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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined speech and exercise intervention | Experimental | Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. |
|
| Control group | Active Comparator | Health education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined speech and exercise intervention | Behavioral | Home-based exercise intervention with interactive automated speech response features |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David W Sparrow, DSc | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130-4817 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combined Speech and Exercise Intervention | Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. Combined speech and exercise intervention: Home-based exercise intervention with interactive automated speech response features |
| FG001 | Control Group | Health education Health education: Provision of general information about a variety of topics |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Combined Speech and Exercise Intervention | Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. Combined speech and exercise intervention: Home-based exercise intervention with interactive automated speech response features |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Full Range | score on a scale | Baseline and 6-month Follow-up |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combined Speech and Exercise Intervention | Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. Combined speech and exercise intervention: Home-based exercise intervention with interactive automated speech response features |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Sparrow | VA Boston Healthcare System | 857-364-6407 | david.sparrow@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2020 | Nov 5, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 1, 2024 | Jul 8, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D004401 | Dysarthria |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Health education | Behavioral | Provision of general information about a variety of topics |
|
| Baseline and 6-month Follow-up |
| Control Group |
Health education Health education: Provision of general information about a variety of topics |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Speech Intelligibility | Speech intelligibility is the degree to which spoken language can be understood by a listener and measured by the percentage of words 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. Possible scores range from 0 (no words understood) to 100 (all words understood). (please see outcomes section for full description) | Mean | Standard Deviation | units on a scale |
|
| Communication Effectiveness Score | Possible scores range from 10 (worst rated effectiveness) to 100 (best rated effectiveness). | Mean | Standard Deviation | units on a scale |
|
| OG000 |
| Combined Speech and Exercise Intervention |
Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance. Combined speech and exercise intervention: Home-based exercise intervention with interactive automated speech response features |
| OG001 | Control Group | Health education Health education: Provision of general information about a variety of topics |
|
|
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| Secondary | 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) | Posted | Mean | Full Range | score on a scale | Baseline and 6-month Follow-up |
|
|
|
|
| 2 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Control Group | Health education Health education: Provision of general information about a variety of topics | 1 | 54 | 0 | 54 | 0 | 54 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001184 | Articulation Disorders |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |