Apraxia of SpeechNCT01979159
A Novel Treatment for Aphasia and Apraxia of Speech : Measurement of Outcomes
A study testing Combined Aphasia and Apraxia of Speech Treatment (CAAST) in people with Apraxia of Speech and Aphasia, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Apraxia of Speech, Aphasia
- What is being tested?
- Combined Aphasia and Apraxia of Speech Treatment (CAAST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2013to 22 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans or non Veterans with aphasia and apraxia of speech who reside in the Salt Lake City region (commutable),
- 12 months or more post stroke or other focal brain injury, no other neurological conditions,
- native English speakers, hearing adequate for experimental task (e.g., pass puretone screening at 35dB at 500, 1K, 2K Hz),
- non linguistic cognition within normal limits
Who cannot join
- less than 12 months post stroke,
- insufficient hearing, insufficient non linguistic cognitive skills,
- neurological conditions other than stroke,
- more than one stroke or brain injury
- unable to attend treatment in the Salt Lake City vicinity
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148
About this study
Official title: A Novel Treatment for Aphasia and Apraxia of Speech: Measurement of Outcomes
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.
Read the detailed description
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.
- Conditions
- Apraxia of Speech, Aphasia
- Being tested
- Combined Aphasia and Apraxia of Speech Treatment (CAAST)
- Keywords
- aphasia, apraxia of speech, outcomes
- Medical subject headings
- Apraxias, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Aphasia and Apraxia of Speech Treatment (CAAST)Behavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Combined Aphasia-ApraxiaTreatment | Experimental | 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 Receives: Behavioral: Combined Aphasia and Apraxia of Speech Treatment (CAAST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline (prior to treatment) through follow-up at 6 weeks post treatment
Secondary outcomes (1)
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%.
Measured: pre and post treatment - prior to the start of treatment and at 6 weeks following the completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study start21 Oct 2013
- Primary completion30 Dec 2016
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Apraxia of SpeechStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-case experimental design; multiple baseline design across behaviors and participants
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Julie L Wambaugh, PhD, Principal investigator, VA Salt Lake City Health Care System, Salt Lake City, UT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979159
- Sponsor's protocol ID
- O1356-P
- Status last verified
- Mar 2019
- First submitted
- 23 Oct 2013
- Last updated
- 19 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wambaugh JL, Wright S, Mauszycki SC, Nessler C, Bailey D. Combined aphasia and apraxia of speech treatment (CAAST): Systematic replications in the development of a novel treatment. Int J Speech Lang Pathol. 2018 Apr;20(2):247-261. doi: 10.1080/17549507.2016.1267262. Epub 2017 Jan 13.
PubMed 28084854Wambaugh JL, Wright S, Nessler C, Mauszycki SC. Combined Aphasia and Apraxia of Speech Treatment (CAAST): effects of a novel therapy. J Speech Lang Hear Res. 2014 Dec;57(6):2191-207. doi: 10.1044/2014_JSLHR-L-14-0004.
PubMed 25075917Bailey DJ, Blomgren M, DeLong C, Berggren K, Wambaugh JL. Quantification and Systematic Characterization of Stuttering-Like Disfluencies in Acquired Apraxia of Speech. Am J Speech Lang Pathol. 2017 Jun 22;26(2S):641-648. doi: 10.1044/2017_AJSLP-16-0108.
PubMed 28654945Haley KL, Smith M, Wambaugh JL. Sound Distortion Errors in Aphasia With Apraxia of Speech. Am J Speech Lang Pathol. 2019 Feb 21;28(1):121-135. doi: 10.1044/2018_AJSLP-17-0186.
PubMed 31072155Bunker LD, Nessler C, Wambaugh JL. Effect Size Benchmarks for Response Elaboration Training: A Meta-Analysis. Am J Speech Lang Pathol. 2019 Mar 11;28(1S):247-258. doi: 10.1044/2018_AJSLP-17-0152.
PubMed 30054623Bunker LD, Wright S, Wambaugh JL. Language Changes Following Combined Aphasia and Apraxia of Speech Treatment. Am J Speech Lang Pathol. 2018 Mar 1;27(1S):323-335. doi: 10.1044/2018_AJSLP-16-0193.
