protocolSection identificationModule nctId: NCT06368323, orgStudyIdInfo id: H-01-24-9931, briefTitle: Effect of Community Choir Singing in People With Chronic Post-stroke Aphasia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Ottawa, class: OTHER, collaborators name: Toronto Metropolitan University, collaborators name: Université de Montréal, collaborators name: Université du Québec à Trois-Rivières, collaborators name: University of South Florida, descriptionModule briefSummary: The goal of this randomized controled trial is to test the effects of assigning people with chronic post-stroke aphasia to 12 weekly choir sessions, compared to usual care.The main question it aims to answer is:Does the assignment to a choir singing program causes a beneficial effect on functional communication and language recovery as well as psychosocial outcomes compared to usual care in the rehabilitation of people with chronic post-stroke aphasia?Participants will have:12 in-person choir-singing sessions (1 session/week, 1,5 h/session, total 18h) conducted by a choir master, and home singing training (3 x 30-minutes-sessions/week, total 18h), conditionsModule conditions: Aphasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A parallel group randomized trial design with a secondary crossover extension, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcomes will be measured by blinded assessors where possible, using blinded video or audio recordings., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Choir singing, interventions name: Usual care, outcomesModule primaryOutcomes measure: Communication Index, secondaryOutcomes measure: Level of confidence in communication, secondaryOutcomes measure: Aphasia severity index, secondaryOutcomes measure: Speech and language in functional communication, secondaryOutcomes measure: Apraxia of speech severity, secondaryOutcomes measure: Health related quality of life assessed by the the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39), secondaryOutcomes measure: Emotional wellbeing, secondaryOutcomes measure: Social participation, secondaryOutcomes measure: Generic measure of health, secondaryOutcomes measure: Appetence to music, secondaryOutcomes measure: Singing voice abilities, otherOutcomes measure: Voice - Pitch, otherOutcomes measure: Voice - Maximum Phonation Time, otherOutcomes measure: Voice - Dynamic range, otherOutcomes measure: Mood, otherOutcomes measure: Biosocial indexes, otherOutcomes measure: Expectations on a 100-scale, otherOutcomes measure: Satisfaction on a 100-scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of South Florida, status: NOT_YET_RECRUITING, city: Tampa, state: Florida, zip: 33620, country: United States, contacts name: Jennifer Bugos, Ph.D., role: CONTACT, email: bugosj@usf.edu, geoPoint lat: 27.94752, lon: -82.45843, locations facility: University of Ottawa, status: RECRUITING, city: Ottawa, state: Ontario, zip: K1N 6N5, country: Canada, contacts name: Anna Zumbansen, PhD, role: CONTACT, phone: 613-562-5800, phoneExt: 8393, email: azumbans@uottawa.ca, contacts name: Narges Bayat, Master, role: CONTACT, phone: 613-562-5800, phoneExt: 8393, email: nbaya063@uottawa.ca, geoPoint lat: 45.41117, lon: -75.69812, locations facility: Toronto Metropolitan University, status: NOT_YET_RECRUITING, city: Toronto, state: Ontario, zip: M5B 0C3, country: Canada, contacts name: Arla Good, Ph.D., role: CONTACT, email: arla.good@torontomu.ca, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Université de Montréal, status: NOT_YET_RECRUITING, city: Montréal, state: Quebec, zip: H3C 3J7, country: Canada, contacts name: Carole Anglade, Ph.D., role: CONTACT, email: carole.anglade@umontreal.ca, geoPoint lat: 45.50884, lon: -73.58781, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-04-16, uploadDate: 2024-04-10T11:45, filename: ICF_000.pdf, size: 129388, hasResults: False