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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02332915
Other study ID # C1782-R
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2015
Est. completion date October 10, 2019

Study information

Verified date March 2022
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date October 10, 2019
Est. primary completion date October 10, 2019
Accepts healthy volunteers No
Gender All
Age group 21 Years to 90 Years
Eligibility Inclusion Criteria: - Veterans and non Veterans - Males or females - Stroke survivor who is at least 4 months post-stroke - Speaker of English since childhood - Ability to pass a pure-tone hearing screening (aided or unaided) - currently non-hospitalized - Age 21 to 90 years Exclusion Criteria: - neurological condition other than stroke - currently clinically depressed - history of speech/language problems prior to stroke - untreated psychopathology

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Pittsburgh Pennsylvania
United States VA Salt Lake City Health Care System, Salt Lake City, UT Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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 Sp — View Citation

Outcome

Type Measure Description Time frame Safety issue
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. Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase
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. Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase
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. Pre treatment & 2 weeks following each treatment phase
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