An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD
Primary Purpose
Parkinson's Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combined speech and exercise intervention
Health education
Sponsored by
About this trial
This is an interventional other trial for Parkinson's Disease focused on measuring Parkinson's disease, Dysarthria, Speech therapy
Eligibility Criteria
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
Sites / Locations
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Combined speech and exercise intervention
Control group
Arm Description
Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance.
Health education
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04617496
First Posted
October 29, 2020
Last Updated
May 30, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04617496
Brief Title
An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD
Official Title
An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Dysarthria, Speech therapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Combined speech and exercise intervention
Arm Type
Experimental
Arm Description
Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Health education
Intervention Type
Behavioral
Intervention Name(s)
Combined speech and exercise intervention
Intervention Description
Home-based exercise intervention with interactive automated speech response features
Intervention Type
Behavioral
Intervention Name(s)
Health education
Intervention Description
Provision of general information about a variety of topics
Primary Outcome Measure Information:
Title
Speech Intelligibility
Description
Change in speech intelligibility from baseline to 6-month follow-up is the outcome, which will be based on analysis of acoustic recordings.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niquel Ortega
Phone
(857) 364-5669
Email
Niquel.Ortega@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David William Sparrow, DSc
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130-4817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niquel Ortega
Phone
(857) 364-5669
Email
Niquel.Ortega@va.gov
First Name & Middle Initial & Last Name & Degree
David William Sparrow, DSc
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An RCT of a Telemedicine Intervention for Hypokinetic Dysarthria in PD
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