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A growing neurorehabilitation literature suggests that intense treatment may be desired to maximize the effects of therapy following neurologic injury. This investigation is designed to facilitate the development of efficacious, clinically applicable treatment for acquired apraxia of speech by examining the effects of intensity of treatment (e.g., 9 hours per week vs. 3 hours per week, while holding total number of sessions constant) with a group of speakers who have chronic apraxia of speech and aphasia.
This research was designed to examine the effects of treatment intensity on outcomes associated with an established treatment for acquired apraxia of speech (AOS). Intensity in the form of dose frequency and total intervention duration was evaluated with Sound Production Treatment (SPT). The investigators examined the effects of intense dose frequency (nine, one-hour sessions per week) and traditional dose frequency (three, one hour sessions per week). Total number of treatment sessions was held constant allowing for comparison of total intervention duration (27 sessions over 3 weeks versus 27 sessions over 9 weeks). A two-phase, group cross-over design was used. Thirty-six participants with chronic aphasia and AOS were recruited. Twenty-four participants completed then entire study and were quasi-randomly assigned to one of two treatment groups - intense first or traditional first (12 per group). One group received SPT applied with intense dose frequency (SPT-I) followed by SPT applied with traditional dose frequency (SPT-T). The other group received the treatments in the reverse order (SPT-T followed by SPT-I). A two week no treatment interval separated the treatment phases. The outcomes of interest addressed changes in trained and untrained speech behaviors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPT - Intense First | Experimental | Participants will receive intense application in the first phase of treatment, followed by the non intense application of treatment. |
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| SPT - Traditional First | Experimental | Participants will receive non intense, "traditional" application of treatment in the first phase of treatment, followed by the intense application of treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sound Production Treatment (SPT) | Behavioral | SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Articulation of TREATED ITEMS Measured as Effect Size - Change From Baseline to End of Treatment Phase | Accuracy of articulation of sounds in words, phrases, sentences designated for treatment. Assessed in nontreatment probes with productions elicited through repetition. Change in accuracy of articulation of trained items was measured from baseline to 2 weeks post treatment using effect size calculations as the indicator of magnitude of change. Percent accuracy was calculated for each probe (maximum = 100%, minimum = 0% correct). Effect size calculations involved calculating the difference between post- and pre-treatment probe accuracy percentages with corrections made for variability (standard deviations in performance). The larger the effect size, the greater the change in performance from pre-treatment. Positive effect sizes = increases in accuracy & negative effect sizes = decreases in accuracy. | Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase |
| Accuracy of Articulation of Untreated Items (Generalization) Measured as Effect Size - Change From Baseline to End of Treatment Phase | Change in accuracy of articulation of untrained items as measured by effect sizes reflecting magnitude of change. Production of words designated to not receive treatment (i.e., generalization items) was measured repeatedly in non treatment probes prior to treatment, throughout all study phases, and at 2 weeks post treatment with percent accuracy calculated for each probe (0% to 100% correct). Effect size calculations involved calculating the difference between post- and pre-treatment probe accuracy percentages with corrections made for variability (standard deviations in performance). The larger the effect size, the greater the change in performance from pre-treatment. | Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases | Measure of how well an unfamiliar listener can understand speech. The Assessment of Intelligibility of Dysarthric Speech will be employed. The participant will repeat words which will be audiorecorded. A trained, but unfamiliar listener will orthographically transcribe the words that are produced. The transcriptions will be compared to the list of target (intended words) to determine a percentage of words that are correctly understood. The score may range from 0% to 100% of words understood. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie L Wambaugh, PhD | VA Salt Lake City Health Care System, Salt Lake City, UT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania | 15240 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29497746 | Result | Wambaugh JL, Wright S, Boss E, Mauszycki SC, DeLong C, Hula W, Doyle PJ. Effects of Treatment Intensity on Outcomes in Acquired Apraxia of Speech. Am J Speech Lang Pathol. 2018 Mar 1;27(1S):306-322. doi: 10.1044/2017_AJSLP-16-0188. | |
| 32011909 | Result | Wambaugh JL, Wright S, Nessler C, Mauszycki SC, Bunker L, Boss E, Zhang Y, Hula WD, Doyle PJ. Further Study of the Effects of Treatment Intensity on Outcomes of Sound Production Treatment for Acquired Apraxia of Speech: Does Dose Frequency Matter? Am J Speech Lang Pathol. 2020 Feb 7;29(1):263-285. doi: 10.1044/2019_AJSLP-19-00005. Epub 2020 Feb 3. |
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All of the following will be shared for de-identified participants: Individual participant experimental stimuli will be provided in publications. Individual participant probe performance data will be shared in publications. Individual effect size data will be shared in publications. Individual pretreatment assessment performance will be shared in publications.
