Effect of Music on Reading Comprehension in Patients With Aphasia
Phase: NA
Conditions: Aphasia
Sponsor: Carilion Clinic

CarilionClinic Treichler ID: IRB #2408     Effect of Music on Reading Comprehension in 
Patients With Aphasia 
SECTION III: STUDY PROTOCOL 
1.
Study Abstract: Provide a brief, non-technical summary of the study, including study purpose and
methods.
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researcher sees any signs of interference, the subject will be withdrawn from the research and study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.
2.
Background: Summarize background information about the research question(s.)  Tell why the
research is needed and include the relevance of this research to the contribution of this field of study.
Also, provide references to relevant articles in the literature.  (If you have more than 10 references,
please submit the list of references as a separate attachment.  Otherwise, please insert them here.)
Aphasia is a language disorder:
•
Caused by left cortical lesions;
•
Impacts all modalities of language including comprehension, expression, reading, and writing;
•
And affects language processing from single words through higher levels of semantic and
syntactic processing.
•
Reading has been used effectively to improve language comprehension in patients with aphasia
(Helm-Estabrooks, Albert, & Nicholas, 2014).
Emotional words facilitate language in individuals with aphasia (Landis, 2006; Landis, Graves, &
Goodglass, 1982):
•
Driven by activation of the amygdala;
•
Amygdala activation enhances memory for emotional scenes/pictures (Canli et al., 2000).
•
Lesions in the amygdala negate the emotional word response (Vuilleumier et al., 2004).
•
The amygdala also responded to nonlinguistic vocalizations (Fecteau, Belin, Joanette, & Armony,
2007).
•
The emotional word effect crosses languages (Herbert et al., 2009).
•
Labeling reduced amygdala activation and decreased affective response (Lieberman et al., 2007).
•
The emotional word effect has not been demonstrated beyond the word level.
Music also evokes emotion and activates the amygdala (Blood & Zatorre, 2001).
•
Brain regions involved in music processing are mainly supplied by the middle cerebral artery
(MCA) bilaterally (Ayotte et al., 2000).
•
Intensely emotional music activated brain structures involved in reward/motivation, emotion, and
arousal (Blood & Zatorre, 2001).
•
Musical aspects of language provide scaffolding for later development of the semantic and
syntactic aspects of language (Brandt et al., 2012).
Music has been used for rehabilitation of patients with neurological impairments.
•
The amygdala and visual extrastriate areas are intact in many patients with aphasia.
NCT 03600987           3/30/18

•
Listening to music with lyrics was more effective than listening to language for improving
language recovery in patients with aphasia in the early recovery period after stroke (Sarkamo et al.,
2008).
In the Sarkamo et al. (2008) study, sixty-three percent of the music used contained lyrics.
•
Linguistic meaning is accentuated when lyrics are embedded in music, and repeated exposure to
songs increased ratings of meaningfulness of the lyrics (Thompson & Russo, 2004).
•
Verbal material presented as song lyrics was learned and retrieved more efficiently than material
presented verbally (Thaut et al., 2005).
•
Listening to music, especially with lyrics, activated a more widely and bilaterally distributed
network than listening to verbal material alone (Callan et al., 2006).
•
Patients with aphasia repeat and recall more words from novel songs when singing than speaking
along with a model (Racette et al., 2006).
Reading was not stimulated in the Sarkamo et al. (2008) study.
•
Training more complex language can result in generalization to less complex, untrained language
(Kiran & Thompson, 2003; Thompson, Shapiro, Kiran, & Sobecks, 2003).
•
Reading is a more complex language activity than listening (Berl et al., 2011).
•
Musical training transferred to improved speech and language in children, including reading
(Moreno et al., 2008).
There is controversy in the literature regarding whether language and music networks are
independent or shared.  Resource theory:  “If two tasks demand separate resources, they will be
performed together as efficiently as in isolation…” but competitieon for the same pool of resources
would divide attention or direct attention to only one component (Bonnel, Faita, Peretz, & Besson,
2001).
1.
Evidence for independent language and music semantic processing (separate, independent
domains):
•
Patients with selective loss of linguistic abilities without any accompanying music deficit,
conversely patients with lost musical abilities who retained language.
•
Similar levels of performance were found on judgments of semantic incongruities in single-task
vs. dual task music and language processing (Bonnel, Faita, Peretz, & Besson, 2001).
2.
Evidence for shared syntactic processing:
•
Both music and language can prime the semantic meaning of a word (Koelsh et al, 2004).
•
Linguistic syntactic processing and musical syntactic processing were both impaired in patients
with aphasia (Broca’s) (Patel, Iverson, Wassenaar, & Hagoort, 2008).
•
Sung material manipulated for linguistic syntactic complexity and musical syntactic complexity
showed that more complex levels of structural integration in music and language appeared to be
shared/additive, but lower levels (not structural) were not (Fedorenko et al., 2009).
The problem:
•
Sarkamo et al. (2008) demonstrated that listening to music with lyrics was more effective than
listening to language alone to improve language recovery in patient with aphasia during the early
recovery period after a left MCA stroke.
•
The proposed next step is to test the effectiveness of additionally stimulating reading as part of
that language recovery using silent reading of the lyrics.
•
In application to treatment for patients with aphasia, will simultaneous processing of music and
language (reading) enhance or overload the processing networks?
Purpose: The purpose of this study is to translate neuroscience on emotion, music, and cognition into 
application for rehabilitation of aphasia, and test the effectiveness and efficiency of a new treatment, 
using listening to music with lyrics, combined with silent reading of the lyrics, to evoke emotion, 
engage the amygdala-extrastriate cortical projections, and increase arousal and attention to the 
reading material, to promote recovery of reading and retention of phrase-level reading material in 
patients with aphasia.   

Significance: The impact of this study is anticipated to be a demonstration of increased effectiveness 
and efficiency of therapy directed toward recovery of language including reading comprehension in 
participants with aphasia. In addition, new material will be developed to increase options for 
treatment. Further, it will provide behavioral evidence to support hypotheses of either independent or 
shared neural pathways for processing musical and linguistic semantic meaning.  
3.
Objectives: State the research hypothesis or the question that the research will answer. List the
research objectives and expected outcomes. A primary outcome or objective must be
identified. After the statement of the primary objective, secondary objectives may be listed.
Objectives should be simple and specific.
  Primary objective: test the effectiveness and efficiency of a new treatment, using listening to music 
with lyrics, combined with silent reading of the lyrics, to promote recovery of reading and retention of 
phrase-level reading material in participants with aphasia.   
Research questions: 
1.
Is music with lyrics (songs) presented simultaneously with written lyrics effective for facilitating
recovery of reading of phrase-level material for participants with aphasia (independent processing)?
2.
Is music with lyrics followed by presentation of the written lyrics effective for facilitating recovery
of reading of phrase-level material for participants with aphasia (shared processing)?
3.
Which procedure, simultaneous presentation or priming with the music/lyrics, is more effective
for facilitating recovery of reading of phrase-level material for participants with aphasia?
4.
Is one method more efficient for facilitating recovery of reading of phrase-level material for
participants with aphasia?
5.
Does one procedure result in greater retention of the trained material?
Research Hypotheses: 
1.
Music with lyrics (songs) presented simultaneously with written lyrics will be effective for
facilitating recovery of reading of phrase-level material for participants with aphasia.
2.
Music with lyrics followed by presentation of the written lyrics will also be effective for facilitating
recovery of reading of phrase-level material for participants with aphasia.
3.
Simultaneous presentation will be more effective than priming with the music/lyrics for facilitating
recovery of reading of phrase-level material for participants with aphasia.
4.
Simultaneous presentation will be more efficient for facilitating recovery of reading of phrase-
level material for participants with aphasia.
5.
Simultaneous presentation will result in greater retention of the trained material.
4.
Study Design: Give a description of the research design including use of placebo, randomization
and an explanation of what is experimental. Include type of study: descriptive, retrospective, cross-
sectional, longitudinal, prospective observational, pilot, experimental (controlled or non-controlled) or
pilot.
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.
5.
Study Population: Describe the subject population, including age, gender, ethnic characteristics
and health status. State the inclusion/exclusion criteria along with how this was determined, and by
whom. Please state whether pregnant women, children, or other vulnerable groups will be included
or excluded.  Provide rationale for using or excluding special populations.  State the number of
subjects or subject records necessary to complete the research.

Considerations in Participant Selection 
   The main neurological structures that must remain intact for the proposed treatment to work are 
lateralized left hemispheric, i.e. left amygdala and left extrastriate cortex. While it seems intuitive to 
choose patients with right cerebral vascular accident (CVA) as the trial subjects, deeper analysis of 
the fMRI results reveals that areas on the right middle and superior temporal gyri and bilaterally the 
superior parietal gyrus post central were simultaneously activated. In addition, it has been shown 
that reading comprehension is bilaterally organized. For example, Hauk et al. revealed that words are 
processed by distributed neuronal networks that reflect word semantics (Hauk, Johnsrude, & 
Pulvermuller, 2004). Specifically, event-related fMRI showed that action words/verbs presented in 
passive reading differentially activated areas in the motor strip involved in the actual movements. 
Further, the left hemispheric structures involved in re-entrant processing are not part of the primary 
speech/language areas, i.e. Broca’s, conduction, or Wernicke’s areas. Therefore, the population of 
subjects who could most benefit from the proposed treatment should be those with localized cortical 
aphasia. 
   Because the identification of the intact targeted structures, i.e. left amygdala to left extrastriate 
cortex, is the basis for inclusion in this study, signs/symptoms defining injury to those neuro-
anatomical structures should also be the basis of exclusion criteria. Type of aphasia need not be a 
limiting factor. In single-subject research design, each subject serves as his/her own control, so 
severity levels need not be defining criteria, because the effect on the outcomes of both treatments 
would be the same. Hemianopsia or other visual field defects, unilateral hemi-neglect or inattention 
affecting vision for reading need to be excluded, and in particular right homonymous hemi- or inferior 
quadrantanopsia which would indicate a lesion of the left parietal or temporal lobes and involvement 
of the left optic radiations. 
Inclusion Criteria 
   Participants will be 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) CVA based on EMR and CT/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 a 80% score on yes/no 
comprehension therapy tasks during regular speech therapy. 
Capacity to provide informed consent concerning a study involving an intervention with music 
therapy.   
     This will be determined by the physician who refers the patient. The physician's determination will 
be documented either through written communication with the researcher, including emails, or by a 
note to file by the researcher that documents a verbal communication from the physician. 
Exclusion criteria 
   Co-morbidities diagnosed and reported in the EMR or shown on CT scan or MRI including past 
history of stroke affecting other brain areas with residual symptoms, dementia, Parkinson’s 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. 
Sample Size    
   A minimum of four participants will be required to demonstrate replication of treatment effects 
(Gast & Ledford, 2014, p.327). A maximum of ten participants will be requested from the IRB to 
account for attrition. 
6.
Methodology: List all activities or procedures that will be performed (pre-treatment tests and
medications, tests and medications used during therapy, diagnostic tests, x-rays, lab tests,

questionnaires and other forms, interviews, chart reviews etc.) Describe how, when and where 
research activities will be administered and analyzed.  Distinguish any standard processes from 
those that are research.  Please describe activities/procedures in a step-by-step chronological 
order. State the length of time subjects will be in the study and the expected amount of time 
required for each study visit or activity. 
Procedures: 
Research procedures for the study are described below. None of these procedures will be billed to 
the patient or third party insurers. When the patient is seen at CFMH Rehab or Roanoke Day Rehab, 
during the song testing, baseline, and intervention phases, the subject's normal speech therapy 
sessions will be cut from approximately 60 to 45 minutes. The research interventions will immediately 
follow. The research sessions will take, on average, an additional 45 minutes. When seen at CRCH 
Inpatient Rehab, the speech therapy sessions will not change other than reading. The Inpatient 
Rehab SLPs will receive the referral for ST and conduct an initial evaluation of patients for clinical 
purposes. This will include standard testing procedures for speech/language and swallowing. Patients 
with a diagnosis of left MCA CVA will be identified using the inclusion-exclusion checklist by the 
Inpatient Rehab SLPs who will then inform patients of the study and ask at a standard speech 
therapy session if the patient and legally authorized representative or person of the patient's 
choosing would agree to meet, via Carilion Secure Videoconferencing, with the Rehab Director to 
discuss the possibility of being in a research study. The treating SLP will notify the recruiter of the 
patient’s decision. If the patient is recruited, the PI will be notified by the recruiter and the PI will 
schedule and conduct the Informed Consent interview. All research interventions will be scheduled 
after 2:30 pm and conducted by the PI onsite.   
