Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:50 PM
Study NCT ID:
NCT04277234
Status:
UNKNOWN
Last Update Posted:
2020-02-21
First Post:
2019-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Characterisation of Post-stroke Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2019-02-21', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue Severity Scale (FSS)', 'timeFrame': 'assessment during 1 day study visit', 'description': '9-item fatigue scale (Score/7) Minimum value = 1, Maximum value = 7 An average score greater than or equal to four signifies pathological fatigue'}], 'secondaryOutcomes': [{'measure': 'Pittsburgh Sleep quality index', 'timeFrame': 'assessment during 1 day study visit', 'description': 'Sleep assessment. The score of seven components are summed to provide a global score from 0 to 21.\n\nA global score greater than five is indicative of poor sleep'}, {'measure': 'ACTIVLIM specific to patients with stroke', 'timeFrame': 'assessment during 1 day study visit', 'description': '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.\n\nParticipants 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)'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'assessment during 1 day study visit', 'description': 'Mood assessment. Self-report questionnaire with anxiety and depression subscales, each consisting of 7 questions.\n\nScore each item from 0 (no symptoms) to 3 points (maximum impairment) The cutoff for a pathological score is ≥ 7 for each subscale'}, {'measure': '6-minute walk test', 'timeFrame': 'assessment during 1 day study visit', 'description': '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.'}, {'measure': 'Neuromuscular Fatigability Index', 'timeFrame': 'assessment during 1 day study visit', 'description': '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.\n\nA higher NMFI score indicates higher fatigability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fatigue', 'fatigability', 'functional impairment'], 'conditions': ['Stroke', 'Stroke Sequelae']}, 'referencesModule': {'references': [{'pmid': '32740873', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adults', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mini Mental State Evaluation \\> 24\n* Stroke \\> 6 months ago\n\nExclusion Criteria:\n\n* Current active infection\n* Multiple stroke\n* Other affection of the central nervous system\n* Medication potentially inducing severe fatigue\n* Hospital admission during last month\n* Severe Apraxia\n* Severe Aphasia'}, 'identificationModule': {'nctId': 'NCT04277234', 'acronym': 'PSF-SAG', 'briefTitle': 'Functional Characterisation of Post-stroke Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Functional Characterisation of Post-stroke Fatigue: a Cross-sectional Study', 'orgStudyIdInfo': {'id': 'PSF-SAG'}, 'secondaryIdInfos': [{'id': '2017/14SEP/443', 'type': 'OTHER', 'domain': 'CEHF'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Maxime Valet, MD', 'role': 'CONTACT', 'email': 'maxime.valet@uclouvain.be', 'phone': '+32 2 764 53 75'}], 'facility': 'Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Thierry Lejeune, MD', 'role': 'CONTACT', 'email': 'thierry.lejeune@uclouvain.be', 'phone': '+3227641648'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire UCLouvain Namur', 'class': 'OTHER'}, {'name': 'CHU Ambroise-Paré - Mons', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}