Voice Treatment for Parkinson's Disease
A Comparison of Two Forms of Intensive Voice Treatment for Parkinson's Disease
2 other identifiers
interventional
36
1 country
2
Brief Summary
This study addresses several issues related to the clinical management of speech and voice disorders associated with Parkinson's disease. Two behavioral treatment programs, Lee Silverman Voice Treatment and SpeechVive, are assessed in their ability to improve communication in persons with Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2018
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2018
CompletedFirst Submitted
Initial submission to the registry
October 4, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedResults Posted
Study results publicly available
May 30, 2023
CompletedMay 30, 2023
May 1, 2023
1.5 years
October 4, 2018
April 13, 2023
May 2, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
Treatment-related Changes in Vocal Intensity Will be Assessed Using Acoustic Analysis.
Vocal intensity (dB SPL) will be measured during a reading task and a monologue task. The vocal intensity data reported will be collapsed across the reading and monologue task. Recorded speech samples are captured using a head-mounted microphone. The speech signals are analyzed for vocal intensity using Praat. The pre- to post-treatment change in vocal intensity is reported in decibels. A positive value indicates an increase in vocal intensity post-treatment. A negative value indicates a decrease in vocal intensity post-treatment. We expected to see no change in vocal intensity for the control group as they did not receive voice intervention.
Change from baseline after 8 weeks of treatment
Treatment-related Changes in Speech Breathing Will be Assessed Using Respiratory Kinematics.
Changes in speech breathing will be assessed by examining movement in the ribcage and abdominal walls (respiratory kinematics) during speech. Non-invasive elasticized bands are fitted around the chest and abdominal walls to monitor movement. Respiratory kinematic measures will be in percentage of vital capacity relative to end-expiratory level. Negative values for lung volume termination indicate that speech was terminated below end-expiratory level. Positive values for lung volume termination indicate that speech was terminated above end-expiratory level. The data reported show the baseline and post-treatment values for lung volume initiation, termination, and excursion as a percentage of vital capacity relative to end-expiratory level.
Change from baseline after 8 weeks of treatment
Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (Open Quotient)
Movement of air through the vocal folds will also be assessed during a vowel and sentence production task using a vented mask that fits over the nose and mouth. This allows us to derive estimates of how long the vocal folds are open (open quotient). Pre-treatment and post-treatment values are reported. Open quotient is a unit-less measure.
Change from baseline after 8 weeks of treatment
Assessing Mental and Physical Effort Associated With Each Treatment Program Using the Modified National Aeronautics and Space Administration (NASA)-Task Load Index
Ratings of physical and mental effort will be assigned by participants on treatment days using the modified NASA-Task Load Index. Participants rate how much physical effort and mental effort it took to complete treatment each day. Participants will indicate their response using a visual analogue scale (0-100) with the endpoints "no effort" ("0") to "significant effort" ("100"). Data are not reported for the clinical control group as these participants did not receive treatment. Ratings of mental and physical effort are reported separately at baseline and post-treatment.
Change from baseline after 8 weeks of treatment
Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (MFDR)
Movement of air through the vocal folds will also be assessed during a vowel and sentence production task using a vented mask that fits over the nose and mouth. This allows us to derive estimates of how quickly the vocal folds are closing (maximum flow declination rate). Pre-treatment and post-treatment values are reported. Maximum flow declination rate (MFDR) is reported in liters per second per second (L/s/s).
Change from baseline after 8 weeks of treatment
Secondary Outcomes (5)
Treatment-related Changes in Quality of Life Will be Assessed Using the Parkinson's Disease Questionnaire (PDQ-39)
Change from baseline after 8 weeks of treatment
Treatment-related Changes in Communicative Competence Will be Assessed Using the Communicative Participation Item Bank-Short Form Questionnaire
Change from baseline after 8 weeks of treatment
Treatment-related Changes in Activities of Daily Living Assessed by the Voice-related Quality of Life (VR-QOL) Questionnaire
Change from baseline after 8 weeks of treatment
Treatment-related Changes in Speech Rate Will be Assessed Using Acoustic Analysis.
Change from baseline after 8 weeks of treatment
Treatment-related Changes in Speech Pauses Will be Assessed Using Acoustic Analysis.
