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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04277234
Other study ID # PSF-SAG
Secondary ID 2017/14SEP/443
Status Recruiting
Phase
First received
Last updated
Start date October 25, 2018
Est. completion date May 2020

Study information

Verified date February 2020
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact Thierry Lejeune, MD
Phone +3227641648
Email thierry.lejeune@uclouvain.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 2020
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Mini Mental State Evaluation > 24

- Stroke > 6 months ago

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium Cliniques universitaires Saint-Luc Bruxelles

Sponsors (3)

Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain Centre Hospitalier Universitaire Dinant Godinne - UCL Namur, CHU Ambroise-Paré - Mons

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Pittsburgh Sleep quality index Sleep assessment. The score of seven components are summed to provide a global score from 0 to 21.
A global score greater than five is indicative of poor sleep
assessment during 1 day study visit
Secondary ACTIVLIM specific to patients with stroke Rasch-validated activity assessment. Self-report 20-item questionnaire based on the International Classification of Functioning, Disability and Health and includes activities related to self-care, transfer, mobility, manual ability and balance.
Participants have to evaluate the perceived difficulty of performing each activity if realised without technical or human assistance. Each item has three response possibilities (impossible, difficult, easy)
assessment during 1 day study visit
Secondary Hospital Anxiety and Depression Scale (HADS) Mood assessment. Self-report questionnaire with anxiety and depression subscales, each consisting of 7 questions.
Score each item from 0 (no symptoms) to 3 points (maximum impairment) The cutoff for a pathological score is = 7 for each subscale
assessment during 1 day study visit
Secondary 6-minute walk test Speed decrement (distance first minute - distance last minute). The distance walked each minute and the total distance walked were measured. Performance fatigability was assessed by the difference of distance walked during the first and sixth minutes. assessment during 1 day study visit
Secondary Neuromuscular Fatigability Index Decrement in isometric strength of knee extensors during fatiguing task The NMFI is calculated by the difference between the putative torque-versus-time curve if the subject had maintained the maximal torque recorded during the first 5 seconds for 45 seconds, considered as a score of 100 arbitrary units, and the actual area under the torque-versus-time curve.
A higher NMFI score indicates higher fatigability
assessment during 1 day study visit
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