NCT03600987

Effect of Music on Reading Comprehension in Patients With Aphasia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Carilion Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aphasia

Interventions

Type	Name	Description
BEHAVIORAL	Simultaneous music and reading lyrics	listening to music with singing of the lyrics simultaneously with reading the written lyrics.
BEHAVIORAL	Priming with music	priming by listening to music and singing of the lyrics followed by reading the written lyrics.
BEHAVIORAL	Control	control condition using reading materials without music.

Timeline

• Start date: 2017-10-18
• Primary completion: 2019-10-17
• Completion: 2019-10-17
• First posted: 2018-07-26
• Last updated: 2020-01-06

Locations

1 site across 1 country: United States