- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03645265
Rhythmic Entrainment in Bilingual Speakers With Dysarthria
The objectives of this study are to determine i) the effect of rhythmic entrainment of speech with hand gestures and auditory rhythmic cues on intelligibility and speech naturalness in Spanish-accented speakers of English in two pathology groups: ataxic dysarthria and hypokinetic dysarthria secondary to idiopathic Parkinson's disease; and ii) the extent to which speech rate and effort are control parameters of entrainment. These objectives will be achieved with the following specific aims:
Specific Aim 1: Determine the effect of three rates of hand gestures and auditory rhythmic cues and the degree to which learning and carry-over occur.
Specific Aim 2: Determine the effect of increased speech effort, operationalized as clear speech, and the interaction effect of clear speech with hand gestures and auditory rhythmic cues.
Specific Aim 3: Investigate the perception of speech rhythm and its relationship to entrainment.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objectives of this study are to determine i) the effect of rhythmic entrainment of speech with hand gestures and auditory rhythmic cues on intelligibility and speech naturalness in Spanish-accented speakers of English in two pathology groups: ataxic dysarthria and hypokinetic dysarthria secondary to idiopathic Parkinson's disease; and ii) the extent to which speech rate and effort are control parameters of entrainment. These objectives will be achieved with the following specific aims:
Specific Aim 1: Determine the effect of three rates of hand gestures and auditory rhythmic cues and the degree to which learning and carry-over occur.
Specific Aim 2: Determine the effect of increased speech effort, operationalized as clear speech, and the interaction effect of clear speech with hand gestures and auditory rhythmic cues.
Specific Aim 3: Investigate the perception of speech rhythm and its relationship to entrainment.
The protocol calls for 12 talkers to participate in a single case experimental design: 6 Spanish-accented speakers of English and 6 native English speakers, and each language group consisting of 2 healthy controls, 2 adults diagnosed with ataxic dysarthria and 2 adults diagnosed with hypokinetic dysarthria secondary to idiopathic Parkinson's disease. Sixty monolingual healthy adult listeners will rate intelligibility, accentedness, and ease of understanding.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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Bronx, New York, United States, 10468
- Lehman College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of idiopathic Parkinson's disease (4) or dysarthria secondary to ataxia (4) or healthy (4)
- monolingual speaker of American English (6) or native speaker of Spanish who speaks English with a Spanish accent (6)
- age 21 or older
Exclusion Criteria:
- Cognitive impairment that prevents participation in the therapy
- Fluent speakers of languages other than English or Spanish
- younger than 21 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Gestures
Use of hand gestures to improve speech rhythm and speech production
|
Use of gestures to improve speech production
|
EXPERIMENTAL: Auditory
Use of auditory cues to improve speech rhythm and speech production
|
Use of auditory cues to improve speech production
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intelligibility
Time Frame: immediately upon completion of the therapy
|
Intelligibility = the accuracy with which a listener understands a speaker.
It will be measured by having the subjects undergoing the therapy ("the talkers") read 28 phrases using accompanying gesture or auditory cues and listeners will transcribe the sentences.
The number of words accurately transcribed / the number of words in the phrase = intelligibility score for each phrase per listener
|
immediately upon completion of the therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ease of understanding
Time Frame: Immediately upon completion of the therapy
|
Ease of understanding = the ease with which listeners understand the speakers.
It will be measured by having the subjects undergoing the therapy ("the talkers") read 28 phrases using accompanying gesture or auditory cues and listeners will rate how easy it is to understand the talkers using a 0 to 9 visual analog scale with 0 = very easy and 9= very hard, for each phrase per listener
|
Immediately upon completion of the therapy
|
Speech naturalness
Time Frame: immediately upon completion of the therapy
|
Speech naturalness = the degree to which the listeners consider the speakers to have natural or unnatural speech.
It will be measured by having the subjects undergoing the therapy ("the talkers") read 28 phrases using accompanying gesture or auditory cues and listeners will rate how natural-sounding the talker sounds by using a 0 to 9 visual analog scale with 0 = very natural and 9 = very unnatural, for each phrase per listener
|
immediately upon completion of the therapy
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alison Behrman, PhD, Lehman College
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Language Disorders
- Communication Disorders
- Speech Disorders
- Articulation Disorders
- Parkinson Disease
- Dysarthria
Other Study ID Numbers
- 2017-0851
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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