Treatment Intensity - Apraxia of Speech

March 17, 2022 updated by: VA Office of Research and Development

Effect of Intensity of Treatment on Rehabilitation of Acquired Apraxia of Speech

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This research was 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 was evaluated with Sound Production Treatment (SPT). The investigators examined 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 was 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 was used. Thirty-six participants with chronic aphasia and AOS were recruited. Twenty-four participants completed then entire study and were quasi-randomly assigned to one of two treatment groups - intense first or traditional first (12 per group). One group received SPT applied with intense dose frequency (SPT-I) followed by SPT applied with traditional dose frequency (SPT-T). The other group received the treatments in the reverse order (SPT-T followed by SPT-I). A two week no treatment interval separated the treatment phases. The outcomes of interest addressed changes in trained and untrained speech behaviors.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • VA Salt Lake City Health Care System, Salt Lake City, UT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Veterans and non Veterans
  • Males or females
  • Stroke survivor who is at least 4 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. Change in accuracy of articulation of trained items was measured from baseline to 2 weeks post treatment using effect size calculations as the indicator of magnitude of change. Percent accuracy was 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 weeks following the first treatment phase, 2 weeks following the second treatment phase
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
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 2 weeks post treatment with percent accuracy calculated for each probe (0% to 100% 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.
Pre treatment, 2 weeks following the first treatment phase, 2 weeks following the second treatment phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases
Time Frame: Pre treatment & 2 weeks following each 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. The score may range from 0% to 100% of words understood.
Pre treatment & 2 weeks following each treatment phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Julie L Wambaugh, PhD, VA Salt Lake City Health Care System, Salt Lake City, UT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

October 10, 2019

Study Completion (Actual)

October 10, 2019

Study Registration Dates

First Submitted

December 22, 2014

First Submitted That Met QC Criteria

January 5, 2015

First Posted (Estimate)

January 7, 2015

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1782-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Time Frame

Individual data for 17 participants has been shared in publications. The data for the remaining 7 participants will be shared in a final publication - approximately by January 2022.

IPD Sharing Access Criteria

Individual data are available in publications.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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