke. Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), and quality of life will be evaluated using the Nottingham Health Profile (NHP). The primary analysis will investigate the relationship between FSS total score and NHP total score and domain scores.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2026

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

Study Start

First participant enrolled

March 5, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

20 days

First QC Date

March 23, 2026

Last Update Submit

March 26, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Fatigue Severity Scale

    Fatigue Severity Scale (FSS) is a 9-item self-report questionnaire used to assess the severity of fatigue and its impact on daily functioning. Each item is scored on a 7-point Likert scale (1-7), with higher scores indicating greater fatigue severity. The FSS is a reliable and widely used measure in clinical and research settings.

    Single assessment at enrollment (baseline)

  • Nottingham Health Profile

    Nottingham Health Profile (NHP) is a self-reported questionnaire used to assess perceived health status and quality of life. It consists of 38 items covering six domains: physical mobility, pain, sleep, energy, social isolation, and emotional reactions. Higher scores indicate poorer health status.

    Single assessment at enrollment (baseline)

Study Arms (1)

Individuals with stroke meeting eligibility criteria.

No interventions will be administered

Eligibility Criteria

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

unit/community stroke follow-up\].

You may qualify if:

  • Time since stroke: ≥ \[3\] months
  • Able to understand and complete questionnaires (with/without assistance)
  • Provides informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Üsküdar Üniversitesi

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Ponchel A, Bombois S, Bordet R, Henon H. Factors Associated with Poststroke Fatigue: A Systematic Review. Stroke Res Treat. 2015;2015:347920. doi: 10.1155/2015/347920. Epub 2015 May 25.

  • Tang WK, Lu JY, Chen YK, Mok VC, Ungvari GS, Wong KS. Is fatigue associated with short-term health-related quality of life in stroke? Arch Phys Med Rehabil. 2010 Oct;91(10):1511-5. doi: 10.1016/j.apmr.2010.06.026.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

March 5, 2026

Primary Completion

March 25, 2026

Study Completion

March 25, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations