Back to resultsEffect of Music on Reading Comprehension in Patients With Aphasia
Primary Purpose
Aphasia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simultaneous music and reading lyrics
Priming with music
Control
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring left middle cerebral artery, cerebrovascular accident (CVA), stroke
Eligibility Criteria
Inclusion Criteria:
Post-hospitalization;
- premorbid reading at the 8th grade level or higher based on the participant's/family's stated years of formal education;
- post-stroke aphasia/left middle cerebral artery (MCA) cerebral vascular accident (CVA) based on electronic medical record (EMR) and computed tomography (CT) and/or magnetic resonance imaging (MRI) imaging reports, or consult with the neurologist;
- intact left amygdala and left extrastriate cortex based on EMR and CT/MRI imaging reports, or consult with the neurologist;
- reliability in answering yes-no questions as determined by an 80% score on therapy tasks during regular speech therapy;
- capacity to provide informed consent concerning a study involving an intervention with music therapy determined by the physician who refers the patient.
Exclusion Criteria:
- Co-morbidities diagnosed and reported in the EMR or shown on CT scan or MRI including past history of stroke in other brain regions with residual symptoms, dementia, Parkinson disease, head injury, etc.;
- hemianopsia or other visual field defects affecting vision for reading, and in particular right homonymous hemi- or inferior quadrantanopsia;
- previous history of learning disabilities in reading/writing;
- significant psychiatric diagnosis;
- English as a Second Language or non-English language.
Sites / Locations
- Carilion Franklin Memorial Hospital, Carilion Community Memorial Hospital Inpatient Rehab, Carilion Day Rehab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Music and reading lyrics
Arm Description
A single-subject adapted alternating treatment design will be used to compare two music conditions, using music with sung lyrics simultaneously with silent reading of the lyrics, and priming with music and sung lyrics followed by reading of the lyrics, with a control condition using reading materials without music.
Outcomes
Primary Outcome Measures
Percent correct responses per day on phrase completion task.
Differential response to the interventions (counted as the percent correct responses per day).
Number of sessions required to achieve mastery.
Count number of sessions.
Retention of the reading material.
Number of items recalled.
Secondary Outcome Measures
International Classification of Functioning, Disability, and Health (ICF) body Functions/Structures, Activities, and Participation.
Pretest-posttest information on the ICF Body Functions/Structures, Activities, and Participation (Hurkmans et al., 2011).
Boston Diagnostic Aphasia Examination-Third Edition (BDAE-3) (Goodglass, Harold, & Barresi, Austin: PRO-Ed.).
BDAE-3 pretest-posttest reading scores on subtests: Word Identification/Word-Picture Match and Lexical Decision; Homophone Matching; Derivational and Grammatical Morphology/Matching to spoken sample; Oral Reading/Basic oral word reading; Oral Reading of Sentences with Comprehension; and Reading Comprehension-Sentences and Paragraphs. Pretest will be completed prior to baseline and initiating intervention, and posttest with be completed immediately following completion of intervention to assess generalization to non-trained stimuli.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03600987
Brief Title
Effect of Music on Reading Comprehension in Patients With Aphasia
Official Title
Effect of Music on Reading Comprehension in Patients With Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 18, 2017 (Actual)
Primary Completion Date
October 17, 2019 (Actual)
Study Completion Date
October 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carilion Clinic
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
The purpose of this investigation is to examine the evidence on emotion, language, and music, and propose a first step, in the form of a single-subject research design, to determine the most effective and efficient method for application to the rehabilitation of patients with aphasia. A single-subject adapted alternating treatment design will be used to compare two music conditions, using music with sung lyrics simultaneously with reading of the lyrics, and priming with music and sung lyrics followed by a reading of the lyrics, with a control condition using reading lyrics without music. Results are expected to provide evidence of independent versus shared processing of music and language at the phrase level applied to the behavior of human subjects with aphasia.
