Choir Singing in Aphasia Rehabilitation
Primary Purpose
Stroke, Aphasia
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Singing-based rehabilitation
Standard care
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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).
Sites / Locations
- Helsinki University Central Hospital, Department of Neurology, Rehabilitation Unit
- Helsinki-Uusimaa Aphasia and Stroke Association
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Early singing intervention (AB)
Late singing intervention (BA)
Arm Description
Participants receive a 16 weeks of singing-based rehabilitation and standard care (SC) followed by 16 weeks of SC only.
Participants receive a 16 weeks of SC only followed by 16 weeks of singing intervention and SC.
Outcomes
Primary Outcome Measures
Communication ability
Total score of the Communication Action Log (CAL) questionnaire (range 0-180, higher score indicates better outcome)
Spontaneous speech production
Spontaneous Speech subscale score of the Western Aphasia Battery (WAB) (range 0-20, higher score indicates better outcome)
Connected speech informativeness
Percentage of correct information units (CIUs) produced in a picture description task
Repetition of words and sentences
Repetition subscale score of the Western Aphasia Battery (WAB) (range 0-100, higher score indicates better outcome)
Verbal agility
Verbal Agility subtest score of the Boston Diagnostic Aphasia Examinaton (BDAE) (range 0-14, higher score indicates better outcome)
Naming and word finding
Naming and Word Finding subscale score of the Western Aphasia Battery (WAB) (range 0-100, higher score indicates better outcome)
Verbal comprehension
Sequential Commands subtest score of the Western Aphasia Battery (WAB) (range 0-80, higher score indicates better outcome)
Secondary Outcome Measures
Executive function (correct responses)
Simon Task: score (range 0-100, higher score indicates better outcome)
Executive function (reaction times)
Simon Task: reaction time mean (ms)
Attention (correct responses)
Flexible Attention Test (FAT): score (range 0-48, higher score indicates better outcome)
Attention (reaction times)
Flexible Attention Test (FAT): reaction time mean (ms)
Working memory
Word Span subtest score of the Kielelliset Arviointitehtävät (KAT) (range 0-30, higher score indicates better outcome)
Verbal memory
Logical Memory subtest score of the Wechsler Memory Scale III (WMS-III) (range 0-80, higher score indicates better outcome)
Verbal learning
Word Lists subtest score of the Wechsler Memory Scale III (WMS-III) (range 0-84, higher score indicates better outcome)
Singing ability
Acoustic features (e.g., pitch, rhythm, intensity) analyzed from recorded production of familiar and novel songs using acoustic analysis software
Music perception
Montreal Battery of Evaluation of Amusia (MBEA) score (range 0-30, higher score indicates better outcome)
Functional stroke recovery
Total score of the Stroke Impact Scale (SIS) questionnaire (range 0-900, higher score indicates better outcome)
Depression
Total score of the Center for Epidemiological Studies Depression Scale (CES-D) questionnaire (range 0-60, lower score indicates better outcome)
Mood
Total score of the Visual Analog Mood Scales (VAMS) questionnaire (range 0-800, higher score indicates better outcome)
Social interaction
Total score of the Social Provision Scale (SPS) questionnaire (range 24-96, higher score indicates better outcome)
Caregiver burden
Total score of the Zarit Burden Interview (ZBI-22) questionnaire (range 0-88, lower score indicates better outcome)
Psychological stress of the caregiver
Total score of the General Health Questionnaire (GHQ-12) (range 0-36, lower score indicates better outcome)
Electroencephalography (EEG)
Amplitude and latency of event-related potentials (ERPs) associated with learning and memory in two auditory tasks
Structural magnetic resonance imaging (sMRI): MPRAGE sequence
Grey matter volume in frontotemporal, frontoparietal, and limbic brain regions
Structural magnetic resonance imaging (sMRI): DTI sequence
Structural connectivity of intra- and interhemispheric white matter tracts
Functional magnetic resonance imaging (fMRI): resting-state
resting-state fMRI sequence: functional connectivity of frontotemporal, frontoparietal, and limbic brain networks
Functional magnetic resonance imaging (fMRI): singing-related activity
task-based fMRI sequence: frontotemporal, frontoparietal, and limbic activation patterns associated with the perception, vocal repetition, and recall of novel songs
Full Information
NCT ID
NCT03501797
First Posted
February 16, 2018
Last Updated
August 17, 2022
Sponsor
University of Helsinki
Collaborators
Helsinki University Central Hospital, Hospital District of Helsinki and Uusimaa, Helsinki-Uusimaa Aphasia and Stroke Association, Finnish Brain Association, Outloud Ltd, University of Barcelona, University of Melbourne, Harvard Medical School (HMS and HSDM)
1. Study Identification
Unique Protocol Identification Number
NCT03501797
Brief Title
Choir Singing in Aphasia Rehabilitation
Official Title
Efficacy of Choir Singing on Verbal, Cognitive, Emotional, and Neural Recovery From Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki
Collaborators
Helsinki University Central Hospital, Hospital District of Helsinki and Uusimaa, Helsinki-Uusimaa Aphasia and Stroke Association, Finnish Brain Association, Outloud Ltd, University of Barcelona, University of Melbourne, Harvard Medical School (HMS and HSDM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early singing intervention (AB)
Arm Type
Experimental
Arm Description
Participants receive a 16 weeks of singing-based rehabilitation and standard care (SC) followed by 16 weeks of SC only.
Arm Title
Late singing intervention (BA)
Arm Type
Experimental
Arm Description
Participants receive a 16 weeks of SC only followed by 16 weeks of singing intervention and SC.
Intervention Type
Behavioral
Intervention Name(s)
Singing-based rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
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 Outcome Measure Information:
Title
Communication ability
Description
Total score of the Communication Action Log (CAL) questionnaire (range 0-180, higher score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Spontaneous speech production
Description
Spontaneous Speech subscale score of the Western Aphasia Battery (WAB) (range 0-20, higher score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Connected speech informativeness
Description
Percentage of correct information units (CIUs) produced in a picture description task
Time Frame
Change from baseline at 5 months and 9 months
Title
Repetition of words and sentences
Description
Repetition subscale score of the Western Aphasia Battery (WAB) (range 0-100, higher score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Verbal agility
Description
Verbal Agility subtest score of the Boston Diagnostic Aphasia Examinaton (BDAE) (range 0-14, higher score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Naming and word finding
Description
Naming and Word Finding subscale score of the Western Aphasia Battery (WAB) (range 0-100, higher score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Verbal comprehension
Description
Sequential Commands subtest score of the Western Aphasia Battery (WAB) (range 0-80, higher score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Secondary Outcome Measure Information:
Title
Executive function (correct responses)
Description
Simon Task: score (range 0-100, higher score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Executive function (reaction times)
Description
Simon Task: reaction time mean (ms)
Time Frame
Change from baseline at 5 months and 9 months
Title
Attention (correct responses)
Description
Flexible Attention Test (FAT): score (range 0-48, higher score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Attention (reaction times)
Description
Flexible Attention Test (FAT): reaction time mean (ms)
Time Frame
Change from baseline at 5 months and 9 months
Title
Working memory
Description
Word Span subtest score of the Kielelliset Arviointitehtävät (KAT) (range 0-30, higher score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Verbal memory
Description
Logical Memory subtest score of the Wechsler Memory Scale III (WMS-III) (range 0-80, higher score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Verbal learning
Description
Word Lists subtest score of the Wechsler Memory Scale III (WMS-III) (range 0-84, higher score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Singing ability
Description
Acoustic features (e.g., pitch, rhythm, intensity) analyzed from recorded production of familiar and novel songs using acoustic analysis software
Time Frame
Change from baseline at 5 months and 9 months
Title
Music perception
Description
Montreal Battery of Evaluation of Amusia (MBEA) score (range 0-30, higher score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Functional stroke recovery
Description
Total score of the Stroke Impact Scale (SIS) questionnaire (range 0-900, higher score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Depression
Description
Total score of the Center for Epidemiological Studies Depression Scale (CES-D) questionnaire (range 0-60, lower score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Mood
Description
Total score of the Visual Analog Mood Scales (VAMS) questionnaire (range 0-800, higher score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Social interaction
Description
Total score of the Social Provision Scale (SPS) questionnaire (range 24-96, higher score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Caregiver burden
Description
Total score of the Zarit Burden Interview (ZBI-22) questionnaire (range 0-88, lower score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Psychological stress of the caregiver
Description
Total score of the General Health Questionnaire (GHQ-12) (range 0-36, lower score indicates better outcome)
Time Frame
Change from baseline at 5 months and 9 months
Title
Electroencephalography (EEG)
Description
Amplitude and latency of event-related potentials (ERPs) associated with learning and memory in two auditory tasks
Time Frame
Change from baseline at 5 months and 9 months
Title
Structural magnetic resonance imaging (sMRI): MPRAGE sequence
Description
Grey matter volume in frontotemporal, frontoparietal, and limbic brain regions
Time Frame
Change from baseline at 5 months and 9 months
Title
Structural magnetic resonance imaging (sMRI): DTI sequence
Description
Structural connectivity of intra- and interhemispheric white matter tracts
Time Frame
Change from baseline at 5 months and 9 months
Title
Functional magnetic resonance imaging (fMRI): resting-state
Description
resting-state fMRI sequence: functional connectivity of frontotemporal, frontoparietal, and limbic brain networks
Time Frame
Change from baseline at 5 months and 9 months
Title
Functional magnetic resonance imaging (fMRI): singing-related activity
Description
task-based fMRI sequence: frontotemporal, frontoparietal, and limbic activation patterns associated with the perception, vocal repetition, and recall of novel songs
Time Frame
Change from baseline at 5 months and 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teppo Särkämö, PhD
Organizational Affiliation
University of Helsinki
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital, Department of Neurology, Rehabilitation Unit
City
Helsinki
Country
Finland
Facility Name
Helsinki-Uusimaa Aphasia and Stroke Association
City
Helsinki
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Choir Singing in Aphasia Rehabilitation
We'll reach out to this number within 24 hrs