NCT04897711

Brief Summary

There exist very few effective treatments that ease the intelligibility burden of dysarthria. Perceptual training offers a promising avenue for improving intelligibility of dysarthric speech by offsetting the communicative burden from the speaker with dysarthria on to their primary communication partners-family, friends, and caregivers. This project, utilizing advanced explanatory models, will permit identification of speaker and listener parameters, and their interactions, that allow perceptual training paradigms to be optimized for intelligibility outcomes in dysarthria rehabilitation. This work addresses this critical gap in clinical practice and sets the stage for extension of dysarthria management to listener-targeted remediation-advancing clinical practice and enhanced communication and quality of life outcomes for this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration 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

Study Start

First participant enrolled

April 26, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.2 years

First QC Date

May 10, 2021

Results QC Date

July 11, 2024

Last Update Submit

September 6, 2024

Conditions

Keywords

dysarthriamotor speech disordersintelligibilityperceptual training

Outcome Measures

Primary Outcomes (2)

  • Pretest Transcription Accuracy

    A percentage words correct (PWC) score is tabulated for each listener at pretest. A higher score reflects greater speaker intelligibility (i.e., understanding).

    All outcomes were collected during a single data collection session, that lasted no more than 90 minutes. Pretest transcription accuracy is assessed at the pretest, immediately before a single session of perceptual training.

  • Posttest Transcription Accuracy

    A percentage words correct (PWC) score is tabulated for each listener at posttest. Higher scores reflect greater speaker intelligibility (i.e., understanding).

    All outcomes were collected during a single data collection session, lasting no longer than 90 minutes. Transcription accuracy at posttest was assessed at posttest, immediately after perceptual training.

Study Arms (5)

Perceptual training with a speaker with dysarthria - Amyotrophic Lateral Sclerosis (ALS)

EXPERIMENTAL

To examine the effect of perceptual training with different speakers with dysarthria, we use a standard three-phase perceptual training protocol involving pretest, training, and posttest phases. Speech samples from a single speaker with dysarthria are utilized for all three phases. In this arm, listener participants were assigned to Speaker 1 (mixed flaccid-spastic dysarthria due to amyotrophic lateral sclerosis)

Behavioral: Perceptual Training

Perceptual training with a speaker with dysarthria - Ataxic 1

EXPERIMENTAL

To examine the effect of perceptual training with different speakers with dysarthria, we use a standard three-phase perceptual training protocol involving pretest, training, and posttest phases. Speech samples from a single speaker with dysarthria are utilized for all three phases. In this arm, listener participants were assigned to Speaker 2 (Ataxic dysarthria due to cerebellar degeneration)

Behavioral: Perceptual Training

Perceptual training with a speaker with dysarthria - Parkinson's disease (PD) 1

EXPERIMENTAL

To examine the effect of perceptual training with different speakers with dysarthria, we use a standard three-phase perceptual training protocol involving pretest, training, and posttest phases. Speech samples from a single speaker with dysarthria are utilized for all three phases. In this arm, listener participants were assigned to Speaker 3 (hypokinetic dysarthria due to Parkinson's disease)

Behavioral: Perceptual Training

Perceptual training with a speaker with dysarthria - Ataxic 2

EXPERIMENTAL

To examine the effect of perceptual training with different speakers with dysarthria, we use a standard three-phase perceptual training protocol involving pretest, training, and posttest phases. Speech samples from a single speaker with dysarthria are utilized for all three phases. In this arm, listener participants were assigned to Speaker 4 (Ataxic dysarthria due to cerebellar degeneration)

Behavioral: Perceptual Training

Perceptual training with a speaker with dysarthria - Parkinson's disease (PD) 2

EXPERIMENTAL

To examine the effect of perceptual training with different speakers with dysarthria, we use a standard three-phase perceptual training protocol involving pretest, training, and posttest phases. Speech samples from a single speaker with dysarthria are utilized for all three phases. In this arm, listener participants were assigned to Speaker 5 (hypokinetic dysarthria due to Parkinson's disease)

Behavioral: Perceptual Training

Interventions

Each listener is familiarized/trained with a single speaker with dysarthria. Pretest/posttest transcription data will be used to build explanatory models of intelligibility improvement.

Also known as: Familiarization
Perceptual training with a speaker with dysarthria - Amyotrophic Lateral Sclerosis (ALS)Perceptual training with a speaker with dysarthria - Ataxic 1Perceptual training with a speaker with dysarthria - Ataxic 2Perceptual training with a speaker with dysarthria - Parkinson's disease (PD) 1Perceptual training with a speaker with dysarthria - Parkinson's disease (PD) 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \*Native speakers of American English

You may not qualify if:

  • No self-reported history of speech impairment
  • No self-reported history of language impairment
  • No self-reported history of cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Florida State University

Tallahassee, Florida, 32301, United States

Location

Utah State University

Logan, Utah, 84322, United States

Location

Related Publications (11)

  • Borrie SA, Lansford KL, Barrett TS. Understanding dysrhythmic speech: When rhythm does not matter and learning does not happen. J Acoust Soc Am. 2018 May;143(5):EL379. doi: 10.1121/1.5037620.

