Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatments of Acquired Apraxia of Speech (Apraxia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01483807
Recruitment Status : Completed
First Posted : December 1, 2011
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Aphasia Apraxia of Speech Stroke Behavioral: Sound Production Treatment - Blocked Behavioral: Sound Production Treatment - Random Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Each participant received each arm of treatment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatments of Acquired Apraxia of Speech
Actual Study Start Date : August 1, 2011
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


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.
Behavioral: Sound Production Treatment - Blocked
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.

Behavioral: Sound Production Treatment - Random
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.
Behavioral: Sound Production Treatment - Blocked
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.

Behavioral: Sound Production Treatment - Random
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.




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483807


Locations
Layout table for location information
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Julie L Wambaugh, PhD VA Salt Lake City Health Care System, Salt Lake City, UT
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Study Protocol  [PDF] November 22, 2015
Informed Consent Form  [PDF] November 22, 2015
Statistical Analysis Plan  [PDF] November 22, 2015


Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01483807     History of Changes
Other Study ID Numbers: C7419-R
First Posted: December 1, 2011    Key Record Dates
Results First Posted: March 22, 2019
Last Update Posted: March 22, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
Keywords provided by VA Office of Research and Development:
speech
speech therapy
apraxia of speech
Additional relevant MeSH terms:
Layout table for MeSH terms
Aphasia
Apraxias
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Psychomotor Disorders