NCT01483807

Brief Summary

This study was designed to examine the effects of speech therapy on ability to produce speech sounds in persons with acquired apraxia of speech.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

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

First Submitted

Initial submission to the registry

April 15, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 22, 2019

Completed
Last Updated

March 22, 2019

Status Verified

December 1, 2018

Enrollment Period

6.2 years

First QC Date

April 15, 2011

Results QC Date

February 20, 2018

Last Update Submit

December 17, 2018

Conditions

Keywords

speechspeech therapyapraxia of speech

Outcome Measures

Primary Outcomes (2)

  • Speech Production: Effect Size for Treated Items

    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

    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 Outcomes (2)

  • Speech Production: Percent Change in Untrained Items

    baseline to 10 weeks post treatment

  • Speech Production of Untrained Items: Effect Sizes for Untrained Items

    Baseline vs. 10 weeks post all treatment

Study Arms (2)

SPT-B then SPT-R

EXPERIMENTAL

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.

Behavioral: Sound Production Treatment - BlockedBehavioral: Sound Production Treatment - Random

SPT-R then SPT-B

EXPERIMENTAL

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.

Behavioral: Sound Production Treatment - BlockedBehavioral: Sound Production Treatment - Random

Interventions

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.

SPT-B then SPT-RSPT-R then SPT-B

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.

SPT-B then SPT-RSPT-R then SPT-B

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • History of drug or alcohol abuse.
  • History of mental illness.
  • Neurological condition other than that which resulted in apraxia of speech.

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 (8)

  • 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.

  • 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.

MeSH Terms

Conditions

AphasiaApraxiasStrokeSpeechCommunication Disorders

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPsychomotor DisordersCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesVerbal BehaviorCommunicationBehaviorNeurodevelopmental DisordersMental Disorders

Limitations and Caveats

Two participants, one in each arm, received 10 sessions per phase rather than 20 sessions. This was due to these participants achieving high levels of accuracy very quickly; 20 sessions were not required (reduced burden).

Results Point of Contact

Title
Dr. Julie Wambaugh
Organization
VA SALT LAKE CITY HEALTHCARE 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
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Each participant received each arm of treatment
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2011

First Posted

December 1, 2011

Study Start

August 1, 2011

Primary Completion

September 30, 2017

Study Completion

December 31, 2017

Last Updated

March 22, 2019

Results First Posted

March 22, 2019

Record last verified: 2018-12

Locations