- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01483807
Treatments of Acquired Apraxia of Speech (Apraxia)
December 17, 2018 updated by: VA Office of Research and Development
This study was designed to examine the effects of speech therapy on ability to produce speech sounds in persons with acquired apraxia of speech.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study was designed to investigate the effects of Sound Production Treatment (SPT; a treatment for acquired apraxia of speech) on sound production accuracy in persons with chronic apraxia of speech (AOS).
Organization of practice (blocked practice or randomized practice) will be manipulated in an effort to determine the most efficacious application of SPT.
A combination of group and single-subject experimental designs wasl be completed with 20 speakers with AOS (2 groups of 10 participants).
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84148
- VA Salt Lake City Health Care System, Salt Lake City, UT
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must have acquired apraxia of speech that occurred following a stroke or other brain injury.
- Must be at least 6 months post-onset of brain injury.
- May have aphasia.
Exclusion Criteria:
- History of drug or alcohol abuse.
- History of mental illness.
- Neurological condition other than that which resulted in apraxia of speech.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SPT-B then SPT-R
Participants first received Sound Production Treatment - Blocked (SPT-B) for 20 treatment sessions spanning approximately 7 weeks.
After a washout period of 2 weeks, they then received Sound Production Treatment - Random (SPT-R) for 20 treatment sessions.
Follow-up measures were conducted at 2, 6, and 10 weeks following the end of all treatment.
|
Sound Production Treatment is a treatment for acquired apraxia of speech.
Combines therapist modeling, simultaneous production, articulatory instruction, feedback and repeated practice.
SPT-Blocked entailed practicing all treatment targets blocked by target.
SPT-Random entailed practicing all treatment targets in a non predictable, random order.
A treatment for acquired apraxia of speech.
Combines therapist modeling, simultaneous production, articulatory instruction, feedback and repeated practice.
SPT-Random entailed practicing treatment targets in a non predictable order.
SPT-Blocked entailed practicing treatment targets blocked by target.
|
Experimental: SPT-R then SPT-B
Participants first received Sound Production Treatment - Random (SPT-R) for 20 treatment sessions spanning approximately 7 weeks.
After a washout period of 2 weeks, they then received Sound Production Treatment - Blocked (SPT-B) for 20 treatment sessions.
Follow-up measures were conducted at 2, 6, and 10 weeks following the end of all treatment.
|
Sound Production Treatment is a treatment for acquired apraxia of speech.
Combines therapist modeling, simultaneous production, articulatory instruction, feedback and repeated practice.
SPT-Blocked entailed practicing all treatment targets blocked by target.
SPT-Random entailed practicing all treatment targets in a non predictable, random order.
A treatment for acquired apraxia of speech.
Combines therapist modeling, simultaneous production, articulatory instruction, feedback and repeated practice.
SPT-Random entailed practicing treatment targets in a non predictable order.
SPT-Blocked entailed practicing treatment targets blocked by target.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech Production: Effect Size for Treated Items
Time Frame: Pre treatment (2-3 week period preceding the start of treatment) vs. 10 weeks post all treatment
|
Change in accuracy of articulation of trained items as measured from baseline to 10 weeks post treatment using effect size calculations as the indicator of magnitude of change; production of words designated for treatment was measured repeatedly in non treatment probes prior to treatment, throughout all study phases, and at 10 weeks post treatment with percent accuracy 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 (2-3 week period preceding the start of treatment) vs. 10 weeks post all treatment
|
Speech Production: Percent Change in Treated Items
Time Frame: baseline to 10 weeks post treatment
|
Change in accuracy of articulation of treated items as measured by percent increase in accuracy above the highest baseline measurement; production of words designated for treatment was measured repeatedly in non treatment probes prior to treatment, throughout all study phases, and at 10 weeks post treatment with percent accuracy calculated for each probe (0% to 100% correct).
The highest percentage accuracy achieved in pre-treatment probes was subtracted from the percentage accuracy achieved at 10 weeks post-treatment to obtain change in accuracy value - this reflects change from maximum correct performance in baseline (pre-treatment).
e.g., if in baseline probes, performance ranged from 10% to 30% accuracy and at post treatment performance was 90% accuracy, the change value would be 60% (90% minus 30%).
