A Novel Treatment for Aphasia and Apraxia of Speech : Measurement of Outcomes
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Combined Aphasia-ApraxiaTreatment 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Language Content Production for Treated Stimuli: Effect Sizes (Magnitude of Change From Baseline to Follow-up) [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 [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.
Secondary Outcome Measures
- Changes in Speech Intelligibility on the Assessment of Intelligibility of Dysarthric Speech [pre and post treatment - prior to the start of treatment and at 6 weeks following the completion of treatment]
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%.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Salt Lake City Health Care System, Salt Lake City, UT | Salt Lake City | Utah | United States | 84148 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Julie L Wambaugh, PhD, VA Salt Lake City Health Care System, Salt Lake City, UT
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- O1356-P
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Combined Aphasia and Apraxia of Speech Treatment (CAAST) |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 4 |
| COMPLETED | 4 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Combined Aphasia and Apraxia of Speech Treatment (CAAST) |
|---|---|
| Arm/Group Description | Speakers with chronic aphasia and apraxia of speech who received the experimental treatment |
| Overall Participants | 4 |
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
51
|
| Sex: Female, Male (Count of Participants) | |
| Female |
2
50%
|
| Male |
2
50%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
1
25%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
3
75%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| United States |
4
100%
|
Outcome Measures
| Title | Change in Language Content Production for Treated Stimuli: Effect Sizes (Magnitude of Change From Baseline to Follow-up) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Combined Aphasia and Apraxia of Speech Treatment (CAAST) |
|---|---|
| Arm/Group Description | CAAST was administered to 4 persons with aphasia and apraxia of speech in the context of single-subject designs. |
| Measure Participants | 4 |
| Mean (Full Range) [units on a scale] |
13.38
|
| Title | Change in Production of Language Content for Untreated Sets - Generalization Measured in Effect Sizes |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| One participant received treatment on all sets; consequently, generalization to an untreated set could not be calculated |
| Arm/Group Title | Combined Aphasia and Apraxia of Speech Treatment (CAAST) |
|---|---|
| Arm/Group Description | CAAST was administered to 4 persons with aphasia and apraxia of speech in the context of single-subject designs |
| Measure Participants | 3 |
| Mean (Full Range) [units on a scale] |
7.99
|
| Title | Changes in Speech Intelligibility on the Assessment of Intelligibility of Dysarthric Speech |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Change in percent of words that were intelligible |
| Arm/Group Title | Combined Aphasia and Apraxia of Speech Treatment (CAAST) |
|---|---|
| Arm/Group Description | CAAST was administered to 4 persons with chronic aphasia and apraxia of speech in the context of single-subject designs |
| Measure Participants | 4 |
| Mean (Full Range) [percentage of change-intelligible words] |
6.75
|
Adverse Events
| Time Frame | 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. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Combined Aphasia and Apraxia of Speech Treatment (CAAST) | |
| Arm/Group Description | Administration of CAAST 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. | |
All Cause Mortality |
||
| Combined Aphasia and Apraxia of Speech Treatment (CAAST) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | |
Serious Adverse Events |
||
| Combined Aphasia and Apraxia of Speech Treatment (CAAST) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Combined Aphasia and Apraxia of Speech Treatment (CAAST) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Julie Wambaugh |
|---|---|
| Organization | VA Salt Lake City Health Care System |
| Phone | 801-582-1565 ext 1363 |
| julie.wambaugh@va.gov |
- O1356-P