Detailed Description
Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
Data verification to assess the accuracy, completeness, or representativeness of data by comparing the data to external data sources (reliability) Data dictionary: detailed descriptions of each variable Standard Operating Procedures: patient recruitment, data collection, data management, data analysis, reporting for adverse events change management. Sample size: A minimum of four participants will be required to demonstrate replication of treatment effects. A maximum of ten participants will be requested to account for attrition.
Plan for missing data, data inconsistency,or out-of-range results. Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
left middle cerebral artery, cerebrovascular accident (CVA), stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-subject adapted alternating treatment design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music and reading lyrics
Arm Type
Experimental
Arm Description
A single-subject adapted alternating treatment design will be used to compare two music conditions, using music with sung lyrics simultaneously with silent reading of the lyrics, and priming with music and sung lyrics followed by reading of the lyrics, with a control condition using reading materials without music.
Intervention Type
Behavioral
Intervention Name(s)
Simultaneous music and reading lyrics
Intervention Description
listening to music with singing of the lyrics simultaneously with reading the written lyrics.
Intervention Type
Behavioral
Intervention Name(s)
Priming with music
Intervention Description
priming by listening to music and singing of the lyrics followed by reading the written lyrics.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
control condition using reading materials without music.
Primary Outcome Measure Information:
Title
Percent correct responses per day on phrase completion task.
Description
Differential response to the interventions (counted as the percent correct responses per day).
Time Frame
through study completion, an average of 1 year.
Title
Number of sessions required to achieve mastery.
Description
Count number of sessions.
Time Frame
through study completion, an average of 1 year.
Title
Retention of the reading material.
Description
Number of items recalled.
Time Frame
3 weeks post-intervention.
Secondary Outcome Measure Information:
Title
International Classification of Functioning, Disability, and Health (ICF) body Functions/Structures, Activities, and Participation.
Description
Pretest-posttest information on the ICF Body Functions/Structures, Activities, and Participation (Hurkmans et al., 2011).
Time Frame
through study completion, an average of 1 year.
Title
Boston Diagnostic Aphasia Examination-Third Edition (BDAE-3) (Goodglass, Harold, & Barresi, Austin: PRO-Ed.).
Description
BDAE-3 pretest-posttest reading scores on subtests: Word Identification/Word-Picture Match and Lexical Decision; Homophone Matching; Derivational and Grammatical Morphology/Matching to spoken sample; Oral Reading/Basic oral word reading; Oral Reading of Sentences with Comprehension; and Reading Comprehension-Sentences and Paragraphs. Pretest will be completed prior to baseline and initiating intervention, and posttest with be completed immediately following completion of intervention to assess generalization to non-trained stimuli.
Time Frame
through study completion, an average of 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post-hospitalization;
premorbid reading at the 8th grade level or higher based on the participant's/family's stated years of formal education;
post-stroke aphasia/left middle cerebral artery (MCA) cerebral vascular accident (CVA) based on electronic medical record (EMR) and computed tomography (CT) and/or magnetic resonance imaging (MRI) imaging reports, or consult with the neurologist;
intact left amygdala and left extrastriate cortex based on EMR and CT/MRI imaging reports, or consult with the neurologist;
reliability in answering yes-no questions as determined by an 80% score on therapy tasks during regular speech therapy;
capacity to provide informed consent concerning a study involving an intervention with music therapy determined by the physician who refers the patient.
Exclusion Criteria:
Co-morbidities diagnosed and reported in the EMR or shown on CT scan or MRI including past history of stroke in other brain regions with residual symptoms, dementia, Parkinson disease, head injury, etc.;
hemianopsia or other visual field defects affecting vision for reading, and in particular right homonymous hemi- or inferior quadrantanopsia;
previous history of learning disabilities in reading/writing;
significant psychiatric diagnosis;
English as a Second Language or non-English language.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline A. Treichler
Organizational Affiliation
Carilion Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carilion Franklin Memorial Hospital, Carilion Community Memorial Hospital Inpatient Rehab, Carilion Day Rehab
City
Rocky Mount
State/Province
Virginia
ZIP/Postal Code
24151
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Share results without sharing protected health information or participant identification.
Learn more about this trial
Effect of Music on Reading Comprehension in Patients With Aphasia
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