Trial Outcomes & Findings for A Novel Treatment for Aphasia and Apraxia of Speech : Measurement of Outcomes (NCT NCT01979159)
NCT ID: NCT01979159
Last Updated: 2019-06-19
Results Overview
Correct Information Units (CIUs) is a measure of the amount of relevant content produced in connected language tallied according to operationalized criteria. CIU is not a test or scale - it is a measure that is applied to language samples - in this case, description of treated pictures. Participants described experimental pictures, responses were transcribed and CIUs counted. CIUs can range from 0 to an unlimited maximum. Effect sizes (ESs) were calculated as an indication of the magnitude of change in number of CIUs produced (pre treatment to post treatment. ESs can range from negative (poorer performance post-treatment) to positive values (better performance post-treatment), with larger positive values reflecting greater gains. Benchmarks are as follows: \>11.14 = large, 11.13 - 6.56 = medium, 6.55 - 3.88 = small, \<3.88 = negligible. Small to large ESs indicate production of measurably more CIUs in picture descriptions post-treatment. Larger the ES, the greater the change.
COMPLETED
NA
4 participants
Following completion of treatment at 6 weeks post
2019-06-19
Participant Flow
Participant milestones
| Measure |
Combined Aphasia and Apraxia of Speech Treatment (CAAST)
CAAST was administered to 4 persons with aphasia and apraxia of speech in the context of single-subject designs
Combined Aphasia and Apraxia of Speech Treatment (CAAST): Therapy is delivered in a face-to-face format. The therapist uses picture stimuli, verbal modeling, feedback, reinforcement, forward-chaining to increase verbal production. For speech errors that occur, the therapist uses modeling, feedback, reinforcement, simultaneous production, articulatory instruction, and repeated practice to improve articulation.
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|---|---|
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Overall Study
STARTED
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4
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Overall Study
COMPLETED
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4
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Novel Treatment for Aphasia and Apraxia of Speech : Measurement of Outcomes
Baseline characteristics by cohort
| Measure |
Combined Aphasia and Apraxia of Speech Treatment (CAAST)
n=4 Participants
Speakers with chronic aphasia and apraxia of speech who received the experimental treatment
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|---|---|
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Age, Continuous
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51 years
n=93 Participants
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Sex: Female, Male
Female
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2 Participants
n=93 Participants
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Sex: Female, Male
Male
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2 Participants
n=93 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=93 Participants
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Race (NIH/OMB)
White
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3 Participants
n=93 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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Region of Enrollment
United States
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4 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Following completion of treatment at 6 weeks postCorrect Information Units (CIUs) is a measure of the amount of relevant content produced in connected language tallied according to operationalized criteria. CIU is not a test or scale - it is a measure that is applied to language samples - in this case, description of treated pictures. Participants described experimental pictures, responses were transcribed and CIUs counted. CIUs can range from 0 to an unlimited maximum. Effect sizes (ESs) were calculated as an indication of the magnitude of change in number of CIUs produced (pre treatment to post treatment. ESs can range from negative (poorer performance post-treatment) to positive values (better performance post-treatment), with larger positive values reflecting greater gains. Benchmarks are as follows: \>11.14 = large, 11.13 - 6.56 = medium, 6.55 - 3.88 = small, \<3.88 = negligible. Small to large ESs indicate production of measurably more CIUs in picture descriptions post-treatment. Larger the ES, the greater the change.
Outcome measures
| Measure |
Combined Aphasia and Apraxia of Speech Treatment (CAAST)
n=4 Participants
CAAST was administered to 4 persons with aphasia and apraxia of speech in the context of single-subject designs.
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|---|---|
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Change in Language Content Production for Treated Stimuli: Effect Sizes (Magnitude of Change From Baseline to Follow-up)
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13.38 units on a scale
Interval 1.54 to 42.77
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PRIMARY outcome
Timeframe: baseline (prior to treatment) through follow-up at 6 weeks post treatmentPopulation: One participant received treatment on all sets; consequently, generalization to an untreated set could not be calculated
Correct Information Units (CIUs) is a measure of the amount of relevant content produced in connected language tallied according to operationalized criteria. CIU is not a test or scale - it is a measure that is applied to language samples - in this case, description of untreated pictures. Participants described experimental pictures, responses were transcribed and CIUs counted. CIUs can range from 0 to an unlimited maximum. Effect sizes (ESs) were calculated as an indication of the magnitude of change in number of CIUs produced (pre treatment to post treatment. ESs can range from negative (poorer performance post-treatment) to positive values (better performance post-treatment), with larger positive values reflecting greater gains. Benchmarks are as follows: \>9.53 = large, 9.52 - 5.52 = medium, 6.55 - 3.29 = small, \<3.29 = negligible. Small to large ESs indicate production of measurably more CIUs in picture descriptions post-treatment. Larger the ES, the greater the change.
Outcome measures
| Measure |
Combined Aphasia and Apraxia of Speech Treatment (CAAST)
n=3 Participants
CAAST was administered to 4 persons with aphasia and apraxia of speech in the context of single-subject designs.
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Change in Production of Language Content for Untreated Sets - Generalization Measured in Effect Sizes
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7.99 units on a scale
Interval 0.89 to 15.54
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SECONDARY outcome
Timeframe: pre and post treatment - prior to the start of treatment and at 6 weeks following the completion of treatmentPopulation: Change in percent of words that were intelligible
Speech intelligibility (understandability of speech) was measured by having participants produce 50 words from the Assessment of Intelligibility of Dysarthric Speech (ASSIDS) Two speech-language (blinded) scored pre and post treatment ASSIDS samples. The percentage of words correctly understood was calculated for each participant. The ASSIDS is not a scale - it is a procedure for calculating intelligibility. Speech intelligibility can range from 0% to 100% intelligible (no words understood to all words understood). The higher the percentage, the better the speech is understood by the listener. Change in percent words intelligible has the potential to be a negative (reflecting a poor outcome of less intelligible speech) or positive (reflecting a good outcome of more intelligible speech). The maximum possible amount of gain in intelligibility for these 4 participants, based on their pretreatment performance, ranged from +2% to +25%.
Outcome measures
| Measure |
Combined Aphasia and Apraxia of Speech Treatment (CAAST)
n=4 Participants
CAAST was administered to 4 persons with aphasia and apraxia of speech in the context of single-subject designs.
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|---|---|
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Changes in Speech Intelligibility on the Assessment of Intelligibility of Dysarthric Speech
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6.75 percentage of change-intelligible words
Interval 0.0 to 10.0
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Adverse Events
Combined Aphasia and Apraxia of Speech Treatment (CAAST)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place