NCT01979159

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2017

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 19, 2019

Completed
Last Updated

June 19, 2019

Status Verified

March 1, 2019

Enrollment Period

3.2 years

First QC Date

October 23, 2013

Results QC Date

January 2, 2018

Last Update Submit

March 14, 2019

Conditions

Keywords

aphasiaapraxia of speechoutcomes

Outcome Measures

Primary Outcomes (2)

  • 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.

    Following completion of treatment at 6 weeks post

  • 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.

    baseline (prior to treatment) through follow-up at 6 weeks post treatment

Secondary Outcomes (1)

  • Changes in Speech Intelligibility on the Assessment of Intelligibility of Dysarthric Speech

    pre and post treatment - prior to the start of treatment and at 6 weeks following the completion of treatment

Study Arms (1)

Combined Aphasia-ApraxiaTreatment

EXPERIMENTAL

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

Behavioral: Combined Aphasia and Apraxia of Speech Treatment (CAAST)

Interventions

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.

Also known as: CAAST
Combined Aphasia-ApraxiaTreatment

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans or non Veterans with aphasia and apraxia of speech who reside in the Salt Lake City region (commutable),
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Salt Lake City, Utah, 84148, United States

Location

Related Publications (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

ApraxiasAphasia

Condition Hierarchy (Ancestors)

Psychomotor DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpeech DisordersLanguage DisordersCommunication Disorders

Results Point of Contact

Title
Dr. Julie Wambaugh
Organization
VA Salt Lake City Health Care System

Study Officials

  • Julie L Wambaugh, PhD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-case experimental design; multiple baseline design across behaviors and participants
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2013

First Posted

November 8, 2013

Study Start

October 21, 2013

Primary Completion

December 30, 2016

Study Completion

December 22, 2017

Last Updated

June 19, 2019

Results First Posted

June 19, 2019

Record last verified: 2019-03

Locations