NCT02554513

Brief Summary

The purpose of the proposed research is to examine the effects of two treatment approaches on speech production involving speakers with chronic apraxia of speech (AOS) and aphasia. The planned investigation is designed to examine the acquisition, maintenance and generalization effects of each treatment. One approach, electropalatography (EPG) uses visual biofeedback in conjunction with articulatory-kinematic treatment and the other approach, sound production treatment (SPT) is one of the most systematically studied articulatory-kinematic treatments for AOS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 2, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

November 4, 2021

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

Enrollment Period

3.3 years

First QC Date

August 19, 2015

Results QC Date

April 17, 2020

Last Update Submit

October 6, 2021

Conditions

Keywords

Apraxia of SpeechTreatment

Outcome Measures

Primary Outcomes (1)

  • Speech Production: Percent Change in Treated Items Immediately Post Treatment

    Change in accuracy of articulation of treated items 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 immediately post treatment with percent accuracy calculated for each probe (0% to 100% correct). The highest percentage accuracy achieved in baseline probes was subtracted from the percentage accuracy achieved at the conclusion of treatment to obtain change in accuracy value - this reflects change from maximum correct performance in baseline (baseline). 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 value indicates greater change in articulation/production of words. Change could be positive (improved articulation) or negative (poorer articulation)

    Baseline vs. Immediately Post Treatment (7 week treatment period)

Secondary Outcomes (4)

  • Speech Production: Percent Change in Untreated Items (Related Items) Immediately Post Treatment

    Baseline vs. Immediately Post Treatment (7 week treatment period)

  • Speech Production: Percent Change for Treated Items After the Completion of Treatment

    Baseline vs. 7 weeks post treatment [measured immediately after the completion of each treatment]

  • Functional Communication Skills: T-Score

    Baseline vs. 10 weeks after the completion of all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment]

  • Speech Intelligibility: Percentage

    Baseline vs. 10 weeks post all treatment [measured at pre-treatment and post-treatment; conclusion of all treatment]

Study Arms (2)

EPG Tx

ACTIVE COMPARATOR

An articulatory-kinematic treatment in conjunction with visual biofeedback specifically tongue to palate contact to improve speech production

Device: EPG Tx

Sound Production Treatment (SPT)

ACTIVE COMPARATOR

An articulatory-kinematic treatment that uses integral stimulation to improve speech production.

Behavioral: SPT

Interventions

EPG TxDEVICE

behavioral intervention that incorporates a device that provides visual biofeedback

Also known as: Electropalatography Treatment, Palatometer Treatment
EPG Tx
SPTBEHAVIORAL

A treatment hierarchy involving integral stimulation

Also known as: Sound Production Treatment
Sound Production Treatment (SPT)

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans or non Veterans with 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 or adequate aided hearing)
  • non linguistic cognition within normal limits

You may not qualify if:

  • less than 6 months post stroke
  • insufficient hearing, insufficient non linguistic cognitive skills
  • neurological conditions other than stroke
  • 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 (1)

  • Mauszycki SC, Wambaugh JL. Acquired Apraxia of Speech: Comparison of Electropalatography Treatment and Sound Production Treatment. Am J Speech Lang Pathol. 2020 Feb 21;29(1S):511-529. doi: 10.1044/2019_AJSLP-CAC48-18-0223. Epub 2019 Nov 6.

MeSH Terms

Conditions

ApraxiasAphasiaSpeech Disorders

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Shannon Mauszycki
Organization
VASLCHCS

Study Officials

  • Shannon C Mauszycki, 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
Masking Details
Single
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

August 19, 2015

First Posted

September 18, 2015

Study Start

November 2, 2015

Primary Completion

February 1, 2019

Study Completion

June 28, 2019

Last Updated

November 4, 2021

Results First Posted

November 4, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations