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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368323
• Other study ID #: H-01-24-9931
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: University of Ottawa
• Contact: Anna Zumbansen, PhD
• Phone: 613-562-5800
• Email: azumbans[@]uottawa.ca
• Is FDA regulated: No
• Study type: Interventional

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)

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia

Intervention

Behavioral:
• 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).

Other:
• Usual care
Rehabilitation services received by patients and social activities will be monitored and documented.

Locations

Country	Name	City	State
Canada	Université de Montréal	Montréal	Quebec
Canada	University of Ottawa	Ottawa	Ontario
Canada	Toronto Metropolitan University	Toronto	Ontario
United States	University of South Florida	Tampa	Florida

Sponsors (5)

Lead Sponsor	Collaborator
University of Ottawa	Toronto Metropolitan University, Université de Montréal, Université du Québec à Trois-Rivières, University of South Florida

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Voice - Pitch	Pitch mean, standard deviation, and range in spontaneous speech based on a quick standardized voice production protocol	Before and afrer choir sessions 2, 6, 10 and 12
Other	Voice - Maximum Phonation Time	Maximum Phonation Time based on a quick standardized voice production protocol	Before and afrer choir sessions 2, 6, 10 and 12
Other	Voice - Dynamic range	Dynamic range based on a quick standardized voice production protocol	Before and afrer choir sessions 2, 6, 10 and 12
Other	Mood	Temporary state of mind or temper / assessed with the Observed Emotion Rating Scale (OERS), an observational tool for rating two positive emotions (pleasure and general alertness) and three negative emotions (anger, anxiety or fear, and sadness) over a defined 10-minute period. A longer display of emotion is indicated by higher scores.	The first and last 10 minutes of sessions 2, 6, 10 and 12 as well as the last 10 minutes of the break.
Other	Biosocial indexes	Cortisol and oxytocin measures / measured in salivary samples	Before and afrer choir sessions 2, 6, 10 and 12
Other	Expectations on a 100-scale	Measures expectations based on a feedback questionnaire. Minimum value=0; Maximum value=100; Higher scores mean a better outcome.	T1 (baseline, week 1),T5 (week 31)
Other	Satisfaction on a 100-scale	Measures satisfaction based on a feedback questionnaire. Minimum value=0; Maximum value=100; Higher scores mean a better outcome.	T1 (baseline, week 1),T5 (week 31)
Primary	Communication Index	The ability to communicate one's feelings and basic needs effectively / is computed by averaging the percentage scores (score/total×100) of the Communicative Activity Log (CAL) and the communication subscale of the Stroke Impact Scale 3.0 (SIS).; Minimum value=0; Maximum value=100; Higher scores mean a better outcome.	T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Secondary	Level of confidence in communication	Individual's subjective perception of their ability to effectively communicate in various situations / assessed with the Communication Confidence Rating Scale for Aphasia (CCRSA), a self-reported assessment in 10 questions.; Minimum value=4; Maximum value=40; Higher scores mean a better outcome.	T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Secondary	Aphasia severity index	The aphasia severity index quantifies the extent of language impairment experienced by individuals with aphasia / assessed using the Quick Aphasia Battery (QAB).; Minimum value=0; Maximum value=10; Higher scores mean a better outcome.	T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Secondary	Speech and language in functional communication	The ability of an individual to effectively use verbal communication skills / assessed with a part of the AphasiaBank protocol to elicit connected speech in participants Minimum value=0; Maximum value=100; Higher scores mean a better outcome.	T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Secondary	Apraxia of speech severity	The degree or level of impairment in the motor planning and execution of speech movements / assessed with the Apraxia of Speech Rating Scale (ASRS-3.5) experienced by individuals with apraxia Minimum value=0; Maximum value=52; Higher scores mean a worse outcome.	T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Secondary	Health related quality of life assessed by the the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)	Individual's subjective perception of their physical, emotional, mental, and social well-being in relation to their health status and the impact of illness or treatment on their overall quality of life / assessed with the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Minimum value=39; Maximum value=195; Higher scores mean a better outcome.	T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Secondary	Emotional wellbeing	The state of an individual's mental and emotional health, encompassing their overall mood, psychological resilience, and ability to cope with stressors and life challenges / assessed using the General Health Questionnaire (GHQ-12) Minimum value=0; Maximum value=36; Higher scores mean a worse outcome.	T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Secondary	Social participation	Active engagement of individuals within their community or society, involving various social activities, interactions, and roles. / assessed using the corresponding SIS participation subscale.; Minimum value=8; Maximum value=40; Higher scores mean a better outcome.	T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Secondary	Generic measure of health	Short-Form 6-Dimension version 2 (SF-6Dv2) is a survey on 6 health domains: Physical functioning, Role functioning, Pain, Vitality, Social functioning, Mental health.; Minimum value= 0; Maximum value= 100;Higher scores mean a better outcome.	T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Secondary	Appetence to music	An individual's inclination or attraction towards music / Barcelona Music Reward Questionnaire (BMRQ); Minimum value= 20; Maximum value= 100 ; Higher scores mean a better outcome.	T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Secondary	Singing voice abilities	Overall singing voice quality, tuning and rhythmic accuracy / assessed following a standardized protocol	T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)

External Links

•   The SingWell Project