ClinicalTrials.gg
TerminatedNCT03645265Updated Feb 26, 2019

Rhythmic Entrainment in Bilingual Speakers With Dysarthria

An interventional study of Auditory and Gestures in Parkinson Disease and Ataxia, sponsored by Herbert H. Lehman College, City University of New York. Terminated at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-26.

Sponsored by Herbert H. Lehman College, City University of New York · Not applicable, Interventional, and Treatment

Why this study was terminated
Results showing no effect
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
21 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,649 studies in Parkinson Disease with a site in United States — 304 open to participants now, 387 under way, 7 of them phase 3. Parkinson Disease · United States.

Enrollment
1,152nd of 1,256
6 · median 36
Started
2018
with 89 others
No phase
585 of 1,649
146 open now
Registered
890th of 1,649
by date

Among the 1,649 studies in Parkinson Disease with a site in United States, this one is the 1,152nd largest by enrollment of the 1,256 interventional ones, is one of 90 that started in 2018, is one of 585 with no phase, and was the 890th registered.

By phase

1,649 studies; the count open now beside each. This study's row is marked.

No phasethis study585 · 146 open
Observational381 · 75 open
Phase 2234 · 25 open
Phase 1175 · 32 open
Phase 3126 · 2 open
Phase 475 · 11 open
Phase 1/251 · 11 open
Phase 2/319 · 2 open
Other kind3 · 0 open

By the year they started

First in 1991; this study’s year is marked. 90 started in 2018.

Size and results

Median enrollment 36 across the 1,256 interventional studies, 78 across the 379 observational. Of the 1,139 that completed or were terminated, 435 (38%) have results posted.

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02

Study summary

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.

Read the 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.

03

Conditions studied

  • Parkinson Disease
  • Ataxia

Keywords

  • speech rhythm
  • speech therapy
04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Cognitive impairment that prevents participation in the therapy
  • Fluent speakers of languages other than English or Spanish
  • younger than 21 years
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Gestures

    Use of hand gestures to improve speech rhythm and speech production

    Behavioral: Gestures

  • Experimental
    Auditory

    Use of auditory cues to improve speech rhythm and speech production

    Behavioral: Auditory

Interventions

  • BehavioralAuditory

    Use of auditory cues to improve speech production

  • BehavioralGestures

    Use of gestures to improve speech production

06

What researchers measure

Primary outcomes

  1. Intelligibility

    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

    Time frame: immediately upon completion of the therapy

Secondary outcomes

  1. Ease of understanding

    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

    Time frame: Immediately upon completion of the therapy

  2. Speech naturalness

    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

    Time frame: immediately upon completion of the therapy

07

Study locations

1 site
  • Lehman College
    Bronx, New York 10468, United States
08

References and documents

Individual participant data

Plan to share: Yes — De-identified data will be shared with other researchers

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: After completion of the study and publication of the data

Access criteria: Researchers who have contacted me directly with clear purpose and plan for use of data and then have IRB approval.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2018 to primary completion in Feb 2019, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2018
First posted
Aug 24, 2018
StartActual
Sep 1, 2018
Primary completionActual
Feb 20, 2019
CompletionActual
Feb 20, 2019
Last update
Feb 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03645265
Lead sponsor
Herbert H. Lehman College, City University of New York
Collaborators
University of Utah
Responsible party
Sponsor
First posted
Aug 24, 2018
Start date
Sep 1, 2018
Primary completion
Feb 20, 2019
Completion
Feb 20, 2019
Last update
Feb 26, 2019

Study contacts

Alison Behrman, PhD
principal investigator · Lehman College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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