An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD

NCT04617496 | Completed Results

• 1 other identifier: E3378-R
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Nearly 90% of people with Parkinson's disease have speech and voice disorders that negatively impact their ability to communicate effectively in daily life. This study will test the hypothesis that a combined speech and exercise intervention will improve speech intelligibility in people with Parkinson's disease and speech impairment. This approach would offer an affordable way to continue to both instruct and encourage training by Veterans virtually indefinitely through the remote access technology. These findings may help VA clinicians provide optimal care for the many Veterans with Parkinson's disease and speech impairment.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Dysarthria; Speech therapy

Outcome Measures

Primary Outcomes (1)

• Change in Speech Intelligibility at 6 Months

  Speech intelligibility is the degree to which spoken language can be understood by a listener. It is measured by the percentage of words that are understood from a recording of a participant reading a random set of 11 sentences from the Assessment of Intelligibility in Dysarthric Speech Sentence Intelligibility Test stimulus bank. Native speakers of American English listened to these recordings to assess speech intelligibility. These listeners were between the ages of 18 and 35 with no history of speech, language, or hearing disorders or experience rating speech. Each listener was provided with one sentence from each study participant's recording. Listeners were asked to transcribe each sentence to the best of their ability. Their transcriptions were compared with the actual sentences to calculate the percentage of words that were understood. Possible scores range from 0 (no words understood) to 100 (all words understood). Change = (6-month score - Baseline score)

  Baseline and 6-month Follow-up

Secondary Outcomes (1)

• Change in in Self-perceived Communication Ability Measured Via the Communication Effectiveness Index (CETI-M) at 6 Months

  Baseline and 6-month Follow-up

Study Arms (2)

Combined speech and exercise intervention

EXPERIMENTAL

Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance.

Behavioral: Combined speech and exercise intervention

Control group

ACTIVE COMPARATOR

Health education

Behavioral: Health education

Interventions

Health education BEHAVIORAL

Provision of general information about a variety of topics

Control group

Combined speech and exercise intervention BEHAVIORAL

Home-based exercise intervention with interactive automated speech response features

Combined speech and exercise intervention

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician diagnosis of idiopathic Parkinson's disease (PD)
• At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia)
• Response to dopaminergic medication
• Hypokinetic dysarthria

You may not qualify if:

• Angina pectoris
• History of myocardial infarction (MI) within 6 months
• History of ventricular dysrhythmia requiring current therapy

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Dysarthria; Communication Disorders

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; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. David Sparrow
• Organization: VA Boston Healthcare System

david.sparrow@va.gov

857-364-6407

Study Officials

• David W Sparrow, DSc

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 5, 2020
• Study Start: July 1, 2021
• Primary Completion: November 30, 2024
• Study Completion: April 30, 2025
• Last Updated: January 7, 2026
• Results First Posted: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)