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A Novel Treatment for Aphasia and Apraxia of Speech : Measurement of Outcomes

Primary Purpose

Apraxia of Speech, Aphasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combined Aphasia and Apraxia of Speech Treatment (CAAST)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apraxia of Speech focused on measuring aphasia, apraxia of speech, outcomes

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Veterans or non Veterans with aphasia and apraxia of speech who reside in the Salt Lake City region (commutable),
  • 12 months or more post stroke or other focal brain injury, no other neurological conditions,
  • native English speakers, hearing adequate for experimental task (e.g., pass puretone screening at 35dB at 500, 1K, 2K Hz),
  • non linguistic cognition within normal limits

Exclusion Criteria:

  • less than 12 months post stroke,
  • insufficient hearing, insufficient non linguistic cognitive skills,
  • neurological conditions other than stroke,
  • more than one stroke or brain injury
  • unable to attend treatment in the Salt Lake City vicinity

Sites / Locations

  • VA Salt Lake City Health Care System, Salt Lake City, UT

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined Aphasia-ApraxiaTreatment

Arm Description

Administration of Combined Aphasia and Apraxia of Speech Treatment )(CAAST) to 4 persons with aphasia and apraxia of speech in the context of single-subject designs

Outcomes

Primary Outcome Measures

Change in Language Content Production for Treated Stimuli: Effect Sizes (Magnitude of Change From Baseline to Follow-up)
Correct Information Units (CIUs) is a measure of the amount of relevant content produced in connected language tallied according to operationalized criteria. CIU is not a test or scale - it is a measure that is applied to language samples - in this case, description of treated pictures. Participants described experimental pictures, responses were transcribed and CIUs counted. CIUs can range from 0 to an unlimited maximum. Effect sizes (ESs) were calculated as an indication of the magnitude of change in number of CIUs produced (pre treatment to post treatment. ESs can range from negative (poorer performance post-treatment) to positive values (better performance post-treatment), with larger positive values reflecting greater gains. Benchmarks are as follows: >11.14 = large, 11.13 - 6.56 = medium, 6.55 - 3.88 = small, <3.88 = negligible. Small to large ESs indicate production of measurably more CIUs in picture descriptions post-treatment. Larger the ES, the greater the change.
Change in Production of Language Content for Untreated Sets - Generalization Measured in Effect Sizes
Correct Information Units (CIUs) is a measure of the amount of relevant content produced in connected language tallied according to operationalized criteria. CIU is not a test or scale - it is a measure that is applied to language samples - in this case, description of untreated pictures. Participants described experimental pictures, responses were transcribed and CIUs counted. CIUs can range from 0 to an unlimited maximum. Effect sizes (ESs) were calculated as an indication of the magnitude of change in number of CIUs produced (pre treatment to post treatment. ESs can range from negative (poorer performance post-treatment) to positive values (better performance post-treatment), with larger positive values reflecting greater gains. Benchmarks are as follows: >9.53 = large, 9.52 - 5.52 = medium, 6.55 - 3.29 = small, <3.29 = negligible. Small to large ESs indicate production of measurably more CIUs in picture descriptions post-treatment. Larger the ES, the greater the change.

Secondary Outcome Measures

Changes in Speech Intelligibility on the Assessment of Intelligibility of Dysarthric Speech
Speech intelligibility (understandability of speech) was measured by having participants produce 50 words from the Assessment of Intelligibility of Dysarthric Speech (ASSIDS) Two speech-language (blinded) scored pre and post treatment ASSIDS samples. The percentage of words correctly understood was calculated for each participant. The ASSIDS is not a scale - it is a procedure for calculating intelligibility. Speech intelligibility can range from 0% to 100% intelligible (no words understood to all words understood). The higher the percentage, the better the speech is understood by the listener. Change in percent words intelligible has the potential to be a negative (reflecting a poor outcome of less intelligible speech) or positive (reflecting a good outcome of more intelligible speech). The maximum possible amount of gain in intelligibility for these 4 participants, based on their pretreatment performance, ranged from +2% to +25%.

