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Parkinson DiseaseNCT06593860

Dysarthria Management for Minor Groups

A study testing Remote speech rehabilitation in people with Parkinson Disease and Dysarthria, run by Florida State University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study develops and conduct a small-scale clinical trial study in which the linguistic and cultural diversity of the participants is considered. Speech therapy and counseling services are provided to both patients with Parkinson\'s disease and their caregivers. Read more about this study

Who is it for?
Ages 25 to 85 years
Conditions the study is for
Parkinson Disease, Dysarthria
What is being tested?
Remote speech rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
5 Aug 2024to 28 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 25 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Medical diagnosis of PD
  • No history of other neurological disease
  • Native speaker of Korean
  • Age between 25 and 85
  • Diagnosis of dysarthria secondary to PD from an SLP
  • Self-reported typical hearing
  • Access to high-speed internet for therapy sessions

Who cannot join

  • A score of 23 or below on the Korean Montreal Cognitive Assessment
  • Evidence of voice-speech disorders not-related to PD
  • Received speech therapy for PD-related problems in the past one year
  • Have no family members to participate in the project.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Florida State University

    Tallahassee, Florida, 32309

Other trials in United States

About this study

Official title: Toward a Dysarthria Management Model for Linguistically and Culturally Diverse Groups: Foreign Born Immigrants

This study develops and conduct a small-scale clinical trial study in which the linguistic and cultural diversity of the participants is considered. Speech therapy and counseling services are provided to both patients with Parkinson\'s disease and their caregivers.

Read the detailed description

Attention has been increasingly paid to the "culturally and linguistically diverse (CLD)" communities which typically include dialectal users of English, monolingual and multilingual speakers of minority languages, and bilingual speakers of English and a minority language. However, among these, monolingual speakers of minority languages living in the US have been nearly excluded from dysarthria management. Most of these are first-generation immigrants who are well documented to have limited access to financial and medical services and have poorer health outcomes including communication difficulties. This creates critical health disparities in the field of communication rehabilitation.

This study will (1) examine effects of speech therapy on PD patients' speech acoustics and intelligibility, (2) examine effects of the intervention program on communication participation and well-being of both PD patients and their families. Our primary outcome measures, speech intelligibility and acoustic measures, are hypothesized to show improvements. Acoustic predictors of speech intelligibility are expected to include acoustic vowel space and voice onset time. These hypotheses are based on literature reporting (1) positive changes in speech function after intensive treatment programs focusing on vocal effort and hyperarticulation and (2) language-specific contributors to speech intelligibility in PD. Our secondary outcome measures include (1) communication participation and (2) well-being measures which will be obtained from both PD patients and family members. Based on previous research, the measures are hypothesized to show improved communication participation and well-being in both PD patients and their families following therapy.

Being tested
Remote speech rehabilitation
Keywords
speech, mental health, diversity
Medical subject headings
Parkinson Disease, Dysarthria, Speech, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote speech rehabilitationBehavioural

    Two types of intervention will be provided via online to 32 dyads of people with Parkinson's disease: (1) speech therapy (PD patients) and (2) family education/training (PD families). Speech therapy will replicate the dose prescribed by many treatment programs including LSVT LOUD, LSVT ARTIC and Be Clear, consisting of 16 sessions of 50-60 minutes duration delivered over four weeks. Participants will also be set 15 to 20 minutes of daily home practice. Family education/training will take place once a week over 4 weeks.

