Aphasia Clinical Trial
Official title:
Effect of Music on Reading Comprehension in Patients With Aphasia
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.
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