Full Information

First Posted
October 23, 2013
Last Updated
March 14, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01979159
Brief Title
A Novel Treatment for Aphasia and Apraxia of Speech : Measurement of Outcomes
Official Title
A Novel Treatment for Aphasia and Apraxia of Speech: Measurement of Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 21, 2013 (Actual)
Primary Completion Date
December 30, 2016 (Actual)
Study Completion Date
December 22, 2017 (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
In order to determine if speech-language therapy has positive effect, reliable measurement tools are required to document outcomes. Currently, there is very limited information concerning the measurement of changes in speech production as a result of treatment for acquired apraxia of speech and aphasia. This study will obtain information concerning the reliability of several speech production measures over time. Thirty persons with chronic aphasia and apraxia of speech will be asked to provide speech samples in response to commonly used assessment tools on three sampling occasions so that the stability of measurements may be examined. After establishment of appropriate outcome measures, a small, pilot treatment study will be conducted with four participants. The participants will receive a new treatment for aphasia and acquired apraxia of speech and outcomes will be measured relative to speech and language production.
Detailed Description
A single group, repeated measures design will be used to obtain repeated speech samples from 30 persons with chronic acquired apraxia of speech and aphasia. Speech samples will be elicited using commonly employed motor speech assessment protocols; an initial sample, a sample one week following the initial sample, and a sample at four weeks following the initial sample. The following measures will be obtained from the samples: percent consonants correct, percent fluent utterances, and duration of utterance. Stability of the measures will be examined. After the preceding measures have been analyzed, a series of four, single-subject experimental designs will be conducted. Four participants with chronic aphasia and apraxia of speech will receive a new treatment for aphasia and apraxia of speech applied sequentially to two sets of experimental picture picture stimuli. Outcomes will be measured in terms of speech production (measures described above) as well as in terms of language production.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apraxia of Speech, Aphasia
Keywords
aphasia, apraxia of speech, outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-case experimental design; multiple baseline design across behaviors and participants
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined Aphasia-ApraxiaTreatment
Arm Type
Experimental
Arm Description
Administration of Combined Aphasia and Apraxia of Speech Treatment )(CAAST) to 4 persons with aphasia and apraxia of speech in the context of single-subject designs
Intervention Type
Behavioral
Intervention Name(s)
Combined Aphasia and Apraxia of Speech Treatment (CAAST)
Other Intervention Name(s)
CAAST
Intervention Description
Therapy is delivered in a face-to-face format. The therapist uses picture stimuli, verbal modeling, feedback, reinforcement, forward-chaining to increase verbal production. For speech errors that occur, the therapist uses modeling, feedback, reinforcement, simultaneous production, articulatory instruction, and repeated practice to improve articulation.
Primary Outcome Measure Information:
Title
Change in Language Content Production for Treated Stimuli: Effect Sizes (Magnitude of Change From Baseline to Follow-up)
Description
Correct Information Units (CIUs) is a measure of the amount of relevant content produced in connected language tallied according to operationalized criteria. CIU is not a test or scale - it is a measure that is applied to language samples - in this case, description of treated pictures. Participants described experimental pictures, responses were transcribed and CIUs counted. CIUs can range from 0 to an unlimited maximum. Effect sizes (ESs) were calculated as an indication of the magnitude of change in number of CIUs produced (pre treatment to post treatment. ESs can range from negative (poorer performance post-treatment) to positive values (better performance post-treatment), with larger positive values reflecting greater gains. Benchmarks are as follows: >11.14 = large, 11.13 - 6.56 = medium, 6.55 - 3.88 = small, <3.88 = negligible. Small to large ESs indicate production of measurably more CIUs in picture descriptions post-treatment. Larger the ES, the greater the change.
Time Frame
Following completion of treatment at 6 weeks post
Title
Change in Production of Language Content for Untreated Sets - Generalization Measured in Effect Sizes
Description
