Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Dysarthria, Speech therapy
Brief 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 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.
Interventions
BEHAVIORALCombined speech and exercise intervention
Home-based exercise intervention with interactive automated speech response features
BEHAVIORALHealth education
Provision of general information about a variety of topics
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Speech Intelligibility at 6 Months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in in Self-perceived Communication Ability Measured Via the Communication Effectiveness Index (CETI-M) at 6 Months | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| Control Group Health education
Health education: Provision of general information about a variety of topics | 54 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Lost to Follow-up | 3 | 3 |
Baseline characteristics
| Characteristic | Combined Speech and Exercise Intervention | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 76.5 years STANDARD_DEVIATION 5.5 | 73.5 years STANDARD_DEVIATION 6.5 | 74.9 years STANDARD_DEVIATION 6.2 |
| Communication Effectiveness Score | 50.6 units on a scale STANDARD_DEVIATION 18.2 | 57.5 units on a scale STANDARD_DEVIATION 14.1 | 54.2 units on a scale STANDARD_DEVIATION 16.5 |
| Race/Ethnicity, Customized Race/Ethnicity Black | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White, Non-Hispanic | 50 Participants | 53 Participants | 103 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 50 Participants | 54 Participants | 104 Participants |
| Speech Intelligibility | 48.7 units on a scale STANDARD_DEVIATION 23 | 46.5 units on a scale STANDARD_DEVIATION 18.4 | 47.7 units on a scale STANDARD_DEVIATION 20.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 50 | 1 / 54 |
| other Total, other adverse events | 0 / 50 | 0 / 54 |
| serious Total, serious adverse events | 0 / 50 | 0 / 54 |
Outcome results
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)
Time frame: Baseline and 6-month Follow-up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combined Speech and Exercise Intervention | Change in Speech Intelligibility at 6 Months | 0.25 score on a scale |
| Control Group | Change in Speech Intelligibility at 6 Months | -4.78 score on a scale |
p-value: 0.13Mixed Models Analysis
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)
Time frame: Baseline and 6-month Follow-up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Combined Speech and Exercise Intervention | Change in in Self-perceived Communication Ability Measured Via the Communication Effectiveness Index (CETI-M) at 6 Months | 6.8 score on a scale |
| Control Group | Change in in Self-perceived Communication Ability Measured Via the Communication Effectiveness Index (CETI-M) at 6 Months | -6.4 score on a scale |
p-value: <0.01Wilcoxon (Mann-Whitney)