   First Step--ST evaluation (standard procedure) and identification based on inclusion/exclusion 
criteria.  (Expected length of time one visit). 
   Second Step—At CFMH Outpatient, Recruitment interview with Rehab Director. The treating SLP 
will inform the PI of new referrals. The PI will then check the EMR for preselection, and inform the 
recruiter of appropriate referrals to be contacted for recruitment. The Rehab Director will contact the 
potential participant to discuss the possibility of being in a research study. If the 
patient/representative agree, then a mutually agreeable time will be scheduled, probably before or 
after a standard therapy visit. The Rehab Director will notify the speech therapist researcher of the 
patient's decision on whether to further discuss participation in research.
   AT CRCH Inpatient Rehab treating SLPs, which does not include the researcher, will inform patients 
of the study and ask at a standard speech therapy session if the patient and legally authorized 
representative or person of the patient's choosing would agree to meet, via Carilion Secure 
Videoconferencing, with the Rehab Director to discuss the possibility of being in a research study. 
The treating SLP will notify the recruiter of the patient’s decision. If the patient/representative agree, 
then a mutually agreeable time will be scheduled.  
   At Roanoke Day Rehab the PI may or may not be the treating therapist. If the PI is the treating 
speech therapist, procedures to CFMH Oupatient will be followed. If the PI is not the treating 
therapist, procedures will mirror those used at CRCH Inpatient Rehab. The PI will set up the 
conference call but will not be present in the meeting, unless requested to come back in to assist 
given any problem with equipment. (Expected length of time one visit). 
   Third Step--Informed consent interview with SLP outside the patient's normal treatment time. SLP 
researcher will review consent document with patient and patient's representative. The informed 
consent discussion is expected to take 45 to 60 minutes. Patient will answer yes/no comprehension 
questions regarding the information presented, which will be documented in writing by the SLP 
researcher. Any questions answered in error will prompt a review of the information by the SLP. If 
the patient scores less than an average of 80% on the yes/no comprehension test after the review, 

the patient will not be asked to participate in the study. Patient will have three days to review 
consent document at home and make a decision. (Expected length of time one visit plus three days) 
   Fourth Step--Administer pretest Boston Diagnostic Aphasia Examination (BDAE-3) full version 
Reading subtests (extended testing). (Expected length of time one visit) 
   Fifth Step--All songs will be pretested for familiarity and positive valence by questioning the 
participants (i.e. do you know this song?  Do you like it?). Response data will be recorded.  (Expected 
length of time 1-2 visits) 
   Sixth Step--Baseline phase, all 30 phrases (see attachment 1) will be tested using the phrase 
completion task (see attachment 2). Both correct responses and participation will be verbally 
reinforced. Results will be analyzed by the ST to ensure that the sets are of equal difficulty for each 
participant.  (Expected length of time 5 visits or 2 weeks) 
   Seventh Step--Intervention phase (B) (see flowchart attached), each song (music with lyrics) from 
set 1 (B1 songs#1-10) will be played in its entirety. When the targeted verse or chorus plays, the 
written lyrics will be simultaneously shown along with the song lyrics. The ST will point to the words 
of the targeted verse/chorus which will be silently observed by the participant as they are sung. This 
will be repeated for all 10 songs. The phrase completion task will then be presented, including the 
ten phrases from the songs played that day and the five control phrases, without music. The 
participant will silently or orally read the phrase and orally read and/or circle or point to the phrase 
completion choice. Correct responses will be verbally reinforced. The next session, each song (music 
with lyrics) from set 2 (B2 songs #11-20) will be played in its entirety. After the song plays, the 
written lyrics from the targeted verse or chorus will be presented. The ST will point to the words of 
the targeted verse/chorus which will be silently observed by the participant. This will be repeated for 
all 10 songs. The phrase completion task will then be presented, including the ten phrases played 
that day and the five control phrases. The participant will silently or orally read the phrase and orally 
read and/or circle or point to the phrase completion choice. Correct responses will be verbally 
reinforced. This will be repeated for all 10 songs. For all interventions, the number of correct 
responses will be tallied on a LaPoint Base 10 form and the percent correct will be entered on the 
graph for that day. The same procedures will be repeated, alternating procedures on sets 1 and 2 on 
subsequent treatment visits, until a criterion of 9/10 (90%) x 3 consecutive visits is reached on both 
sets. If the criterion is not reached on one of the intervention sets, defined as no increase in 
percentage correct x 3 consecutive visits, a correction procedure will be applied using modeling of the 
correct response. If the criterion still is not reached, that intervention will be determined to be limited 
in effectiveness and discontinued. Every third session will be videotaped for a reliability check by the 
recruiter/research team member. When both of the sets (B1 and B2) have been acquired or one 
acquired and the other discontinued, the number of sessions to criterion will be counted for each 
intervention.  (Expect length of time 2- 12 weeks) 
   Eighth Step--Posttest BDAE-3 full version Reading subtests (extended posttest).  (Expected length 
of time one visit) 
   Ninth Step--Retest retention of 30 phrases 3-week follow-up.  (Expected length of time one visit) 
       Total number of visits:  16-48; total length of time 10-20 weeks per patient. 
