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临床试验/NCT06368323
NCT06368323招募中不适用

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

University of Ottawa4 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2024年4月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
4
主要终点
Communication Index

研究概览

简要总结

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)

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes will be measured by blinded assessors where possible, using blinded video or audio recordings.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

AB Group

Experimental

First choir, then usual care

干预措施: Choir singing (Behavioral)

AB Group

Experimental

First choir, then usual care

干预措施: Usual care (Other)

BA Group

Experimental

First usual care, then choir

干预措施: Choir singing (Behavioral)

BA Group

Experimental

First usual care, then choir

干预措施: Usual care (Other)

结局指标

主要结局

Communication Index

时间窗: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)

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.

次要结局

  • Generic measure of health(T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31))
  • Apraxia of speech severity(T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31))
  • Health related quality of life assessed by the the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)(T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31))
  • Emotional wellbeing(T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31))
  • Social participation(T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31))
  • Singing voice abilities(T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31))
  • Level of confidence in communication(T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31))
  • Aphasia severity index(T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31))
  • Speech and language in functional communication(T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31))
  • Appetence to music(T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Zumbansen

Professor

University of Ottawa

研究点 (4)

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