NCT06368323

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)

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Apr 2024Sep 2027

First Submitted

Initial submission to the registry

April 1, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

April 22, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3.4 years

First QC Date

April 1, 2024

Last Update Submit

February 12, 2026

Conditions

Aphasia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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)

  • 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)

  • +5 more secondary outcomes

Other Outcomes (7)

  • Voice - Pitch

    Before and afrer choir sessions 2, 6, 10 and 12

  • Voice - Maximum Phonation Time

    Before and afrer choir sessions 2, 6, 10 and 12

  • Voice - Dynamic range

    Before and afrer choir sessions 2, 6, 10 and 12

  • +4 more other outcomes

Study Arms (2)

AB Group

EXPERIMENTAL

First choir, then usual care

Behavioral: Choir singingOther: Usual care

BA Group

EXPERIMENTAL

First usual care, then choir

Behavioral: Choir singingOther: Usual care

Interventions

Choir singingBEHAVIORAL

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).

AB GroupBA Group
Usual careOTHER

Rehabilitation services received by patients and social activities will be monitored and documented.

AB GroupBA Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of South Florida

Tampa, Florida, 33620, United States

NOT YET RECRUITING

University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

COMPLETED

Toronto Metropolitan University

Toronto, Ontario, M5B 0C3, Canada

RECRUITING

Université de Montréal

Montreal, Quebec, H3C 3J7, Canada

COMPLETED

Related Publications (2)

  • 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.

    PMID: 36687394BACKGROUND

  • 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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anna Zumbansen, PhD

    University of Ottawa

    PRINCIPAL INVESTIGATOR

  • Arla Good, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

  • Frank Russo, PhD

    Toronto Metropolitan University

    PRINCIPAL INVESTIGATOR

  • Carole Anglade, PhD

    Université de Montréal

    PRINCIPAL INVESTIGATOR

  • Édith Durand, PhD

    Université du Québec à Trois-Rivières

    PRINCIPAL INVESTIGATOR

  • Jennifer Bugos, PhD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Zumbansen, PhD

CONTACT

613-562-5800azumbans@uottawa.ca

Narges Bayat, Master

CONTACT

613-562-5800nbaya063@uottawa.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes will be measured by blinded assessors where possible, using blinded video or audio recordings.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A parallel group randomized trial design with a secondary crossover extension
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 1, 2024

First Posted

April 16, 2024

Study Start

April 22, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)US(1)