Skip to main content
OpenTrials
Completed

NCT Number: NCT03501797

Choir Singing in Aphasia Rehabilitation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Aphasia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital, Department of Neurology, Rehabilitation Unit, Helsinki, Finland

Loading trial locations.

About this study

BACKGROUND: Singing is a highly stimulating and versatile activity for the brain, combining vocal-motor, auditory, linguistic, cognitive, emotional, and social brain processes, both in the left and right hemisphere. The capacity to sing is often preserved in aphasia after stroke, and singing-based methods, such as Melodic Intonation Therapy (MIT), can be effective in rehabilitating speech production in aphasics. Also emotionally and socially, singing could provide a powerful alternative channel for aphasic patients to express their emotions and interact with others, but the communal or group-level use of singing in aphasia rehabilitation has not been systematically studied.

AIMS: The purpose of the study is to determine the clinical and neural efficacy of a novel choir singing intervention in subacute/chronic aphasia. Specifically, the targeted outcomes are (i) verbal and vocal-motor skills, (ii) cognitive skills, (iii) emotional functioning and quality of life, (iv) caregiver psychological well-being, and (v) structural and functional neuroplasticity. In addition, the capacity of singing and music learning in aphasia is explored.

METHODS: Subjects are 60 stroke patients with at least minor aphasia (≥ 6 months post-stroke) and their family members (FMs, N = 60) from Helsinki area recruited to a cross-over RCT study. Participants are randomized to two groups [N = 60 in both (30 patients, 30 FMs)], which receive a 16-week choir intervention either during the first (AB group) or second (BA group) half of the follow-up. The intervention is a combination of group training, which utilizes a novel combination of traditional senior choir singing and MIT-like speech training protocols, and home training in which the choir material is trained with a tablet computer. All patients are evaluated at baseline, 5-month, and 9-month stages with language, cognitive, and auditory-music tests and questionnaires. Half of the patients (N = 30) also undergo electroencephalography (EEG) and structural and functional magnetic resonance imaging (s/fMRI). FMs are evaluated with questionnaires.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

The following inclusion criteria are used in patient recruiment:

  • 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).

Treatment and study plan

Singing-based rehabilitation

Behavioral

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.

Standard care

Other

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

Primary outcomes

  1. Communication ability

    Time frame: Change from baseline at 5 months and 9 months

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

  2. Spontaneous speech production

    Time frame: Change from baseline at 5 months and 9 months

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

  3. Connected speech informativeness

    Time frame: Change from baseline at 5 months and 9 months

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

  4. Repetition of words and sentences

    Time frame: Change from baseline at 5 months and 9 months

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

  5. Verbal agility

    Time frame: Change from baseline at 5 months and 9 months

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

  6. Naming and word finding

    Time frame: Change from baseline at 5 months and 9 months

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

  7. Verbal comprehension

    Time frame: Change from baseline at 5 months and 9 months

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

Secondary outcomes

  1. Executive function (correct responses)

    Time frame: Change from baseline at 5 months and 9 months

    Simon Task: score (range 0-100, higher score indicates better outcome)

  2. Executive function (reaction times)

    Time frame: Change from baseline at 5 months and 9 months

    Simon Task: reaction time mean (ms)

  3. Attention (correct responses)

    Time frame: Change from baseline at 5 months and 9 months

    Flexible Attention Test (FAT): score (range 0-48, higher score indicates better outcome)

  4. Attention (reaction times)

    Time frame: Change from baseline at 5 months and 9 months

    Flexible Attention Test (FAT): reaction time mean (ms)

  5. Working memory

    Time frame: Change from baseline at 5 months and 9 months

    Word Span subtest score of the Kielelliset Arviointitehtävät (KAT) (range 0-30, higher score indicates better outcome)

  6. Verbal memory

    Time frame: Change from baseline at 5 months and 9 months

    Logical Memory subtest score of the Wechsler Memory Scale III (WMS-III) (range 0-80, higher score indicates better outcome)

  7. Verbal learning

    Time frame: Change from baseline at 5 months and 9 months

    Word Lists subtest score of the Wechsler Memory Scale III (WMS-III) (range 0-84, higher score indicates better outcome)

  8. Singing ability

    Time frame: Change from baseline at 5 months and 9 months

    Acoustic features (e.g., pitch, rhythm, intensity) analyzed from recorded production of familiar and novel songs using acoustic analysis software

  9. Music perception

    Time frame: Change from baseline at 5 months and 9 months

    Montreal Battery of Evaluation of Amusia (MBEA) score (range 0-30, higher score indicates better outcome)

  10. Functional stroke recovery

    Time frame: Change from baseline at 5 months and 9 months

    Total score of the Stroke Impact Scale (SIS) questionnaire (range 0-900, higher score indicates better outcome)

  11. Depression

    Time frame: Change from baseline at 5 months and 9 months

    Total score of the Center for Epidemiological Studies Depression Scale (CES-D) questionnaire (range 0-60, lower score indicates better outcome)

  12. Mood

    Time frame: Change from baseline at 5 months and 9 months

    Total score of the Visual Analog Mood Scales (VAMS) questionnaire (range 0-800, higher score indicates better outcome)

  13. Social interaction

    Time frame: Change from baseline at 5 months and 9 months

    Total score of the Social Provision Scale (SPS) questionnaire (range 24-96, higher score indicates better outcome)

  14. Caregiver burden

    Time frame: Change from baseline at 5 months and 9 months

    Total score of the Zarit Burden Interview (ZBI-22) questionnaire (range 0-88, lower score indicates better outcome)

  15. Psychological stress of the caregiver

    Time frame: Change from baseline at 5 months and 9 months

    Total score of the General Health Questionnaire (GHQ-12) (range 0-36, lower score indicates better outcome)

  16. Electroencephalography (EEG)

    Time frame: Change from baseline at 5 months and 9 months

    Amplitude and latency of event-related potentials (ERPs) associated with learning and memory in two auditory tasks

  17. Structural magnetic resonance imaging (sMRI): MPRAGE sequence

    Time frame: Change from baseline at 5 months and 9 months

    Grey matter volume in frontotemporal, frontoparietal, and limbic brain regions

  18. Structural magnetic resonance imaging (sMRI): DTI sequence

    Time frame: Change from baseline at 5 months and 9 months

    Structural connectivity of intra- and interhemispheric white matter tracts

  19. Functional magnetic resonance imaging (fMRI): resting-state

    Time frame: Change from baseline at 5 months and 9 months

    resting-state fMRI sequence: functional connectivity of frontotemporal, frontoparietal, and limbic brain networks

  20. Functional magnetic resonance imaging (fMRI): singing-related activity

    Time frame: Change from baseline at 5 months and 9 months

    task-based fMRI sequence: frontotemporal, frontoparietal, and limbic activation patterns associated with the perception, vocal repetition, and recall of novel songs

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • Finnish Brain Association
  • Harvard Medical School (HMS and HSDM)
  • Helsinki University Central Hospital
  • Helsinki-Uusimaa Aphasia and Stroke Association
  • Hospital District of Helsinki and Uusimaa
  • Outloud Ltd
  • University of Barcelona
  • University of Melbourne

Registry information

Official study title

Efficacy of Choir Singing on Verbal, Cognitive, Emotional, and Neural Recovery From Aphasia

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 18, 2018
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.