Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368323
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-01
Brief Title:
Effect of Community Choir Singing in People With Chronic Post-stroke Aphasia
Sponsor:
University of Ottawa
Organization:
University of Ottawa
Study Overview
Official Title:
Effect of Community Choir Singing in People With Chronic Post-stroke Aphasia
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 sessionweek 15 hsession total 18h conducted by a choir master and home singing training 3 x 30-minutes-sessionsweek total 18h
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 sessionweek 15 hsession total 18h conducted by a choir master and home singing training 3 x 30-minutes-sessionsweek 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 11 ratio to two study arms ABBA 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 ie 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 groups 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 andor caregiver will complete a form andor have a weekly 5-15-minute phoneZoom 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
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 11 ratio to two study arms ABBA 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 ie 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 groups 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 andor caregiver will complete a form andor have a weekly 5-15-minute phoneZoom 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None