NCT04617496

An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD

Completed NA Results posted Last updated 7 January 2026

What this trial tests

NA trial testing Combined speech and exercise intervention in Parkinson's Disease in 104 participants. Completed in 30 April 2025.

Timeline

1 July 2021

Primary endpoint
30 November 2024

30 April 2025

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	104
Start date	1 July 2021
Primary completion	30 November 2024
Estimated completion	30 April 2025
Sites	1 location across United States

Drugs / interventions tested

• Combined speech and exercise intervention
• Health education

Conditions studied

• Parkinson's Disease — all drugs for Parkinson's Disease →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 40 to 89, any sex, with Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Speech Intelligibility at 6 Months Primary · Baseline and 6-month Follow-up

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 wit

Group	Value	95% CI
Combined Speech and Exercise Intervention	0.25	-23.5 – 28.6
Control Group	-4.78	-45.9 – 24.4

Change in in Self-perceived Communication Ability Measured Via the Communication Effectiveness Index (CETI-M) at 6 Months Secondary · Baseline and 6-month Follow-up

CETI-M is a self-reported instrument assessing participants' communicative effectiveness in 10 different speaking situations (e.g., in noisy environments; over the phone) on a 10-point Likert scale, where 1 = not effective and 10 = extremely effective. Possible scores range from 10 (worst rated effectiveness) to 100 (best rated effectiveness). Change = (6-month score - Baseline score)

Group	Value	95% CI
Combined Speech and Exercise Intervention	6.8	-33.1 – 57.0
Control Group	-6.4	-55.0 – 32.0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.