NCT04277234

Brief Summary

Post-stroke fatigue is highly prevalent and disabling. However, its causes and consequences in the chronic phase are not fully understood. The aim of this cross-sectional study is to explore functional correlates of post-stroke fatigue in the chronic phase.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
12 months until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

February 21, 2019

Last Update Submit

February 19, 2020

Conditions

Keywords

fatiguefatigabilityfunctional impairment

Outcome Measures

Primary Outcomes (1)

  • Fatigue Severity Scale (FSS)

    9-item fatigue scale (Score/7) Minimum value = 1, Maximum value = 7 An average score greater than or equal to four signifies pathological fatigue

    assessment during 1 day study visit

Secondary Outcomes (5)

  • Pittsburgh Sleep quality index

    assessment during 1 day study visit

  • ACTIVLIM specific to patients with stroke

    assessment during 1 day study visit

  • Hospital Anxiety and Depression Scale (HADS)

    assessment during 1 day study visit

  • 6-minute walk test

    assessment during 1 day study visit

  • Neuromuscular Fatigability Index

    assessment during 1 day study visit

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adults

You may qualify if:

  • Mini Mental State Evaluation \> 24
  • Stroke \> 6 months ago

You may not qualify if:

  • Current active infection
  • Multiple stroke
  • Other affection of the central nervous system
  • Medication potentially inducing severe fatigue
  • Hospital admission during last month
  • Severe Apraxia
  • Severe Aphasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (1)

  • Rahamatali M, De Bont N, Valet M, Halkin V, Hanson P, Deltombe T, Lejeune T, Selves C. Post-stroke fatigue: how it relates to motor fatigability and other modifiable factors in people with chronic stroke. Acta Neurol Belg. 2021 Feb;121(1):181-189. doi: 10.1007/s13760-020-01453-9. Epub 2020 Aug 1.

MeSH Terms

Conditions

StrokeFatigue

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Thierry Lejeune, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 20, 2020

Study Start

October 25, 2018

Primary Completion

March 1, 2020

Study Completion

May 1, 2020

Last Updated

February 21, 2020

Record last verified: 2020-02

Locations