An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD

Study Overview
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Brief Summary
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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
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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.

Official Title
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An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: Combined speech and exercise intervention
* Behavioral: Health education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Angina pectoris History of myocardial infarction (MI) within 6 months History of ventricular dysrhythmia requiring current therapy

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined speech and exercise intervention<br>Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. | Behavioral: Combined speech and exercise intervention<br>* Home-based exercise intervention with interactive automated speech response features<br>|
| Active Comparator: Control group<br>Health education | Behavioral: Health education<br>* Provision of general information about a variety of topics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Intelligibility | Change in speech intelligibility from baseline to 6-month follow-up is the outcome, which will be based on analysis of acoustic recordings. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Dysarthria, Speech therapy