PubMed 29497747
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Treatment for Aphasia and Apraxia of Speech: Measurement of Outcomes
- ClinicalTrials.gov ID
- NCT01979159
- Acronym / sponsor ID
- O1356-P
- Conditions
- Apraxia of Speech, Aphasia
- Keywords
- aphasia, apraxia of speech, outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 21 Oct 2013 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Posted 19 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-case experimental design; multiple baseline design across behaviors and participants
| Arm | Type | Receives |
|---|---|---|
| Combined Aphasia-ApraxiaTreatment | Experimental | Behavioral: Combined Aphasia and Apraxia of Speech Treatment (CAAST)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 |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Veterans or non Veterans with aphasia and apraxia of speech who reside in the Salt Lake City region (commutable),
- 12 months or more post stroke or other focal brain injury, no other neurological conditions,
- native English speakers, hearing adequate for experimental task (e.g., pass puretone screening at 35dB at 500, 1K, 2K Hz),
- non linguistic cognition within normal limits
Key exclusion criteria (5 listed)
- less than 12 months post stroke,
- insufficient hearing, insufficient non linguistic cognitive skills,
- neurological conditions other than stroke,
- more than one stroke or brain injury
- unable to attend treatment in the Salt Lake City vicinity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Aphasia and Apraxia of Speech Treatment (CAAST)Also: CAASTTherapy 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. | Behavioural | Combined Aphasia-ApraxiaTreatment |
Primary outcome
Change in Language Content Production for Treated Stimuli: Effect Sizes (Magnitude of Change From Baseline to Follow-up)
Time frame: Following completion of treatment at 6 weeks post
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.
Change in Production of Language Content for Untreated Sets - Generalization Measured in Effect Sizes
Time frame: baseline (prior to treatment) through follow-up at 6 weeks post treatment
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.
1 secondary outcome
Changes in Speech Intelligibility on the Assessment of Intelligibility of Dysarthric Speech
Time frame: pre and post treatment - prior to the start of treatment and at 6 weeks following the completion of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28084854Wambaugh JL, Wright S, Mauszycki SC, Nessler C, Bailey D. Combined aphasia and apraxia of speech treatment (CAAST): Systematic replications in the development of a novel treatment. Int J Speech Lang Pathol. 2018 Apr;20(2):247-261. doi: 10.1080/17549507.2016.1267262. Epub 2017 Jan 13.
- Results publication: PubMed 25075917Wambaugh JL, Wright S, Nessler C, Mauszycki SC. Combined Aphasia and Apraxia of Speech Treatment (CAAST): effects of a novel therapy. J Speech Lang Hear Res. 2014 Dec;57(6):2191-207. doi: 10.1044/2014_JSLHR-L-14-0004.
- Results publication: PubMed 28654945Bailey DJ, Blomgren M, DeLong C, Berggren K, Wambaugh JL. Quantification and Systematic Characterization of Stuttering-Like Disfluencies in Acquired Apraxia of Speech. Am J Speech Lang Pathol. 2017 Jun 22;26(2S):641-648. doi: 10.1044/2017_AJSLP-16-0108.
- Derived from this study: PubMed 31072155Haley KL, Smith M, Wambaugh JL. Sound Distortion Errors in Aphasia With Apraxia of Speech. Am J Speech Lang Pathol. 2019 Feb 21;28(1):121-135. doi: 10.1044/2018_AJSLP-17-0186.
- Derived from this study: PubMed 30054623Bunker LD, Nessler C, Wambaugh JL. Effect Size Benchmarks for Response Elaboration Training: A Meta-Analysis. Am J Speech Lang Pathol. 2019 Mar 11;28(1S):247-258. doi: 10.1044/2018_AJSLP-17-0152.
- Derived from this study: PubMed 29497747Bunker LD, Wright S, Wambaugh JL. Language Changes Following Combined Aphasia and Apraxia of Speech Treatment. Am J Speech Lang Pathol. 2018 Mar 1;27(1S):323-335. doi: 10.1044/2018_AJSLP-16-0193.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie L Wambaugh, PhD principal investigator
VA Salt Lake City Health Care System, Salt Lake City, UT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Aphasia and Apraxia of Speech Treatment (CAAST) in people with Apraxia of Speech and Aphasia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Language Content Production for Treated Stimuli: Effect Sizes (Magnitude of Change From Baseline to Follow-up) (time frame: Following completion of treatment at 6 weeks post). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01979159, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.