Treatment Intensity - Apraxia of Speech
Primary Purpose
Aphasia, CVA, Apraxia of Speech
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sound Production Treatment (SPT)
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring apraxia, aphasia, rehabilitation, efficacy, intensity
Eligibility Criteria
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
Sites / Locations
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
- VA Salt Lake City Health Care System, Salt Lake City, UT
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SPT - Intense First
SPT - Traditional First
Arm Description
Participants will receive intense application in the first phase of treatment, followed by the non intense application of treatment.
Participants will receive non intense, "traditional" application of treatment in the first phase of treatment, followed by the intense application of treatment.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02332915
First Posted
December 22, 2014
Last Updated
March 17, 2022
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02332915
Brief Title
Treatment Intensity - Apraxia of Speech
Official Title
Effect of Intensity of Treatment on Rehabilitation of Acquired Apraxia of Speech
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, CVA, Apraxia of Speech
Keywords
apraxia, aphasia, rehabilitation, efficacy, intensity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPT - Intense First
Arm Type
Experimental
Arm Description
Participants will receive intense application in the first phase of treatment, followed by the non intense application of treatment.
Arm Title
SPT - Traditional First
Arm Type
Experimental
Arm Description
Participants will receive non intense, "traditional" application of treatment in the first phase of treatment, followed by the intense application of treatment.
Intervention Type
Behavioral
Intervention Name(s)
Sound Production Treatment (SPT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Accuracy of Articulation of TREATED ITEMS Measured as Effect Size - Change From Baseline to End of Treatment Phase
Description
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
Title
Accuracy of Articulation of Untreated Items (Generalization) Measured as Effect Size - Change From Baseline to End of Treatment Phase
Description
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
Secondary Outcome Measure Information:
Title
Speech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie L Wambaugh, PhD
Organizational Affiliation
VA Salt Lake City Health Care System, Salt Lake City, UT
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
VA Salt Lake City Health Care System, Salt Lake City, UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
Individual data are available in publications.
Citations:
PubMed Identifier
29497746
Citation
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.
Results Reference
result
PubMed Identifier
32011909
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 Speech Lang Pathol. 2020 Feb 7;29(1):263-285. doi: 10.1044/2019_AJSLP-19-00005. Epub 2020 Feb 3.
Results Reference
result
Learn more about this trial
Treatment Intensity - Apraxia of Speech
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