   For CFMH or Roanoke Day Rehab, the PI, who is also the treating SLP, will make clear to subjects 
each time when standard therapy has ended and a research study intervention is about to begin. The 
subjects will be told approximately how long the research intervention is expected to take. For CRMH 
Inpatients, research will be separated in time and completed by a different SLP (the PI). 

7.
Data Collection: Attach a copy of your data collection tool or spreadsheet listing exactly what data
is to be gathered during this research study.  Describe below the data collection methods and how
data be compiled for assessment.
Outcome Measures and Time Points
   Pretest/post-test information on the ICF Body Functions/Structures, Activities, and Participation will 
be provided (Hurkmans et al. 2011). 
   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.  
   At three weeks follow-up the trained stimuli from all three interventions will be retested to assess 
retention (see Flow Diagram).  
   The dependent variables, i.e. differential response to the two interventions (counted as the percent 
correct responses per day, number of sessions required to achieve mastery at each level (simple 
counting), retention of the material (number of items remembered). 
Reporting Participant Characteristics 
   Age; sex; time post onset of left MCA CVA; type of stroke; previous level of function including 
educational level; body functions/structures, activities, and participation will be reported for previous 
level of function and changes from the stroke per the World Health Organization (WHO) International 
Classification of Functioning Disability and Health (ICF) (World Health Organization, 2013). 
   A meta-analysis of studies using music for the treatment of neurological language and speech 
disorders showed that although measurable improvement was reported, the methodological quality of 
studies was rated low (Hurkmans et al., 2011). Specific recommendations were made to report 
education, dominance, and musical background, all of which will be included in the current study.  
Education will be reported based on highest level of formal education attained. Dominance will be 
determined by premorbid handedness for writing.  Musical background will include reporting previous 
formal instruction for singing/choir, playing an instrument, or reading music, and experience with 
performance of singing, dancing, and listening to music. 
Carilion Clinic’s REDCap software will be used as the central location for data collection.  REDCap 
(research electronic data capture) provides a secure, web-based application designed to support data 
management and collection for research/QA/QI studies.  Carilion’s REDCap servers are securely 
housed on site in a limited access data center, and all data are stored on Carilions’s firewall protected 
network.  The Health Analytics Research Team suppports the proper development of projects and 
surveys in REDCap, observing appropriate change control and enforcing appropriate security controls.  
Data collection projects are built with a study-specific data dictionary, enforcing intuitive, accurate, 
consistent and complete data entry.  REDCap also provides a survey tool for building and managing 
online surveys.  Health Analytics Research team restricts user access to the IRB-approved project 
research team utilizing the approved processes and standards of TSG.  REDCap is HIPAA compliant 
and provides audit trails.  Data can be easily exported in several formats to a secure network 
directory for combination with extracted data, if appropriate, and analysis with common statistical 
packages. 
8.
Statistical Analysis: State how qualitative and/or quantitative data will be analyzed. This must
include a statement from a statistician that there is sufficient power to determine the primary study

outcome or objective. Other outcomes may be listed as secondary and descriptive. If this is a proof 
of concept or feasibility study that includes limited efficacy testing, there must be a statistician 
statement that the appropriate design is in place to determine whether an intervention should be 
recommended for broader efficacy testing. If a study is meant to be solely descriptive, then results 
apply only to the sample being studied and conclusions cannot be drawn about the larger population; 
therefore, the primary outcome or objective must be limited in scope. 
