Parkinson DiseaseNCT03645265
Rhythmic Entrainment in Bilingual Speakers With Dysarthria
A study testing Auditory and Gestures in people with Parkinson Disease and Ataxia, run by Herbert H. Lehman College, City University of New York at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Ataxia
- What is being tested?
- Auditory and Gestures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 20 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive impairment that prevents participation in the therapy
- Fluent speakers of languages other than English or Spanish
- younger than 21 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Parkinson Disease, Ataxia
- Being tested
- Auditory, Gestures
- Keywords
- speech rhythm, speech therapy
- Medical subject headings
- Parkinson Disease, Ataxia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuditoryBehavioural
Use of auditory cues to improve speech production
GesturesBehavioural
Use of gestures to improve speech production
| Study group | Role | What they receive |
|---|---|---|
| Gestures | Experimental | Use of hand gestures to improve speech rhythm and speech production Receives: Behavioral: Gestures |
| Auditory | Experimental | Use of auditory cues to improve speech rhythm and speech production Receives: Behavioral: Auditory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediately upon completion of the therapy
Secondary outcomes (2)
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
Measured: Immediately upon completion of the therapy
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
Measured: immediately upon completion of the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Sep 2018
- Primary completion20 Feb 2019
- Study completion20 Feb 2019
Why it stopped: Results showing no effect
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single case experimental design
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herbert H. Lehman College, City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah
- Responsible party
- Sponsor
- Investigators
- Alison Behrman, PhD, Principal investigator, Lehman College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645265
- Sponsor's protocol ID
- 2017-0851
- Status last verified
- Feb 2019
- First submitted
- 21 Aug 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhythmic Entrainment in Bilingual Speakers With Dysarthria
- ClinicalTrials.gov ID
- NCT03645265
- Acronym / sponsor ID
- 2017-0851
- Conditions
- Parkinson Disease, Ataxia
- Keywords
- speech rhythm, speech therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results showing no effect
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Herbert H. Lehman College, City University of New YorkUniversity, hospital or other
- Collaborators
- University of Utah
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single case experimental design
| Arm | Type | Receives |
|---|---|---|
| Gestures | Experimental | Behavioral: GesturesUse of hand gestures to improve speech rhythm and speech production |
| Auditory | Experimental | Behavioral: AuditoryUse of auditory cues to improve speech rhythm and speech production |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Cognitive impairment that prevents participation in the therapy
- Fluent speakers of languages other than English or Spanish
- younger than 21 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AuditoryUse of auditory cues to improve speech production | Behavioural | Auditory |
| GesturesUse of gestures to improve speech production | Behavioural | Gestures |
Primary outcome
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
2 secondary outcomes
Ease of understanding
Time frame: Immediately upon completion of the therapy
Speech naturalness
Time frame: immediately upon completion of the therapy
Results and safety
The study was stopped early (reason given: Results showing no effect). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Behrman, PhD principal investigator
Lehman College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory and Gestures in people with Parkinson Disease and Ataxia, run by Herbert H. Lehman College, City University of New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Results showing no effect). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intelligibility (time frame: immediately upon completion of the therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.