NCT03501797

Brief Summary

This study evaluates the verbal, cognitive, emotional, and neural efficacy of a choir singing intervention in chronic aphasic patients and their caregivers. Using a cross-over RCT design, half of the participants receive a 4-month singing intervention during the first half of the study and half of the participants during the second half of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

January 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

2.1 years

First QC Date

February 16, 2018

Last Update Submit

August 17, 2022

Conditions

Outcome Measures

Primary Outcomes (7)

  • Communication ability

    Total score of the Communication Action Log (CAL) questionnaire (range 0-180, higher score indicates better outcome)

    Change from baseline at 5 months and 9 months

  • Spontaneous speech production

    Spontaneous Speech subscale score of the Western Aphasia Battery (WAB) (range 0-20, higher score indicates better outcome)

    Change from baseline at 5 months and 9 months

  • Connected speech informativeness

    Percentage of correct information units (CIUs) produced in a picture description task

    Change from baseline at 5 months and 9 months

  • Repetition of words and sentences

    Repetition subscale score of the Western Aphasia Battery (WAB) (range 0-100, higher score indicates better outcome)

    Change from baseline at 5 months and 9 months

  • Verbal agility

    Verbal Agility subtest score of the Boston Diagnostic Aphasia Examinaton (BDAE) (range 0-14, higher score indicates better outcome)

    Change from baseline at 5 months and 9 months

  • Naming and word finding

    Naming and Word Finding subscale score of the Western Aphasia Battery (WAB) (range 0-100, higher score indicates better outcome)

    Change from baseline at 5 months and 9 months

  • Verbal comprehension

    Sequential Commands subtest score of the Western Aphasia Battery (WAB) (range 0-80, higher score indicates better outcome)

    Change from baseline at 5 months and 9 months

Secondary Outcomes (20)

  • Executive function (correct responses)

    Change from baseline at 5 months and 9 months

  • Executive function (reaction times)

    Change from baseline at 5 months and 9 months

  • Attention (correct responses)

    Change from baseline at 5 months and 9 months

  • Attention (reaction times)

    Change from baseline at 5 months and 9 months

  • Working memory

    Change from baseline at 5 months and 9 months

  • +15 more secondary outcomes

Study Arms (2)

Early singing intervention (AB)

EXPERIMENTAL

Participants receive a 16 weeks of singing-based rehabilitation and standard care (SC) followed by 16 weeks of SC only.

Behavioral: Singing-based rehabilitationOther: Standard care

Late singing intervention (BA)

EXPERIMENTAL

Participants receive a 16 weeks of SC only followed by 16 weeks of singing intervention and SC.

Behavioral: Singing-based rehabilitationOther: Standard care

Interventions

The singing-based rehabilitation is a combination of group-training (16 weeks, 1 x week, 90 min), which utilizes a novel combination of traditional senior choir singing and singing-based speech training protocols, and home training (16 weeks, ≥ 3 x week, ≥ 30 min) in which the choir material is trained with a tablet computer.

Early singing intervention (AB)Late singing intervention (BA)

Standard care comprises all rehabilitation and care services (e.g. speech therapy, physical and occupational therapy, neuropsychological rehabilitation) received by the patients in the Finnish health care system

Early singing intervention (AB)Late singing intervention (BA)

Eligibility Criteria

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

You may qualify if:

  • age over 18
  • Finnish-speaking
  • time since stroke \> 6 months
  • at least minor non-fluent aphasia due to stroke (BDAE Aphasia Severity Rating scale score ≤ 4)
  • no hearing deficit
  • no severe cognitive impairment affecting comprehension (the patient is able to understand the purpose of the study and give an informed consent)
  • no neurological / psychiatric co-morbidity or substance abuse
  • ability to produce vocal sound (through singing or humming).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Helsinki University Central Hospital, Department of Neurology, Rehabilitation Unit

Helsinki, Finland

Location

Helsinki-Uusimaa Aphasia and Stroke Association

Helsinki, Finland

Location

Related Publications (2)

  • Martinez-Molina N, Pitkaniemi A, Siponkoski ST, Moisseinen N, Kuusela L, Laitinen S, Sarkamo ER, Pekkola J, Melkas S, Schlaug G, Kleber B, Sihvonen AJ, Sarkamo T. Functional neuroplasticity in chronic post-stroke aphasia following a singing intervention in a cross-over randomised trial. Sci Rep. 2025 Jul 29;15(1):27639. doi: 10.1038/s41598-025-11288-0.

  • 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.

MeSH Terms

Conditions

StrokeAphasia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Teppo Särkämö, PhD

    University of Helsinki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academy of Finland Research Fellow

Study Record Dates

First Submitted

February 16, 2018

First Posted

April 18, 2018

Study Start

January 1, 2018

Primary Completion

January 31, 2020

Study Completion

March 15, 2020

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations