Clinical trial NCT06368323: Effect of Community Choir Singing in People With Chronic Post-stroke Aphasia
Official title: Effect of Community Choir Singing in People With Chronic Post-stroke Aphasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aphasia
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: Toronto Metropolitan University
name: Université de Montréal
name: Université du Québec à Trois-Rivières
name: University of South Florida
First posted: 2024-04-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel group randomized trial design with a secondary crossover extension
Primary purpose: TREATMENT

Brief summary: 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)

Detailed description: Description of study population Additional information: Participants with chronic aphasia due to stroke will be recruited from four participating centers in Canada and the United States.

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).

Eligibility criteria: Inclusion Criteria:

* People with chronic aphasia following stroke
* 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:

* Regular music making in the past 6 months
* 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

Primary outcomes:
measure: Communication Index
timeFrame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Secondary outcomes:
measure: Level of confidence in communication
timeFrame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
measure: Aphasia severity index
timeFrame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
measure: Speech and language in functional communication
timeFrame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
measure: Apraxia of speech severity
timeFrame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
measure: Health related quality of life assessed by the the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
timeFrame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
measure: Emotional wellbeing
timeFrame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
measure: Social participation
timeFrame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
measure: Generic measure of health
timeFrame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
measure: Appetence to music
timeFrame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
measure: Singing voice abilities
timeFrame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Other outcomes:
measure: Voice - Pitch
timeFrame: Before and afrer choir sessions 2, 6, 10 and 12
measure: Voice - Maximum Phonation Time
timeFrame: Before and afrer choir sessions 2, 6, 10 and 12
measure: Voice - Dynamic range
timeFrame: Before and afrer choir sessions 2, 6, 10 and 12
measure: Mood
timeFrame: The first and last 10 minutes of sessions 2, 6, 10 and 12 as well as the last 10 minutes of the break.
measure: Biosocial indexes
timeFrame: Before and afrer choir sessions 2, 6, 10 and 12
measure: Expectations on a 100-scale
timeFrame: T1 (baseline, week 1),T5 (week 31)
measure: Satisfaction on a 100-scale
timeFrame: T1 (baseline, week 1),T5 (week 31)
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
city: Toronto
country: Canada
facility: Toronto Metropolitan University
state: Ontario
city: Montréal
country: Canada
facility: Université de Montréal
state: Quebec
Study officials:
affiliation: University of Ottawa
name: Anna Zumbansen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto Metropolitan University
name: Arla Good, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto Metropolitan University
name: Frank Russo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Carole Anglade, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université du Québec à Trois-Rivières
name: Édith Durand, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: Jennifer Bugos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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