Dysarthria Management for Minor Groups

NCT ID: NCT06593860

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-05

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson Disease Dysarthria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Due to the interactive nature of rehabilitation, masking the intervention to patients and research investigators is impossible. Therefore, we will blind the separate outcome assessors, who will not be involved in the treatment procedures to minimize bias.

Study Groups

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Intervention: Behavioral, remote speech rehabilitation and counseling

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, 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).

Group Type EXPERIMENTAL

Remote speech rehabilitation

Intervention Type BEHAVIORAL

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.

No Intervention:Waitlist control

No intervention programs (speech therapy, counseling) will be provided.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Remote speech rehabilitation

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Florida State University

OTHER

Sponsor Role lead

Responsible Party

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Yunjung Kim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yunjung Kim

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

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Florida State University

Tallahassee, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yunjung Kim

Role: CONTACT

8506454804

Eun-Jeong Lee

Role: CONTACT

Facility Contacts

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Yunjung Kim, PhD

Role: primary

850-645-4804

Other Identifiers

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STUDY00003763

Identifier Type: -

Identifier Source: org_study_id

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