    PMID: 29857710BACKGROUND
  • Lansford KL, Borrie SA, Barrett TS. Regularity Matters: Unpredictable Speech Degradation Inhibits Adaptation to Dysarthric Speech. J Speech Lang Hear Res. 2019 Nov 20;62(12):4282-4290. doi: 10.1044/2019_JSLHR-19-00055. Print 2019 Dec 18.

    PMID: 31747531BACKGROUND
  • Borrie SA, Lansford KL, Barrett TS. Rhythm Perception and Its Role in Perception and Learning of Dysrhythmic Speech. J Speech Lang Hear Res. 2017 Mar 1;60(3):561-570. doi: 10.1044/2016_JSLHR-S-16-0094.

    PMID: 28241307BACKGROUND
  • Lansford KL, Borrie SA, Bystricky L. Use of Crowdsourcing to Assess the Ecological Validity of Perceptual-Training Paradigms in Dysarthria. Am J Speech Lang Pathol. 2016 May 1;25(2):233-9. doi: 10.1044/2015_AJSLP-15-0059.

    PMID: 27145295BACKGROUND
  • Borrie SA, McAuliffe MJ, Liss JM, Kirk C, O'Beirne GA, Anderson T. Familiarisation conditions and the mechanisms that underlie improved recognition of dysarthric speech. Lang Cogn Process. 2012 Sep 1;27(7-8):1039-1055. doi: 10.1080/01690965.2011.610596.

    PMID: 24009401BACKGROUND
  • Borrie SA, Lansford KL, Barrett TS. Generalized Adaptation to Dysarthric Speech. J Speech Lang Hear Res. 2017 Nov 9;60(11):3110-3117. doi: 10.1044/2017_JSLHR-S-17-0127.

    PMID: 29075754BACKGROUND
  • Lansford KL, Luhrsen S, Ingvalson EM, Borrie SA. Effects of Familiarization on Intelligibility of Dysarthric Speech in Older Adults With and Without Hearing Loss. Am J Speech Lang Pathol. 2018 Feb 6;27(1):91-98. doi: 10.1044/2017_AJSLP-17-0090.

    PMID: 29305612BACKGROUND
  • Hirsch ME, Lansford KL, Barrett TS, Borrie SA. Generalized Learning of Dysarthric Speech Between Male and Female Talkers. J Speech Lang Hear Res. 2021 Feb 17;64(2):444-451. doi: 10.1044/2020_JSLHR-20-00313. Epub 2021 Jan 28.

    PMID: 33508210BACKGROUND
  • Lansford KL, Borrie SA, Barrett TS, Flechaus C. When Additional Training Isn't Enough: Further Evidence That Unpredictable Speech Inhibits Adaptation. J Speech Lang Hear Res. 2020 Jun 22;63(6):1700-1711. doi: 10.1044/2020_JSLHR-19-00380. Epub 2020 May 20.

    PMID: 32437259BACKGROUND
  • Borrie SA, Lansford KL, Barrett TS. A Clinical Advantage: Experience Informs Recognition and Adaptation to a Novel Talker With Dysarthria. J Speech Lang Hear Res. 2021 May 11;64(5):1503-1514. doi: 10.1044/2021_JSLHR-20-00663. Epub 2021 Apr 8.

    PMID: 33831307BACKGROUND
  • Borrie SA, Barrett TS, Yoho SE. Autoscore: An open-source automated tool for scoring listener perception of speech. J Acoust Soc Am. 2019 Jan;145(1):392. doi: 10.1121/1.5087276.

    PMID: 30710955BACKGROUND

MeSH Terms

Conditions

DysarthriaSpeech Intelligibility

Condition Hierarchy (Ancestors)

Articulation DisordersSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpeechVerbal BehaviorCommunicationBehavior

Limitations and Caveats

While classified as a clinical trial, the aims of this study were to build explanatory models of perceptual learning of dysarthric speech. All participants received perceptual training with one of 5 speakers with dysarthria. The focus of this work was not to establish the efficacy of perceptual training but rather to identify individual listener variables that support perceptual learning. As such, all models were built on individual participant data.

Results Point of Contact

Title
Stephanie Borrie
Organization
Utah State University

Study Officials

  • Stephanie A Borrie, PhD

    Utah State University

    PRINCIPAL INVESTIGATOR
  • Kaitlin L Lansford, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 300 listeners will be recruited and enrolled. Each participant will be randomly assigned to receive perceptual training with one of 5 speakers with dysarthria, such that 30-50 listeners will be assigned to each speaker with dysarthria. All listener participants will receive the perceptual training intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 21, 2021

Study Start

April 26, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Results of the proposed research will be disseminated through conference presentations and manuscripts submitted to academic journals. In addition, the de-identified data will be available for public access via a data repository at the University of Michigan (ICPSR). The study will be registered in ClinicalTrials.gov within 21 days of enrollment of the first participant. Results will be submitted within 1 year of completion of the study. Informed consent documents will contain a statement concerning posting of information to ClinicalTrials.gov. Utah State University's Investigator Handbook (Chapter 9) outlines a policy for reporting all ClinicalTrials.gov information, specifically stating that it is the PI's responsibility to do so according to NIH policy.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Within one year of completion
Access Criteria
Information related to the protocol and statistical analysis plan will be shared in future publications. The analytic code will be shared via the Open Science website, with the link included in associated publications.

Locations