Individual data for 17 participants has been shared in publications. The data for the remaining 7 participants will be shared in a final publication - approximately by January 2022.
Individual data are available in publications.
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| ID | Title | Description |
|---|---|---|
| FG000 | SPT - Intense First | Participants will receive intense application in the first phase of treatment, followed by the non intense application of treatment. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy. |
| FG001 | SPT - Traditional First | Participants will receive non intense, "traditional" application of treatment in the first phase of treatment, followed by the intense application of treatment. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Persons with aphasia and apraxia of speech who completed both phases of treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | SPT - Intense First | Participants received intense application in the first phase of treatment, followed by the non intense application of treatment. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy. Intense application = SPT-I: treatment administered for 3 hourly sessions per day, 3 days per week, for 3 weeks for a total of 27 hourly sessions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of participants in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accuracy of Articulation of TREATED ITEMS Measured as Effect Size - Change From Baseline to End of Treatment Phase | Accuracy of articulation of sounds in words, phrases, sentences designated for treatment. Assessed in nontreatment probes with productions elicited through repetition. Change in accuracy of articulation of trained items was measured from baseline to 2 weeks post treatment using effect size calculations as the indicator of magnitude of change. Percent accuracy was calculated for each probe (maximum = 100%, minimum = 0% correct). Effect size calculations involved calculating the difference between post- and pre-treatment probe accuracy percentages with corrections made for variability (standard deviations in performance). The larger the effect size, the greater the change in performance from pre-treatment. Positive effect sizes = increases in accuracy & negative effect sizes = decreases in accuracy. | Posted | Mean | Standard Deviation | effect sizes; magnitude of change | Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase |
|
Entire course of study which was approximately 26 weeks per participant: pretreatment/baseline period = 4 weeks + 3 weeks Treatment 1 + 2 weeks washout + 9 weeks Treatment 2 + follow-up at 2 and 8 weeks.
All participants received two applications of SPT: intense application and non-intense (Traditional) application. Participants were grouped together for analyses by treatment type; this was due to the fact that all participants received both treatments and were observed in the same way for both treatments regardless of which treatment was received first. There were not adverse events and consequently, no need to examine adverse events by arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SPT - Intense: All Participants | All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in an intense manner (SPT-Intense; SPT-I) first for 27 sessions. Following a 2 week washout period, those participants then received SPT applied in non-intense fashion (SPT-Traditional; SPT-T) for 27 sessions. The other half of the participants received the treatments in the opposite order. All 24 administrations of SPT-Intense were analyzed relative to all 24 administrations of SPT-Traditional. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Wambaugh | University of Utah | 8015846164 | julie.wambaugh@health.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 3, 2020 | Oct 3, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 3, 2020 | Oct 3, 2020 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| D001072 | Apraxias |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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|
| Pre treatment & 2 weeks following each treatment phase |
| VA Salt Lake City Health Care System, Salt Lake City, UT |
| Salt Lake City |
| Utah |
| 84148 |
| United States |
| Travel distance prohibitive |
|
| did not meet inclusion criteria |
|
| BG001 | SPT - Traditional First | Participants received non intense, "traditional" application of treatment in the first phase of treatment, followed by the intense application of treatment. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy. Traditional application = SPT-T: treatment administered for 1 hourly session, 3 days per week for 9 weeks for a total of 27 hourly sessions. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Accuracy of Articulation of Treated Items in Baseline (Pre-treatment) | Accuracy of articulation of items designated for treatment. Experimental words were produced in pre-treatment probes. Participant productions were scored as being correctly produced according to phonetic transcription. The baseline measure represents the percentage of words produced correctly on a scale ranging from 0% accuracy to 100% accuracy. | Mean | Standard Deviation | units on a scale |
|
| Accuracy of Articulation of UNtreated Items in Baseline (Pre-treatment) | Accuracy of articulation of items designated to not receive treatment; these items were phonetically similar to treated items. Experimental words were produced in pre-treatment probes. Participant productions were scored as being correctly produced according to phonetic transcription. The baseline measure represents the percentage of words produced correctly on a scale ranging from 0% accuracy to 100% accuracy. | Mean | Standard Deviation | units on a scale |
|
| OG000 |
| SPT - Intense: All Participants |
All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in an intense manner (SPT-Intense; SPT-I) first for 27 sessions. Following a 2 week washout period, those participants then received SPT applied in non-intense fashion (SPT-Traditional; SPT-T) for 27 sessions. The other half of the participants received the treatments in the opposite order. All 24 administrations of SPT-Intense were analyzed relative to all 24 administrations of SPT-Traditional. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy. |
| OG001 | SPT - Traditional (Non-intense): All Participants | All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in a non-intense manner (SPT- Traditional; SPT-T) first for 27 sessions. Following a 2 week washout period, those participants then received SPT applied in an intense fashion (SPT-Intense; SPT-I) for 27 sessions. The other half of the participants received the treatments in the opposite order. All 24 administrations of SPT-Intense were analyzed relative to all 24 administrations of SPT-Traditional. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy. |
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| Primary | Accuracy of Articulation of Untreated Items (Generalization) Measured as Effect Size - Change From Baseline to End of Treatment Phase | Change in accuracy of articulation of untrained items as measured by effect sizes reflecting magnitude of change. Production of words designated to not receive treatment (i.e., generalization items) was measured repeatedly in non treatment probes prior to treatment, throughout all study phases, and at 2 weeks post treatment with percent accuracy calculated for each probe (0% to 100% correct). Effect size calculations involved calculating the difference between post- and pre-treatment probe accuracy percentages with corrections made for variability (standard deviations in performance). The larger the effect size, the greater the change in performance from pre-treatment. | 24 effect sizes from all 24 participants | Posted | Mean | Standard Deviation | effect sizes; magnitude of change | Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase |
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| Secondary | Speech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases | Measure of how well an unfamiliar listener can understand speech. The Assessment of Intelligibility of Dysarthric Speech will be employed. The participant will repeat words which will be audiorecorded. A trained, but unfamiliar listener will orthographically transcribe the words that are produced. The transcriptions will be compared to the list of target (intended words) to determine a percentage of words that are correctly understood. The score may range from 0% to 100% of words understood. | Intense SPT First Arm: one participant's data was lost due to data storage problems & three participants moved out of the region after the first treatment phase; Non-intense SPT First Arm: one participant's data was lost due to data storage problems & one participant moved out of the region after the first treatment phase | Posted | Mean | Standard Deviation | % Intelligible words | Pre treatment & 2 weeks following each treatment phase |
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| EG001 | SPT - Traditional (Non-intense): All Participants | All participants received Sound Production Treatment (SPT). Half the participants received SPT applied in a non-intense manner (SPT- Traditional; SPT-T) first for 27 sessions. Following a 2 week washout period, those participants then received SPT applied in an intense fashion (SPT-Intense; SPT-I) for 27 sessions. The other half of the participants received the treatments in the opposite order. All 24 administrations of SPT-Intense were analyzed relative to all 24 administrations of SPT-Traditional. Sound Production Treatment (SPT): SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy. | 0 | 24 | 0 | 24 | 0 | 24 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011596 | Psychomotor Disorders |
| 2 weeks Post Treatment #1: % Intelligibility |
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| 2 weeks Post Treatment #2: % Intelligibility |
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