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Trial record 10 of 27 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Utah, United States ) | NIH, U.S. Fed

Treatment Intensity - Apraxia of Speech

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ClinicalTrials.gov Identifier: NCT02332915
Recruitment Status : Recruiting
First Posted : January 7, 2015
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
A growing neurorehabilitation literature suggests that intense treatment may be desired to maximize the effects of therapy following neurologic injury. This investigation is designed to facilitate the development of efficacious, clinically applicable treatment for acquired apraxia of speech by examining the effects of intensity of treatment (e.g., 9 hours per week vs. 3 hours per week, while holding total number of sessions constant) with a group of speakers who have chronic apraxia of speech and aphasia.

Condition or disease Intervention/treatment Phase
Aphasia CVA Apraxia of Speech Behavioral: Sound Production Treatment (SPT) Not Applicable

Detailed Description:
This research is designed to examine the effects of treatment intensity on outcomes associated with an established treatment for acquired apraxia of speech (AOS). Intensity in the form of dose frequency and total intervention duration will be evaluated with Sound Production Treatment (SPT). The investigators will examine the effects of intense dose frequency (nine, one-hour sessions per week) and traditional dose frequency (three, one hour sessions per week). Total number of treatment sessions will be held constant allowing for comparison of total intervention duration (27 sessions over 3 weeks versus 27 sessions over 9 weeks). A two-phase, group cross-over design will be used. Thirty-six participants with chronic aphasia and AOS will be quasi-randomly assigned to one of two treatment groups - intense first or traditional first (18 per group). One group will receive SPT applied with intense dose frequency (SPT-I) followed by SPT applied with traditional dose frequency (SPT-T). The other group will receive the treatments in the reverse order (SPT-T followed by SPT-I). A two week no treatment interval will separate the treatment phases. The outcomes of interest will address changes in trained speech behaviors, untrained speech behaviors, and speech intelligibility and patient-rated communicative functioning.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intensity of Treatment on Rehabilitation of Acquired Apraxia of Speech
Actual Study Start Date : May 1, 2015
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: SPT - Intense First
Participants will receive intense application in the first phase of treatment, followed by the non intense application of treatment.
Behavioral: Sound Production Treatment (SPT)
SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy.

Experimental: SPT - Traditional First
Participants will receive non intense, "traditional" application of treatment in the first phase of treatment, followed by the intense application of treatment.
Behavioral: Sound Production Treatment (SPT)
SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy.




Primary Outcome Measures :
  1. Accuracy of articulation of treated items measured as effect size - change from baseline to end of treatment phase [ Time Frame: Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase ]
    Accuracy of articulation of sounds in words, phrases, sentences designated for treatment. Assessed in nontreatment probes with productions elicited through repetition.

  2. Accuracy of articulation of untreated items (generalization) measured as effect size - change from baseline to end of treatment phase [ Time Frame: Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase ]
    Accuracy of articulation of sounds in words, phrases, and/or sentences that are untreated (but, are similar to treated items). Assessed in nontreatment probes with productions elicited through repetition.


Secondary Outcome Measures :
  1. Speech Intelligibility - change scores comparing baseline to end of treatment phases [ Time Frame: Pre treatment & 2 weeks following the first treatment phase & 2 weeks following the second treatment phase ]
    Measure of how well an unfamiliar listener can understand speech. The Assessment of Intelligibility of Dysarthric Speech will be employed. The participant will repeat words which will be audiorecorded. A trained, but unfamiliar listener will orthographically transcribe the words that are produced. The transcriptions will be compared to the list of target (intended words) to determine a percentage of words that are correctly understood.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans and non Veterans
  • Males or females
  • Stroke survivor who is at least 6 months post-stroke
  • Speaker of English since childhood
  • Ability to pass a pure-tone hearing screening (aided or unaided)
  • currently non-hospitalized
  • Age 21 to 90 years

Exclusion Criteria:

  • neurological condition other than stroke
  • currently clinically depressed
  • history of speech/language problems prior to stroke
  • untreated psychopathology

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): NCT02332915


Contacts
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Contact: Julie L Wambaugh, PhD (801) 582-1565 Julie.Wambaugh@va.gov
Contact: Shannon C Mauszycki, PhD (801) 582-1565 ext 2182 shannon.mauszycki@va.gov

Locations
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United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Patrick J Doyle, PhD    412-360-6427    patrick.doyle@va.gov   
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Julie L Wambaugh, PhD    801-582-1565    Julie.Wambaugh@va.gov   
Principal Investigator: Julie L Wambaugh, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Julie L Wambaugh, PhD VA Salt Lake City Health Care System, Salt Lake City, UT

Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02332915     History of Changes
Other Study ID Numbers: C1782-R
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the following will be shared for de-identified participants: Individual participant experimental stimuli will be provided in publications. Individual participant probe performance data will be shared in publications. Individual effect size data will be shared in publications. Individual pretreatment assessment performance will be shared in publications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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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:
apraxia
aphasia
rehabilitation
efficacy
intensity

Additional relevant MeSH terms:
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Aphasia
Apraxias
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Psychomotor Disorders