Choir Singing in Aphasia Rehabilitation

August 17, 2022 updated by: Teppo Sarkamo, University of Helsinki

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Helsinki, Finland
        • Helsinki University Central Hospital, Department of Neurology, Rehabilitation Unit
      • Helsinki, Finland
        • Helsinki-Uusimaa Aphasia and Stroke Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

The following inclusion criteria are used in patient recruiment:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Early singing intervention (AB)
Participants receive a 16 weeks of singing-based rehabilitation and standard care (SC) followed by 16 weeks of SC only.
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 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
EXPERIMENTAL: Late singing intervention (BA)
Participants receive a 16 weeks of SC only followed by 16 weeks of singing intervention and SC.
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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline at 5 months and 9 months
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)
Change from baseline at 5 months and 9 months
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
Change from baseline at 5 months and 9 months
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)
Change from baseline at 5 months and 9 months
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)
Change from baseline at 5 months and 9 months
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)
Change from baseline at 5 months and 9 months
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)
Change from baseline at 5 months and 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline at 5 months and 9 months
Executive function (reaction times)
Time Frame: Change from baseline at 5 months and 9 months
Simon Task: reaction time mean (ms)
Change from baseline at 5 months and 9 months
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)
Change from baseline at 5 months and 9 months
Attention (reaction times)
Time Frame: Change from baseline at 5 months and 9 months
Flexible Attention Test (FAT): reaction time mean (ms)
Change from baseline at 5 months and 9 months
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)
Change from baseline at 5 months and 9 months
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)
Change from baseline at 5 months and 9 months
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)
Change from baseline at 5 months and 9 months
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
Change from baseline at 5 months and 9 months
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)
Change from baseline at 5 months and 9 months
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)
Change from baseline at 5 months and 9 months
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)
Change from baseline at 5 months and 9 months
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)
Change from baseline at 5 months and 9 months
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)
Change from baseline at 5 months and 9 months
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)
Change from baseline at 5 months and 9 months
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)
Change from baseline at 5 months and 9 months
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
Change from baseline at 5 months and 9 months
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
Change from baseline at 5 months and 9 months
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
Change from baseline at 5 months and 9 months
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
Change from baseline at 5 months and 9 months
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
Change from baseline at 5 months and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

January 31, 2020

Study Completion (ACTUAL)

March 15, 2020

Study Registration Dates

First Submitted

February 16, 2018

First Submitted That Met QC Criteria

April 10, 2018

First Posted (ACTUAL)

April 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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