Effect of Community Choir Singing in People With Chronic Post-stroke Aphasia
NCT ID: NCT06368323
Last Updated: 2024-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-04-22
2025-12-31
Brief Summary
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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)
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Detailed Description
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Study design Additional information: A parallel group randomized trial design with a secondary crossover extension was chosen for this study to offer the intervention to all participants. Participants will be randomized in a 1:1 ratio to two study arms (AB/BA, A = 12 weekly choir sessions and home singing training, B = usual care) stratified for aphasia severity (according to the Quick Aphasia Battery overall score), age, time since last stroke and their interest in music (according to the Barcelona Music Reward Questionnaire). Measures at the "macro" level will be collected at Baseline, Completion and 2-months Follow-up time points for each group. At the "micro" level (i.e., at choir sessions 2, 6, 10 and 12) data will be collected during as well as pre and post choir-singing.
Intervention Additional information: The repertoire in the comunity choir activity will consist of popular songs in English or French. Half of the songs will be pre-determined and half will be chosen by the choir members from a list, based on a vote during the first week of the intervention. Eligible songs will remain within the range of an octave and include a variety of tempi (but fast tempi will be slowed down if needed to facilitate word production). Depending on the group's abilities, the Choir Director will decide in which keys the songs will be performed, and whether they will be sung in unison or with simple harmonies. Songs in canon will be included in the predetermined repertoire to easily create harmonies. Each session will include (in this order): 15 minutes for vocal warm-up; 25 minutes of work on the song repertoire; 20 minutes for a social break with refreshments.
For the home training, participants will be instructed to sing at home with a video guide on an online platform. Each home training session will include (in this order): 10 minutes for vocal warm-up; and 20 minutes sing-along using songs of the repertoire. Song lyrics will be displayed on the video.
To monitor the usual care, each participant (and/or caregiver) will complete a form and/or have a weekly 5-15-minute phone/Zoom call with a research assistant to collect the usual care data including type and time spent in social activities and rehabilitation services, as well as adverse events.
Randomization and concealment For randomization, an online system will be used by a researcher not involved in data collection.
Each participant will be assigned an identification number upon inclusion in the study. After completion of the baseline assessments, the independent researcher will receive the list of participants' IDs with their stratification data (age, time post-stoke, aphasia severity, level of interest in music) to perform the randomization.
Blinding:
Outcomes will be measured by blinded assessors where possible, based on video or audio recordings.
Planned analyses:
Primary hypothesis:
Participants assigned to the choir intervention over 12 weeks will demonstrate a significantly larger improvement in macro-level measures compared to those receiving usual care.
Secondary hypothesis:
Participants who completed the choir intervention with 80% adherence over 12 weeks will demonstrate a larger improvement in macro-level measures compared to those receiving usual care.
The gains will be maintained for the participants with 80% adherence.
There will be immediate changes in micro-level measures after a choir session (Session 6).
There will be differences in pre-post-session variations of micro-level measures between Session 2, 6 and 10.
There will be differences in pre-post-session variations between the usual rehearsal (Session 10) and the Concert (Session 12).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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AB Group
First choir, then usual care
Choir singing
The 12-week intervention will consist of 12 in-person choir-singing sessions (1 session/week, 1,5 h/session, total 18h) conducted by a choir master in addition to home training (3 x 30-minutes-sessions/week, total 18h). In total, participants will undergo the intervention for 3 hours/week for 12 weeks (i.e., 36 hours).
Usual care
Rehabilitation services received by patients and social activities will be monitored and documented.
BA Group
First usual care, then choir
Choir singing
The 12-week intervention will consist of 12 in-person choir-singing sessions (1 session/week, 1,5 h/session, total 18h) conducted by a choir master in addition to home training (3 x 30-minutes-sessions/week, total 18h). In total, participants will undergo the intervention for 3 hours/week for 12 weeks (i.e., 36 hours).
Usual care
Rehabilitation services received by patients and social activities will be monitored and documented.
Interventions
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Choir singing
The 12-week intervention will consist of 12 in-person choir-singing sessions (1 session/week, 1,5 h/session, total 18h) conducted by a choir master in addition to home training (3 x 30-minutes-sessions/week, total 18h). In total, participants will undergo the intervention for 3 hours/week for 12 weeks (i.e., 36 hours).
Usual care
Rehabilitation services received by patients and social activities will be monitored and documented.
Eligibility Criteria
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Inclusion Criteria
* English or French as language of daily use
* Last stroke must have occurred at least 6 months before the start of the first assessments in the study protocol.
Exclusion Criteria
* Visual deficit that cannot be corrected and might impair testing
* Hearing deficit that cannot be corrected and might impair testing
* Presence of neurological/psychiatric co-morbidity or substance abuse
* No ability to produce vocal sound through singing/humming
* Legally considered unable to make decisions for oneself
18 Years
ALL
No
Sponsors
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Toronto Metropolitan University
OTHER
Université de Montréal
OTHER
Université du Québec à Trois-Rivières
OTHER
University of South Florida
OTHER
University of Ottawa
OTHER
Responsible Party
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Anna Zumbansen
Professor
Principal Investigators
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Anna Zumbansen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Ottawa
Arla Good, PhD
Role: PRINCIPAL_INVESTIGATOR
Toronto Metropolitan University
Frank Russo, PhD
Role: PRINCIPAL_INVESTIGATOR
Toronto Metropolitan University
Carole Anglade, PhD
Role: PRINCIPAL_INVESTIGATOR
Université de Montréal
Édith Durand, PhD
Role: PRINCIPAL_INVESTIGATOR
Université du Québec à Trois-Rivières
Jennifer Bugos, PhD
Role: PRINCIPAL_INVESTIGATOR
University of South Florida
Locations
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University of South Florida
Tampa, Florida, United States
University of Ottawa
Ottawa, Ontario, Canada
Toronto Metropolitan University
Toronto, Ontario, Canada
Université de Montréal
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Siponkoski ST, Pitkaniemi A, Laitinen S, Sarkamo ER, Pentikainen E, Eloranta H, Tuomiranta L, Melkas S, Schlaug G, Sihvonen AJ, Sarkamo T. Efficacy of a multicomponent singing intervention on communication and psychosocial functioning in chronic aphasia: a randomized controlled crossover trial. Brain Commun. 2022 Dec 27;5(1):fcac337. doi: 10.1093/braincomms/fcac337. eCollection 2023.
Anna Zumbansen, Isabelle Peretz, Carole Anglade, Josée Bilodeau, Suzanne Généreux, Michelyne Hubert & Sylvie Hébert (2017) Effect of choir activity in the rehabilitation of aphasia: a blind, randomised, controlled pilot study, Aphasiology, 31:8, 879-900, DOI: 10.1080/02687038.2016.1227424
Provided Documents
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Document Type: Informed Consent Form
Related Links
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The SingWell Project
Other Identifiers
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H-01-24-9931
Identifier Type: -
Identifier Source: org_study_id
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