Data Analysis 
   Reliability of the items in the task assessment tool will be established using Cronbach’s Alpha 
correlation coefficient once at the beginning of the baseline phase. Inter-observer reliability on the 
scoring of the tool will be determined weekly using the kappa coefficient, a.k.a. Cohen's Kappa. 
Reliability data will first be analyzed for normality/skewness, accuracy, and completeness. Outliers 
will be identified using the Outlier Labeling Rule based on rank and percentile. If data are incomplete, 
e.g. if the behavior cannot be clearly seen on the digital recording, the corresponding score from the
other researcher will be eliminated from the reliability determination.
   The correlation coefficient chosen is dependent on the scale of measurement of the variables being 
correlated. For the reliability of the task assessment tool it will be used to determine if scores 
recorded by one researcher are strongly correlated with scores recorded by the other. Scores will be 
recorded as correct vs. incorrect, which is a nominal scale. One classic correlation coefficient used 
with a nominal scale is Cronbach’s Alpha, used when both X and Y are dichotomous variables. The 
assumption that the items of the test are unidimensional cannot be met, meaning that each item 
measures the same ability on the same scale, because many different mental processes may be used 
in various combinations from item to item. Cronbach’s alpha provides a solution to this problem, so 
will be an appropriate measure of internal consistency (Cronbach, 2004, see p.8). Acceptable values 
of alpha range from .70 to .90 (Tavakol & Dennick, 2011). If alpha is below .70, either the task 
assessment tool will be revised or the assistant will be re-instructed. 
Inter-observer reliability will be determined by the kappa coefficient, used when there are two 
observers. Again scores will be recorded as correct vs. incorrect, a nominal scale. Simple percent 
agreement cannot account for chance agreement/uncertainty. The kappa statistic was developed to 
control for random agreement. Interpretation will be based on the kappa coefficient squared to show 
the accuracy in the data due to conguence between data collectors. Acceptable kappa squared values 
will range from .90-1.00 (McHugh, 2012). If the accuracy is questionable, the cause will be 
determined, and may indicate the need for further instruction of the assistant(s) on data collection. If 
reliability is below simple percent agreement 80% or kappa squared .90 on any day, the recording 
will be reviewed again by both researchers and consensus reached.  
   Data analysis for treatment will include both visual analysis and quantitative statistical analysis as 
follows:  
•
Visual analysis will include graphing average (mean) correct responses on the multiple-choice
reading comprehension questions each session during each phase. Trend will be described by
celeration lines depicting slope in each phase with split middle lines to measure central tendency.
•
Quantitative statistical analysis will include the binomial test for dichotomous outcomes, the two
standard deviations band method, and statistical process control.
•
The binomial test involves counting data points above and below the split middle line and
comparing the total number of points above and below with the number with fewer points to
determine Spearman’s Rank Correlation Coefficient, one-tailed probabilities which show whether the
response pattern could have occurred by chance (<0.05 is considered significant) (Portney &
Watkins, 2009).
•
Computer analysis will include statistical process control, to determine whether intervention
represents special cause variation. Statistical process control plots the central line and upper- and
lower-control limits at three standard deviations above and below the mean. Criteria for special

cause/significance include: 1) any point that falls outside the upper or lower control limits; 2) seven 
or more consecutive points all above or below the center mean line, called a “run;” 3) six or more 
consecutive points moving up or down across the center mean line, called a “trend” (Portney & 
Watkins, 2009).  
•
The difference in number of sessions/trials to achieve mastery at each level for each intervention,
the difference in retention at three weeks follow-up, and generalization to words used in verbal
expression, will be analyzed by comparison of the difference between data points for the control
treatment and the two target intervention conditions. After the research design has been completed
by a minimum of four subjects, data will be consolidated for group means.
Statistical review was conducted by: Thomas Cappaert, PhD, ATC, CSCS 
 (name of statistician)  
Professor & Director of Post-Professional Research, Rocky 
Mountain University of Health Professions      (Department/Institution of statistician)