A greater change value indicates greater change in articulation/production of words.
Change could be positive (improved articulation) or negative (poorer articulation).
|
baseline to 10 weeks post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech Production: Percent Change in Untrained Items
Time Frame: baseline to 10 weeks post treatment
|
Percent change in articulatory accuracy of untrained items measured by change in percent accuracy over highest baseline value; production of words designated to NOT receive treatment (untrained items) was measured repeatedly in non treatment probes prior to treatment, throughout all study phases, and at 10 weeks post treatment with percent accuracy 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.
|
baseline to 10 weeks post treatment
|
Speech Production of Untrained Items: Effect Sizes for Untrained Items
Time Frame: Baseline vs. 10 weeks post all treatment
|
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 10 weeks post treatment with percent accuracy calculated for each probe (0% to 100% correct).
Change in accuracy of articulation of untrained items was measured from baseline to 10 weeks post treatment using effect size calculations as the indicator of magnitude of change.
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.
|
Baseline vs. 10 weeks post all treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Julie L Wambaugh, PhD, VA Salt Lake City Health Care System, Salt Lake City, UT
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wambaugh JL, Nessler C, Cameron R, Mauszycki SC. Treatment for acquired apraxia of speech: examination of treatment intensity and practice schedule. Am J Speech Lang Pathol. 2013 Feb;22(1):84-102. doi: 10.1044/1058-0360(2012/12-0025). Epub 2012 Oct 15.
- Wambaugh J, Shuster L, Bailey DJ, Mauszycki S, Kean J, Nessler C, Wright S, Brunsvold J. Self-Judgments of Word Production Accuracy in Acquired Apraxia of Speech. Am J Speech Lang Pathol. 2016 Dec 1;25(4S):S716-S728. doi: 10.1044/2016_AJSLP-15-0139.
- Bailey DJ, Eatchel K, Wambaugh J. Sound Production Treatment: Synthesis and Quantification of Outcomes. Am J Speech Lang Pathol. 2015 Nov;24(4):S798-814. doi: 10.1044/2015_AJSLP-14-0127.
- Wambaugh JL, Nessler C, Wright S, Mauszycki SC, DeLong C, Berggren K, Bailey DJ. Effects of Blocked and Random Practice Schedule on Outcomes of Sound Production Treatment for Acquired Apraxia of Speech: Results of a Group Investigation. J Speech Lang Hear Res. 2017 Jun 22;60(6S):1739-1751. doi: 10.1044/2017_JSLHR-S-16-0249.
- Mauszycki SC, Bailey DJ, Wambaugh JL. Acquired Apraxia of Speech: The Relationship Between Awareness of Errors in Word Productions and Treatment Outcomes. Am J Speech Lang Pathol. 2017 Jun 22;26(2S):664-673. doi: 10.1044/2017_AJSLP-16-0111.
- Wambaugh J, Nessler C, Wright S, Mauszycki S, DeLong C. Sound production treatment for acquired apraxia of speech: Effects of blocked and random practice on multisyllabic word production. Int J Speech Lang Pathol. 2016 Oct;18(5):450-64. doi: 10.3109/17549507.2015.1101161. Epub 2015 Nov 9. Erratum In: Int J Speech Lang Pathol. 2016 Oct;18(5):i.
- Wambaugh JL, Nessler C, Wright S, Mauszycki SC. Sound production treatment: effects of blocked and random practice. Am J Speech Lang Pathol. 2014 May;23(2):S225-45. doi: 10.1044/2014_AJSLP-13-0072.
- DeLong C, Nessler C, Wright S, Wambaugh J. Semantic Feature Analysis: Further Examination of Outcomes. Am J Speech Lang Pathol. 2015 Nov;24(4):S864-79. doi: 10.1044/2015_AJSLP-14-0155.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2011
Primary Completion (Actual)
September 30, 2017
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
April 15, 2011
First Submitted That Met QC Criteria
November 29, 2011
First Posted (Estimate)
December 1, 2011
Study Record Updates
Last Update Posted (Actual)
March 22, 2019
Last Update Submitted That Met QC Criteria
December 17, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C7419-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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