Correct Information Units (CIUs) is a measure of the amount of relevant content produced in connected language tallied according to operationalized criteria. CIU is not a test or scale - it is a measure that is applied to language samples - in this case, description of untreated pictures. Participants described experimental pictures, responses were transcribed and CIUs counted. CIUs can range from 0 to an unlimited maximum. Effect sizes (ESs) were calculated as an indication of the magnitude of change in number of CIUs produced (pre treatment to post treatment. ESs can range from negative (poorer performance post-treatment) to positive values (better performance post-treatment), with larger positive values reflecting greater gains. Benchmarks are as follows: >9.53 = large, 9.52 - 5.52 = medium, 6.55 - 3.29 = small, <3.29 = negligible. Small to large ESs indicate production of measurably more CIUs in picture descriptions post-treatment. Larger the ES, the greater the change.
Time Frame
baseline (prior to treatment) through follow-up at 6 weeks post treatment
Secondary Outcome Measure Information:
Title
Changes in Speech Intelligibility on the Assessment of Intelligibility of Dysarthric Speech
Description
Speech intelligibility (understandability of speech) was measured by having participants produce 50 words from the Assessment of Intelligibility of Dysarthric Speech (ASSIDS) Two speech-language (blinded) scored pre and post treatment ASSIDS samples. The percentage of words correctly understood was calculated for each participant. The ASSIDS is not a scale - it is a procedure for calculating intelligibility. Speech intelligibility can range from 0% to 100% intelligible (no words understood to all words understood). The higher the percentage, the better the speech is understood by the listener. Change in percent words intelligible has the potential to be a negative (reflecting a poor outcome of less intelligible speech) or positive (reflecting a good outcome of more intelligible speech). The maximum possible amount of gain in intelligibility for these 4 participants, based on their pretreatment performance, ranged from +2% to +25%.
Time Frame
pre and post treatment - prior to the start of treatment and at 6 weeks following the completion of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans or non Veterans with aphasia and apraxia of speech who reside in the Salt Lake City region (commutable), 12 months or more post stroke or other focal brain injury, no other neurological conditions, native English speakers, hearing adequate for experimental task (e.g., pass puretone screening at 35dB at 500, 1K, 2K Hz), non linguistic cognition within normal limits Exclusion Criteria: less than 12 months post stroke, insufficient hearing, insufficient non linguistic cognitive skills, neurological conditions other than stroke, more than one stroke or brain injury unable to attend treatment in the Salt Lake City vicinity
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 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
Undecided
Citations:
PubMed Identifier
28084854
Citation
Wambaugh JL, Wright S, Mauszycki SC, Nessler C, Bailey D. Combined aphasia and apraxia of speech treatment (CAAST): Systematic replications in the development of a novel treatment. Int J Speech Lang Pathol. 2018 Apr;20(2):247-261. doi: 10.1080/17549507.2016.1267262. Epub 2017 Jan 13.
Results Reference
result
PubMed Identifier
25075917
Citation
Wambaugh JL, Wright S, Nessler C, Mauszycki SC. Combined Aphasia and Apraxia of Speech Treatment (CAAST): effects of a novel therapy. J Speech Lang Hear Res. 2014 Dec;57(6):2191-207. doi: 10.1044/2014_JSLHR-L-14-0004.
Results Reference
result
PubMed Identifier
28654945
Citation
Bailey DJ, Blomgren M, DeLong C, Berggren K, Wambaugh JL. Quantification and Systematic Characterization of Stuttering-Like Disfluencies in Acquired Apraxia of Speech. Am J Speech Lang Pathol. 2017 Jun 22;26(2S):641-648. doi: 10.1044/2017_AJSLP-16-0108.
Results Reference
result
PubMed Identifier
31072155
Citation
Haley KL, Smith M, Wambaugh JL. Sound Distortion Errors in Aphasia With Apraxia of Speech. Am J Speech Lang Pathol. 2019 Feb 21;28(1):121-135. doi: 10.1044/2018_AJSLP-17-0186.
Results Reference
derived
PubMed Identifier
30054623
Citation
Bunker LD, Nessler C, Wambaugh JL. Effect Size Benchmarks for Response Elaboration Training: A Meta-Analysis. Am J Speech Lang Pathol. 2019 Mar 11;28(1S):247-258. doi: 10.1044/2018_AJSLP-17-0152.
Results Reference
derived
PubMed Identifier
29497747
Citation
Bunker LD, Wright S, Wambaugh JL. Language Changes Following Combined Aphasia and Apraxia of Speech Treatment. Am J Speech Lang Pathol. 2018 Mar 1;27(1S):323-335. doi: 10.1044/2018_AJSLP-16-0193.
Results Reference
derived

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A Novel Treatment for Aphasia and Apraxia of Speech : Measurement of Outcomes

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