Study groups in NCT06593860
Study groupRoleWhat they receive
Intervention: Behavioral, remote speech rehabilitation and counselingExperimentalSpeech therapy will replicate the dose prescribed by many treatment programs including LSVT LOUD, LSVT ARTIC and Be Clear, consisting of 16 sessions of 50-60 minutes duration delivered over four weeks. Participants will also be set 15 to 20 minutes of daily home practice. Family education/training will take place once a week over 4 weeks, including two components: family counseling (30 min) and family conversation training (30 min). Family counseling aims to increase the PD families' knowledge about PD in general and to identify goals and potential solutions to problems which cause emotional turmoil. Family conversation training which aims to increase the PD families' knowledge about PD-related communication problems and to raise awareness of their communication patterns, and to support the development of functional strategies. All activities will remotely occur (using Zoom).
Receives: Behavioral: Remote speech rehabilitation
No Intervention:Waitlist controlNo interventionNo intervention programs (speech therapy, counseling) will be provided.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Speech Intelligibility Score on a Visual Analogue Scale

    Speech intelligibility will be estimated using the visual analogue scale method. Listeners will rate the degree to which they understood the speech recordings on a continuous line. The two ends will be labeled, totally unintelligible and completely intelligible, respectively. Higher scores indicate more intelligible.

    Measured: Immediately after and 6 months after treatment

  2. Vowel Space Area (kHz)

    Two acoustic measures will be measured as Primary Outcome. The first one is the size of vowel space area, which has been frequently reported to correlate with speech intelligibility in people with Parkinson's disease.

    Measured: Immediately after and 6 months after treatment

  3. Speaking Rate (syl/s)

    The second acoustic measures to be included as Primary Outcome is speaking rate. This will be reported as the number of syllables produced in one second.

    Measured: Immediately after and 6 months after treatment

Secondary outcomes (4)

  1. Dysarthria Impact Profile (DIP)

    DIP is an assessment tool designed to measure the psychosocial impact of dysarthria on affected individuals. It consists of several sections with statements rated on a five-point scale, ranging from "strongly agree" to "strongly disagree." DIP incorporates positively and negatively worded statements with differing scoring schemes. This will be obtained from people with Parkinson's disease. Higher scores indicate greater impact of dysarthria.

    Measured: Immediately after and 6 months after treatment

  2. Everyday Communication Measure

    Family members will also be asked to rate five different aspects of the PD participant's everyday communication abilities using Everyday Communication Measures on a scale of 1 (poor) to 7 (very good). Example questions include, "how easy is it to understand the speaker?" and "how often does the speaker initiate conversation with you?". This will be obtained from family members of PD participants. Lower scores indicate greater difficulties of everyday communication.

    Measured: Immediately after and 6 months after treatment

  3. Quality of Family Life Scale

    The Family Quality of Life Scale (FQOL) is a 25-item instrument used to measure several aspects of families' perceived satisfaction in terms of quality of family life (e.g., family interaction, emotional well-being, physical/material well-being, and disability-related support). It uses a 1(very dissatisfied)-5 (very satisfied) Likert scale. Higher scores indicated a better quality of family life.

    Measured: Immediately after and 6 months after treatment

  4. Perceived Stress Scale

    The Perceived Stress Scale (PSP) will be used for measuring psychological stress. Among the three versions of the PSS, the Korean version of PSS-10 will be used. It uses a 0 (never)-4 (very often) Likert scale. Higher scores indicate more stress.

    Measured: Immediately after and 6 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start5 Aug 2024
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Mar 2027 (estimated)

Resources

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
Randomised
Intervention model
Crossover
Model description
A total of 32 dyads of PD participants will be recruited (4 groups of 8 participants in each). The PD participants must be monolingual speakers of Korean living in the United States. Using the waitlist randomized controlled trial (RCT) design, three wait control groups (Groups 2, 3, 4) will serve as untreated comparison groups first, but will serve as intervention groups in the following cycle. The proposed study is divided into two kinds of outcome measures, primary (speech function of PD patients) and secondary (communication participation and well-being of PD patients and their families). Each set of outcome measures will address one of the Specific Aims.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06593860
Sponsor's protocol ID
STUDY00003763
Status last verified
Jun 2026
First submitted
6 Sep 2024
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Remote speech rehabilitation in people with Parkinson Disease and Dysarthria, run by Florida State University 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 7 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Speech Intelligibility Score on a Visual Analogue Scale (time frame: Immediately after and 6 months after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06593860.

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 3 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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