Parkinson's DiseaseNCT04617496
An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD
A study testing Combined speech and exercise intervention and Health education in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Combined speech and exercise intervention and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Angina pectoris
- History of myocardial infarction (MI) within 6 months
- History of ventricular dysrhythmia requiring current therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
About this study
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.
Read the detailed description
Background/Rationale The great majority of individuals with Parkinson's disease (PD) develop speech impairments, most of which are grouped together and called hypokinetic dysarthria. Hypokinetic dysarthria is typically characterized by altered prosody (e.g., reduced loudness and pitch variation), phonation (e.g., breathy or harsh voice), and articulation (e.g., imprecise consonants, centralized vowels). Changes in speech may appear early in PD and progress in severity over time. Further, such changes in speech lead to significant declines in functional communication and quality of life. Pharmacological and surgical interventions that alleviate motor symptoms in PD are largely ineffective or sometimes even detrimental for speech.
Objectives Based on results from a preliminary study, the investigators propose to conduct a pilot randomized, controlled trial in patients with hypokinetic dysarthria in PD to assess the potential effectiveness of a novel home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. The investigators hypothesize that patients in the intervention program will improve in speech intelligibility and self-perceived communication ability over 6 months, as compared with patients in a health education program.
Methods A total of 104 community-dwelling Veterans with hypokinetic dysarthria in mild-to-moderate PD will be randomly assigned to the exercise intervention or to the health education control. The investigators will test the effects of the intervention at 6 months for the outcomes speech intelligibility and self-perceived communication ability.
- Conditions
- Parkinson's Disease
- Being tested
- Combined speech and exercise intervention, Health education
- Keywords
- Parkinson's disease, Dysarthria, Speech therapy
- Medical subject headings
- Parkinson Disease, Dysarthria, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined speech and exercise interventionBehavioural
Home-based exercise intervention with interactive automated speech response features
Health educationBehavioural
Provision of general information about a variety of topics
| Study group | Role | What they receive |
|---|---|---|
| Combined speech and exercise intervention | Experimental | Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. Receives: Behavioral: Combined speech and exercise intervention |
| Control group | Active comparator | Health education Receives: Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: Baseline and 6-month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Jul 2021
- Primary completion30 Nov 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David W Sparrow, DSc, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617496
- Sponsor's protocol ID
- E3378-R
- Status last verified
- Dec 2025
- First submitted
- 29 Oct 2020
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD
- ClinicalTrials.gov ID
- NCT04617496
- Acronym / sponsor ID
- E3378-R
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Dysarthria, Speech therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Posted 7 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background/Rationale The great majority of individuals with Parkinson's disease (PD) develop speech impairments, most of which are grouped together and called hypokinetic dysarthria. Hypokinetic dysarthria is typically characterized by altered prosody (e.g., reduced loudness and pitch variation), phonation (e.g., breathy or harsh voice), and articulation (e.g., imprecise consonants, centralized vowels). Changes in speech may appear early in PD and progress in severity over time. Further, such changes in speech lead to significant declines in functional communication and quality of life. Pharmacological and surgical interventions that alleviate motor symptoms in PD are largely ineffective or sometimes even detrimental for speech.
Objectives Based on results from a preliminary study, the investigators propose to conduct a pilot randomized, controlled trial in patients with hypokinetic dysarthria in PD to assess the potential effectiveness of a novel home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. The investigators hypothesize that patients in the intervention program will improve in speech intelligibility and self-perceived communication ability over 6 months, as compared with patients in a health education program.
Methods A total of 104 community-dwelling Veterans with hypokinetic dysarthria in mild-to-moderate PD will be randomly assigned to the exercise intervention or to the health education control. The investigators will test the effects of the intervention at 6 months for the outcomes speech intelligibility and self-perceived communication ability.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined speech and exercise intervention | Experimental | Behavioral: Combined speech and exercise interventionHome-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. |
| Control group | Active comparator | Behavioral: Health educationHealth education |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Angina pectoris
- History of myocardial infarction (MI) within 6 months
- History of ventricular dysrhythmia requiring current therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined speech and exercise interventionHome-based exercise intervention with interactive automated speech response features | Behavioural | Combined speech and exercise intervention |
| Health educationProvision of general information about a variety of topics | Behavioural | Control group |
Primary outcome
Change in Speech Intelligibility at 6 Months
Time frame: 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 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)
1 secondary outcome
Change in in Self-perceived Communication Ability Measured Via the Communication Effectiveness Index (CETI-M) at 6 Months
Time frame: Baseline and 6-month Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David W Sparrow, DSc principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined speech and exercise intervention and Health education in people with Parkinson's Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Speech Intelligibility at 6 Months (time frame: Baseline and 6-month Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.