NCT03645265

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
terminated

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 21, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

August 21, 2018

Last Update Submit

February 22, 2019

Conditions

Keywords

speech rhythmspeech therapy

Outcome Measures

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

    immediately upon completion of the therapy

Secondary Outcomes (2)

  • Ease of understanding

    Immediately upon completion of the therapy

  • Speech naturalness

    immediately upon completion of the therapy

Study Arms (2)

Gestures

EXPERIMENTAL

Use of hand gestures to improve speech rhythm and speech production

Behavioral: Gestures

Auditory

EXPERIMENTAL

Use of auditory cues to improve speech rhythm and speech production

Behavioral: Auditory

Interventions

AuditoryBEHAVIORAL

Use of auditory cues to improve speech production

Auditory
GesturesBEHAVIORAL

Use of gestures to improve speech production

Gestures

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lehman College

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseAtaxiaCommunication Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Alison Behrman, PhD

    Lehman College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single case experimental design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 24, 2018

Study Start

September 1, 2018

Primary Completion

February 20, 2019

Study Completion

February 20, 2019

Last Updated

February 26, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

De-identified data will be shared with other researchers

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
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.

Locations