An interventional study of Combined Aphasia and Apraxia of Speech Treatment (CAAST) in Apraxia of Speech and Aphasia, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-06-19.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
Among 39 studies in Apraxias with a site in United States — 13 open to participants now, 18 under way, none of them phase 3. Apraxias · United States.
Among the 39 studies in Apraxias with a site in United States, this one is the 27th largest by enrollment of the 29 interventional ones that give a count, is one of 2 that started in 2013, is one of 21 with no phase, and was the 8th registered.
65 studies on the registry are indexed under Apraxias; 21 are open to participants now.
Browse Apraxias studies →13 of the 39 studies in Apraxias with a site in United States are open now. Recruiting first, the newest first:
New York University · Sites in United States
University of Central Florida · Sites in United States
MGH Institute of Health Professions · Sites in United States
University of Central Florida · Sites in United States
Stephanie Grasso · Sites in United States, Spain
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 14 Apraxias studies recruiting now, 5 (36%) set no upper age limit and 7 (50%) stop at 75 or younger; 6 take children under 18; 2 take healthy volunteers.
This study: 21 Years to 75 Years · all sexes · no healthy volunteers.
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39 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 3 · Phase 4 2
First in 1992; this study’s year is marked. 2 started in 2013.
This study's enrollment of 4 is below the median of 32 across 50 interventional studies indexed under Apraxias.
Median enrollment 34 across the 29 interventional studies, 180 across the 9 observational. Of the 18 that completed or were terminated, 11 (61%) have results posted.
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1 of 39 have an industry lead sponsor. The 10 most frequent:
VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
VA Office of Research and Development has 4 studies filed under Apraxias — fewer than ten, so there is no comparison to draw.
5 of the studies in Apraxias with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07563387University of FloridataVNS for Speech and Language Recovery in Aphasia | 2027-01-01 |
| NCT05368350The University of Texas at DallasTreating Primary Progressive Aphasia and Apraxia of Speech Using Non-invasive Brain Stimulation | 2027-04-16 |
| NCT03452202NYU Langone HealthUsing tDCS in Speech-based Stroke Rehabilitation | 2027-04-30 |
| NCT03313011Mayo ClinicThe Neurobiology of Two Distinct Types of Progressive Apraxia of Speech | 2027-07 |
| NCT05741853Stephanie GrassoCognitive Reserve and Response to Speech-Language Intervention in Bilingual Speakers With Primary Progressive Aphasia | 2027-11-30 |
Among the 39 studies in Apraxias with a site in United States, from their registry updates:
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In order to determine if speech-language therapy has positive effect, reliable measurement tools are required to document outcomes. Currently, there is very limited information concerning the measurement of changes in speech production as a result of treatment for acquired apraxia of speech and aphasia. This study will obtain information concerning the reliability of several speech production measures over time. Thirty persons with chronic aphasia and apraxia of speech will be asked to provide speech samples in response to commonly used assessment tools on three sampling occasions so that the stability of measurements may be examined.
After establishment of appropriate outcome measures, a small, pilot treatment study will be conducted with four participants. The participants will receive a new treatment for aphasia and acquired apraxia of speech and outcomes will be measured relative to speech and language production.
A single group, repeated measures design will be used to obtain repeated speech samples from 30 persons with chronic acquired apraxia of speech and aphasia. Speech samples will be elicited using commonly employed motor speech assessment protocols; an initial sample, a sample one week following the initial sample, and a sample at four weeks following the initial sample. The following measures will be obtained from the samples: percent consonants correct, percent fluent utterances, and duration of utterance. Stability of the measures will be examined.
After the preceding measures have been analyzed, a series of four, single-subject experimental designs will be conducted. Four participants with chronic aphasia and apraxia of speech will receive a new treatment for aphasia and apraxia of speech applied sequentially to two sets of experimental picture picture stimuli. Outcomes will be measured in terms of speech production (measures described above) as well as in terms of language production.
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Exclusion Criteria:
Administration of Combined Aphasia and Apraxia of Speech Treatment )(CAAST) to 4 persons with aphasia and apraxia of speech in the context of single-subject designs
Behavioral: 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.
Also known as: CAAST
Change in Language Content Production for Treated Stimuli: Effect Sizes (Magnitude of Change From Baseline to Follow-up)
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.
Time frame: Following completion of treatment at 6 weeks post
Change in Production of Language Content for Untreated Sets - Generalization Measured in Effect Sizes
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.
Time frame: baseline (prior to treatment) through follow-up at 6 weeks post treatment
Changes in Speech Intelligibility on the Assessment of Intelligibility of Dysarthric Speech
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%.
Time frame: pre and post treatment - prior to the start of treatment and at 6 weeks following the completion of treatment
| Milestone | Combined Aphasia and Apraxia of Speech Treatment (CAAST) |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
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.
| units on a scale | Combined Aphasia and Apraxia of Speech Treatment (CAAST) |
|---|---|
| Change in Language Content Production for Treated Stimuli: Effect Sizes (Magnitude of Change From Baseline to Follow-up) | 13.38 (1.54 to 42.77) |
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.
| units on a scale | Combined Aphasia and Apraxia of Speech Treatment (CAAST) |
|---|---|
| Change in Production of Language Content for Untreated Sets - Generalization Measured in Effect Sizes | 7.99 (.89 to 15.54) |
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%.
| percentage of change-intelligible words | Combined Aphasia and Apraxia of Speech Treatment (CAAST) |
|---|---|
| Changes in Speech Intelligibility on the Assessment of Intelligibility of Dysarthric Speech | 6.75 (0 to 10) |
Collected over Adverse event data were collected for the entire study duration for each participant: baseline/assessment period, treatment period, and through 6 week post-treatment period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Combined Aphasia and Apraxia of Speech Treatment (CAAST) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Continuous(years) | Combined Aphasia and Apraxia of Speech Treatment (CAAST) |
|---|---|
| Mean | 51 (39 to 69) |
| Sex: Female, Male(Participants) | Combined Aphasia and Apraxia of Speech Treatment (CAAST) |
|---|---|
| Female | 2 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | Combined Aphasia and Apraxia of Speech Treatment (CAAST) |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Combined Aphasia and Apraxia of Speech Treatment (CAAST) |
|---|---|
| United States | 4 |
Plan to share: Undecided
Ran from Oct 2013 to primary completion in Dec 2016, 38 months.
Results were first posted in Jun 2019, 2 years 5 months after primary completion.
Of 30 interventional studies with no phase under Apraxias, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's 38 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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