An interventional study of Sound Production Treatment (SPT) in Aphasia, CVA and Apraxia of Speech, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-07-12.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
338 studies on the registry are indexed under Aphasia; 95 are open to participants now.
This study's enrollment of 36 is above the median of 30 across 298 interventional studies indexed under Aphasia.
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Exclusion Criteria:
Participants will receive intense application in the first phase of treatment, followed by the non intense application of treatment.
Behavioral: Sound Production Treatment (SPT)
Participants will receive non intense, "traditional" application of treatment in the first phase of treatment, followed by the intense application of treatment.
Behavioral: 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.
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.
Time frame: 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.
Time frame: Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase
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.
Time frame: Pre treatment & 2 weeks following each treatment phase
| Milestone | SPT - Intense First | SPT - Traditional First |
|---|---|---|
| Started | 18 | 18 |
| Completed | 12 | 12 |
| Not completed | 6 | 6 |
| Withdrew: Moved out of region | 3 | 0 |
| Withdrew: Unrelated illness | 1 | 1 |
| Withdrew: Travel distance prohibitive | 0 | 1 |
| Withdrew: Did not meet inclusion criteria | 2 | 4 |
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.
| effect sizes; magnitude of change | SPT - Intense: All Participants | SPT - Traditional (Non-intense): All Participants |
|---|---|---|
| Accuracy of Articulation of TREATED ITEMS Measured as Effect Size - Change From Baseline to End of Treatment Phase | 19.7 ± 12.6 | 28.9 ± 17.2 |
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.
| effect sizes; magnitude of change | SPT - Intense; All Participants | SPT - Traditional; All Participants |
|---|---|---|
| Accuracy of Articulation of Untreated Items (Generalization) Measured as Effect Size - Change From Baseline to End of Treatment Phase | 7.9 ± 5.6 | 8.1 ± 8.9 |
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.
| % Intelligible words | Intense SPT First | Non-Intense (Traditional) SPT First | Both Arms Combined: Intense First + Traditional First |
|---|---|---|---|
| Baseline % Intelligibility | 45.15 ± 33.9 | 46.15 ± 29.5 | 48.96 ± 31.92 |
| 2 weeks Post Treatment #1: % Intelligibility | 54.3 ± 37.2 | 61.5 ± 30.5 | 60.5 ± 33.1 |
| 2 weeks Post Treatment #2: % Intelligibility | 61.3 ± 34.9 | 68.7 ± 30.5 | 65 ± 32.2 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SPT - Intense: All Participants | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| SPT - Traditional (Non-intense): All Participants | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
Persons with aphasia and apraxia of speech who completed both phases of treatment.
| Age, Continuous(years) | SPT - Intense First | SPT - Traditional First | Total |
|---|---|---|---|
| Mean | 55.75 ± 13.07 | 61.83 ± 12.13 | 58.79 ± 12.72 |
| Sex: Female, Male(Participants) | SPT - Intense First | SPT - Traditional First | Total |
|---|---|---|---|
| Female | 2 | 5 | 7 |
| Male | 10 | 7 | 17 |
| Ethnicity (NIH/OMB)(Participants) | SPT - Intense First | SPT - Traditional First | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 12 | 11 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | SPT - Intense First | SPT - Traditional First | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 12 | 11 | 23 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Accuracy of Articulation of Treated Items in Baseline (Pre-treatment)(units on a scale) | SPT - Intense First | SPT - Traditional First | Total |
|---|---|---|---|
| Mean | 12.03 ± 6.14 | 10.5 ± 8.3 | 11.28 ± 7.19 |
| Accuracy of Articulation of UNtreated Items in Baseline (Pre-treatment)(units on a scale) | SPT - Intense First | SPT - Traditional First | Total |
|---|---|---|---|
| Mean | 14.07 ± 6.67 | 13.9 ± 9.98 | 13.99 ± 8.3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: 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.
Access criteria: Individual data are available in publications.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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