Change from baseline after 8 weeks of treatment
Study Arms (3)
Lee Silverman Voice Treatment
EXPERIMENTALPersons with Parkinson's disease receive Lee Silverman Voice Treatment over an eight week period. Four weeks of face-to-face intervention and four weeks of home practice.
SpeechVive
EXPERIMENTALPersons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
Control
ACTIVE COMPARATORPersons with Parkinsons disease do not receive voice intervention
Interventions
Persons with Parkinson's disease receive sixteen hours of voice treatment over a four week period. Participants will practice the vocal exercises at home for an additional four weeks.
Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
Persons assigned to the non-treatment control group will not participate in voice treatment.
Eligibility Criteria
You may qualify if:
- Diagnosis of Parkinson's disease
- Problems with speech loudness due to Parkinson's disease
- No asthma or other respiratory problems
- No head, neck or chest surgery (Pacemaker surgery is okay)
- Non-smoking for the last 5 years
- Not currently participating in another treatment study
- Typical cognitive skills
- Free of symptoms of depression
- Unaided hearing in at least one ear
- No voice therapy or voice therapy maintenance within the last 12 months
You may not qualify if:
- Other neurological diseases, other than Parkinson's disease
- History of asthma or respiratory problems
- Head, neck or chest surgery
- Smoker within the last 5 years
- Currently involved in another treatment study
- Decreased cognition
- Symptoms of depression
- Wear a hearing aid in both ears
- Participated in voice therapy within the last 12 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Purdue University
West Lafayette, Indiana, 47907, United States
University of Massachusetts Amherst
Amherst, Massachusetts, 01040, United States
Related Publications (5)
Stathopoulos ET, Huber JE, Richardson K, Kamphaus J, DeCicco D, Darling M, Fulcher K, Sussman JE. Increased vocal intensity due to the Lombard effect in speakers with Parkinson's disease: simultaneous laryngeal and respiratory strategies. J Commun Disord. 2014 Mar-Apr;48:1-17. doi: 10.1016/j.jcomdis.2013.12.001. Epub 2013 Dec 28.
PMID: 24438910RESULTRichardson K, Sussman JE, Stathopoulos ET. The effect of increased vocal intensity on interarticulator timing in speakers with Parkinson's disease: a preliminary analysis. J Commun Disord. 2014 Nov-Dec;52:44-64. doi: 10.1016/j.jcomdis.2014.09.004.
PMID: 25459460RESULTDarling M, Huber JE. Changes to articulatory kinematics in response to loudness cues in individuals with Parkinson's disease. J Speech Lang Hear Res. 2011 Oct;54(5):1247-59. doi: 10.1044/1092-4388(2011/10-0024). Epub 2011 Mar 8.
PMID: 21386044RESULTSadagopan N, Huber JE. Effects of loudness cues on respiration in individuals with Parkinson's disease. Mov Disord. 2007 Apr 15;22(5):651-9. doi: 10.1002/mds.21375.
PMID: 17266087RESULTHuber JE, Darling M. Effect of Parkinson's disease on the production of structured and unstructured speaking tasks: respiratory physiologic and linguistic considerations. J Speech Lang Hear Res. 2011 Feb;54(1):33-46. doi: 10.1044/1092-4388(2010/09-0184). Epub 2010 Sep 15.
PMID: 20844256RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kelly Richardson
- Organization
- University of Massachusetts Amherst
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly Richardson, Ph.D.
University of Massachusetts, Amherst
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Data files are coded to mask group assignment, session ID, and testing condition.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 4, 2018
First Posted
October 9, 2018
Study Start
September 19, 2018
Primary Completion
March 15, 2020
Study Completion
November 30, 2022
Last Updated
May 30, 2023
Results First Posted
May 30, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will become available once it has been deidentified and published in peer-reviewed journals.
- Access Criteria
- Any researcher requesting access to these data will need to submit to Kelly Richardson the following: 1. Name and institution of PI 2. Proof of institutional appointment 3. Names and roles for all individuals who will access the data for the planned analysis 4. Detailed plan for the use of the data 5. Timeline for the use and publication of the analysis.
The data from the persons with Parkinson's disease will include perceptions of physical and mental effort, objective measures of speech, voice, and respiratory function.