An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02130-4817
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Control group
Health education
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Provision of general information about a variety of topics
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Experimental: Combined speech and exercise intervention
Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance.
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Home-based exercise intervention with interactive automated speech response features
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Speech Intelligibility at 6 Months
Time Frame: Baseline and 6-month Follow-up
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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)
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Baseline and 6-month Follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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) |
Baseline and 6-month Follow-up
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Collaborators and Investigators
Investigators
- Principal Investigator: David W Sparrow, DSc, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Synucleinopathies
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurodegenerative Diseases
- Neurodevelopmental Disorders
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Language Disorders
- Speech Disorders
- Articulation Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Parkinson Disease
- Communication Disorders
- Dysarthria
Other Study ID Numbers
- E3378-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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