NCT02332915

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

December 22, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 17, 2020

Completed
Last Updated

July 12, 2022

Status Verified

March 1, 2022

Enrollment Period

4.4 years

First QC Date

December 22, 2014

Results QC Date

October 23, 2020

Last Update Submit

March 17, 2022

Conditions

Keywords

apraxiaaphasiarehabilitationefficacyintensity

Outcome Measures

Primary Outcomes (2)

  • Accuracy of Articulation of TREATED ITEMS Measured as Effect Size - Change From Baseline to End of 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

    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 Outcomes (1)

  • Speech Intelligibility - Percent Intelligible Words Comparing Baseline to End of Treatment Phases

    Pre treatment & 2 weeks following each treatment phase

Study Arms (2)

SPT - Intense First

EXPERIMENTAL

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 - Traditional First

EXPERIMENTAL

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)

Interventions

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.

SPT - Intense FirstSPT - Traditional First

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148, United States

Location

Related Publications (2)

  • Wambaugh JL, Wright S, Boss E, Mauszycki SC, DeLong C, Hula W, Doyle PJ. Effects of Treatment Intensity on Outcomes in Acquired Apraxia of Speech. Am J Speech Lang Pathol. 2018 Mar 1;27(1S):306-322. doi: 10.1044/2017_AJSLP-16-0188.

  • Wambaugh JL, Wright S, Nessler C, Mauszycki SC, Bunker L, Boss E, Zhang Y, Hula WD, Doyle PJ. Further Study of the Effects of Treatment Intensity on Outcomes of Sound Production Treatment for Acquired Apraxia of Speech: Does Dose Frequency Matter? Am J Speech Lang Pathol. 2020 Feb 7;29(1):263-285. doi: 10.1044/2019_AJSLP-19-00005. Epub 2020 Feb 3.

MeSH Terms

Conditions

AphasiaApraxias

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPsychomotor Disorders

Results Point of Contact

Title
Julie Wambaugh
Organization
University of Utah

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
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2014

First Posted

January 7, 2015

Study Start

May 1, 2015

Primary Completion

October 10, 2019

Study Completion

October 10, 2019

Last Updated

July 12, 2022

Results First Posted

November 17, 2020

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
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.
Access Criteria
Individual data are available in publications.

Locations