Trial Outcomes & Findings for Word-Retrieval Treatment for Aphasia: Semantic Feature Analysis (NCT NCT00125242)

Results Overview

Accuracy of naming of pictured treated and untreated items was assessed in probes conducted separate from treatment. Probes were conducted repeatedly throughout the study, from baseline (prior to treatment) to follow-up (6 weeks following treatment). All naming responses were scored using a 0-10 scale reflecting promptness and presence of errors; scores of 8-10 received an "accuate" score and scores of 0-7 received an "inaccurate" score. A percentage accuracy score was calculated for each experimental set of items for every probe session. Baseline probe scores were compared to end of treatment and follow-up probe scores to obtain individual effect sizes for each experimental list of items for each participant (i.e., several effect sizes were calculated for each participant). All effect sizes were utlized to obtain an average effect size for each participant; these averages were then utlized to obtain a group average.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

110 participants

Primary outcome timeframe

End of treatment and at 6 weeks post treatment

Results posted on

2014-12-24

Participant Flow

Participant milestones

Participant milestones
Measure	Non Treatment Stimuli Development Participants Non-brain-injured participants who were enrolled for the purpose of stimuli development	SFA Treatment Participants Stroke survivors who received experimental therapy
Overall Study STARTED	94	16
Overall Study COMPLETED	87	14
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Non Treatment Stimuli Development Participants Non-brain-injured participants who were enrolled for the purpose of stimuli development	SFA Treatment Participants Stroke survivors who received experimental therapy
Overall Study did not qualify	7	2

Baseline Characteristics

Word-Retrieval Treatment for Aphasia: Semantic Feature Analysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SFA Treatment Participants n=16 Participants Semantic Feature Analysis (SFA) is a word-retrieval treatment for aphasia. SFA entails having the speech-language pathologist (SLP) guide the participant through generation of pertinent semantic features for pictured treatment items (e.g., category membership, physical description, location of item in context, personal associations, associated actions). For some participants, treatment items were grouped by typicality of category membership (e.g, robin-typical bird and penguin-atypical bird). Training of atypical items may stimulate a broader semantic activation of the category and thus, may promote greater generalization. Treatment was applied sequentially to sets of items in single-subject, multiple baseline designs. Thus, replication of treatment effects could be evaluated within and across participants. Treatment was administered by SLPs three times per week until prescribed accuracy levels were met during probes or a maximum number of treatment sessions was completed.	Non Treatment Stimuli Development Participants n=94 Participants Participants for stimuli development provided normative data for stimuli development. e.g., Treatment items were grouped according to typicality of category membership (apple - typical fruit; coconut - atypical fruit). These participants provided the reponses that served as the basis for classifying/organizing stimuli. Because data from this group were used only for the purposes of stimuli development, no findings are reported for this group. See Cameron, R.M., Wambaugh, J.L., \& Mauszycki, S. (2008). Effects of age, gender and education on semantic fluency for living and artifact categories. Aphasiology, 22(7/8), 790-801, doi: 10.1080/02687030701818018 for related findings.	Total n=110 Participants Total of all reporting groups
Age, Customized 21-80 Years	16 participants n=5 Participants	94 participants n=7 Participants	110 participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	47 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	47 Participants n=7 Participants	59 Participants n=5 Participants

PRIMARY outcome

Timeframe: End of treatment and at 6 weeks post treatment

Population: SFA Treatment Participants were stroke-survivors with chronic aphasia who had significant word retrieval difficulties. Non Treatment Stimuli Development Participants were only enrolled in the study to provide data for the development of treatment stimuli. As such, they were not assessed for the outcome measure.

Accuracy of naming of pictured treated and untreated items was assessed in probes conducted separate from treatment. Probes were conducted repeatedly throughout the study, from baseline (prior to treatment) to follow-up (6 weeks following treatment). All naming responses were scored using a 0-10 scale reflecting promptness and presence of errors; scores of 8-10 received an "accuate" score and scores of 0-7 received an "inaccurate" score. A percentage accuracy score was calculated for each experimental set of items for every probe session. Baseline probe scores were compared to end of treatment and follow-up probe scores to obtain individual effect sizes for each experimental list of items for each participant (i.e., several effect sizes were calculated for each participant). All effect sizes were utlized to obtain an average effect size for each participant; these averages were then utlized to obtain a group average.

Outcome measures

Outcome measures
Measure	SFA Treatment Participants n=68 participant effect sizes Stroke survivors received Semantic Feature Analysis for the treatment of word-retrieval deficits. Each SFA treatment participant received word-retrieval therapy applied sequentially to experimental lists of items. Effect sizes were calculated for each participant for each list. An average effect size was calculated for each participant and an overall average was determined for all participants as a group.
Word Retrieval Accuracy	7.15 d-index (effect size) Standard Deviation 3.1

Adverse Events

SFA Treatment Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NonTreatment Stimuli Development Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Julie Wambaugh

VA Salt Lake City Health Care System

Phone: 801-582-1565

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place