Dysarthria Management for Minor Groups

NCT06593860 | Recruiting

• 1 other identifier: STUDY00003763
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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\'s disease and their caregivers.

Conditions

Parkinson Disease; Dysarthria

Keywords

speech; mental health; diversity

Outcome Measures

Primary Outcomes (3)

• 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.

  Immediately after and 6 months after treatment

• 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.

  Immediately after and 6 months after treatment

• 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.

  Immediately after and 6 months after treatment

Secondary Outcomes (4)

• Dysarthria Impact Profile (DIP)

  Immediately after and 6 months after treatment

• Everyday Communication Measure

  Immediately after and 6 months after treatment

• Quality of Family Life Scale

  Immediately after and 6 months after treatment

• Perceived Stress Scale

  Immediately after and 6 months after treatment

Study Arms (2)

Intervention: Behavioral, remote speech rehabilitation and counseling

EXPERIMENTAL

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).

Behavioral: Remote speech rehabilitation

No Intervention:Waitlist control

NO INTERVENTION

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

Interventions

Remote speech rehabilitation 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.

Intervention: Behavioral, remote speech rehabilitation and counseling

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32309, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Dysarthria; Speech; Psychological Well-Being

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Verbal Behavior; Communication; Behavior; Personal Satisfaction

Study Officials

• Yunjung Kim

  Florida State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunjung Kim

CONTACT

8506454804; ykim19@fsu.edu

Eun-Jeong Lee

CONTACT

elee20@iit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: August 5, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

US (1)