Effect of Community Choir Singing in People With Chronic Post-stroke Aphasia

Aphasia Clinical Trial

Official title: Effect of Community Choir Singing in People With Chronic Post-stroke Aphasia

Status Recruiting

Clinical Trial 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)

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Aphasia

• NCT number: NCT06368323
• Study type: Interventional
• Source: University of Ottawa
• Contact: Anna Zumbansen, PhD
• Phone: 613-562-5800
• Email: azumbans@uottawa.ca
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2024
• Completion date: December 31, 2025