Clinical Trial: Effect of Music on Reading Comprehension for Patients With Aphasia

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Effect of Music on Reading Comprehension for Patients With Aphasia

Brief Summary: This investigation uses a single-subject, adapted alternating research design to compare two different experimental conditions using music with lyrics combined with visual stimulation of the written lyrics, to extend the emotional word effect to phrases, in order to stimulate reading comprehension of the trained material for patients with aphasia. The two music conditions include 1) music with sung lyrics simultaneously with silent reading of the written lyrics; and 2) music with sung lyrics, followed by silent reading of the written lyrics (i.e. priming with the music). A control set without music will be used additionally within every third session to detect potential history and maturation effects. All conditions will be followed by a silent reading phrase-completion task composed of written words from the total combined sets of stimuli.

Detailed 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 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. Risks are expected to be minimal. The risk is confidentiality. Risk management procedures in this study include: assuring confidentiality of participants, assuring qualified personnel, assuring convenient location, ensuring adequate enrollment, continual monitoring, addressing potential conflicts of interest, and making a plan to manage problems. Continual monitoring will be used to assess whether study interventions appear to be interfering with normal speech therapy treatment. If the researcher sees any signs of interference, the subject will be withdrawn from the research and study interventions will be stopped.
Sponsor: Carilion Clinic

Current Primary Outcome:

• Percent correct responses per day on phrase completion task. [ Time Frame: through study completion, an average of 1 year ]
  Differential response to the interventions (counted as the percent correct responses per day.
• Number of sessions required to achieve mastery. [ Time Frame: through study completion, an average of 1 year ]
  count number of sessions.
• Retention of the reading material [ Time Frame: 3 weeks post-intervention. ]
  Number of items recalled.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• International Classification of Functioning, Disability, and Health (ICF) Body Functions/Structures, Activities, and Participation [ Time Frame: through study completion, an average of 1 year ]
  Pretest/post-test information on the ICF Body Functions/Structures, Activities, and Participation (Hurkmans et al. 2011).
• Boston Diagnostic Aphasia Examination (BDAE) [ Time Frame: through study completion, an average of 1 year ]
  The Boston Diagnostic Aphasia Examination (BDAE) (Goodglass, Harold, & Kaplan, 1983): Pretest reading scores on the BDAE full version subtests, i.e. B. Word Identification: 1. Word-Picture Match, and 2. Lexical Decision; C. 1. Homophone Matching; D. Derivational and Grammatical Morphology: 1. Matching to spoken sample; E. Oral Reading: 1. Basic oral word reading; F. Oral Reading of Sentences with Comprehension; and G. Reading Comprehension-Sentences and Paragraphs; will be completed prior to baseline A and initiating intervention, and immediately following completion of intervention to assess generalization to non-trained stimuli.

Original Secondary Outcome: Same as current

Information By: Carilion Clinic

Dates:
Date Received: August 10, 2016
Date Started: July 2016
Date Completion: June 2017
Last Updated: August 18, 2016
Last Verified: August 2016