Clinical trial NCT06593860: Dysarthria Management for Minor Groups
Official title: Toward a Dysarthria Management Model for Linguistically and Culturally Diverse Groups: Foreign Born Immigrants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Dysarthria
Keywords: speech
mental health
diversity
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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\&#39;s disease and their caregivers.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Speech Intelligibility Score on a Visual Analogue Scale
timeFrame: Immediately after and 6 months after treatment
measure: Vowel Space Area (kHz)
timeFrame: Immediately after and 6 months after treatment
measure: Speaking Rate (syl/s)
timeFrame: Immediately after and 6 months after treatment
Secondary outcomes:
measure: Dysarthria Impact Profile (DIP)
timeFrame: Immediately after and 6 months after treatment
measure: Everyday Communication Measure
timeFrame: Immediately after and 6 months after treatment
measure: Quality of Family Life Scale
timeFrame: Immediately after and 6 months after treatment
measure: Perceived Stress Scale
timeFrame: Immediately after and 6 months after treatment
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Yunjung Kim
role: PRINCIPAL_INVESTIGATOR
References: