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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
listening to music with singing of the lyrics simultaneously with reading the written lyrics.
priming by listening to music and singing of the lyrics followed by reading the written lyrics.
control condition using reading materials without music.
Carilion Franklin Memorial Hospital, Carilion Community Memorial Hospital Inpatient Rehab, Carilion Day Rehab
Rocky Mount, Virginia, United States
Percent correct responses per day on phrase completion task.
Differential response to the interventions (counted as the percent correct responses per day).
Time frame: through study completion, an average of 1 year.
Number of sessions required to achieve mastery.
Count number of sessions.
Time frame: through study completion, an average of 1 year.
Retention of the reading material.
Number of items recalled.
Time frame: 3 weeks post-intervention.
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).
Time frame: through study completion, an average of 1 year.
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.
Time frame: through study completion, an average of 1 year.
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