Voice Treatment for Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT03700684|
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : March 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Parkinson Disease||Behavioral: Lee Silverman Voice Treatment Device: SpeechVive Behavioral: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants are stratified by voice severity and assigned to one of three groups: Lee Silverman Voice Treatment (intervention), SpeechVive (intervention), or non-treatment control group (control).|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Data files are coded to mask group assignment, session ID, and testing condition.|
|Official Title:||A Comparison of Two Forms of Intensive Voice Treatment for Parkinson's Disease|
|Actual Study Start Date :||September 19, 2018|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||November 30, 2020|
Experimental: Lee Silverman Voice Treatment
Persons 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.
Behavioral: Lee Silverman Voice Treatment
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 receive eight weeks of voice treatment using the SpeechVive device.
Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
Active Comparator: Control
Persons with Parkinsons disease do not receive voice intervention
Persons assigned to the non-treatment control group will not participate in voice treatment.
- Treatment-related changes in speech breathing will be assessed using respiratory kinematics and laryngeal aerodynamics. [ Time Frame: Change from baseline after 8 weeks of treatment ]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 expressed in volts. Movement of air through the vocal folds will also be assessed during speech using a vented mask that fits over the nose and mouth (laryngeal aerodynamics). This allow us to derive estimates of how long the vocal folds are open (open quotient) and how quickly they are closing (maximum flow declination rate).
- Assessing mental and physical effort associated with each treatment program using the modified National Aeronautics and Space Administration (NASA)-Task Load Index [ Time Frame: Change from baseline after 8 weeks of treatment ]Ratings of physical and mental effort will be assigned by participants on treatment days using the modified NASA-Task Load Index. Participants will rate how much physical effort and mental effort it took to complete treatment that day. Participants will indicate their response using a visual analogue scale with the endpoints "no effort" "significant effort".
- Treatment-related changes in vocal intensity will be assessed using acoustic analysis. [ Time Frame: Change from baseline after 8 weeks of treatment ]Vocal intensity (dB SPL) will be measured during a reading task and a monologue task. Recorded speech samples are captured using a head-mounted microphone. The speech signals are analyzed for vocal intensity using acoustic software programs. Higher values of vocal intensity represent a louder speaking volume.
- Treatment-related changes in quality of life will be assessed using the Parkinson's Disease Questionnaire (PDQ-39) [ Time Frame: Change from baseline after 8 weeks of treatment ]This 39-item self-report questionnaire is designed to address aspects of functioning and well-being for those affected by Parkinson's disease. The PDQ-39 scores each item on a 5 point scale (1=never, 5=always) and is scored along 8 discrete scales: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. A summary index score is calculated by averaging the scores obtained across the 8 discrete scales. For the discrete scales and the summary score, lower scores represent a better quality of life.
- Treatment-related changes in communicative competence will be assessed using the Communicative Participation Item Bank-Short Form Questionnaire [ Time Frame: Change from baseline after 8 weeks of treatment ]The Communicative Participation Item Bank-Short Form is a 10-item self-report questionnaire that examines how a given condition (e.g. Parkinson's disease) interferes with communication in various situations (e.g. noisy environment). The questionnaire has 10 questions that depict a variety of speaking situations. Each of the 10 questions is assigned a score between 0 (very much) to 3 (not at all). Participants are asked to indicate how much their condition interferes with participation in each situation. The scores are summed to come up with a summary score between 0 and 30. High scores indicate less interference in participation.
- Treatment-related changes in activities of daily living assessed by the Voice-related Quality of Life (V-RQOL) Questionnaire [ Time Frame: Change from baseline after 8 weeks of treatment ]The Voice-related Quality of Life instrument is a 10-item self-report questionnaire that examines the impact of a persons voice impairment on activities of daily living. For each item, participants assign a score between 1 (Not a problem) and 5 (Problem is as bad as can be). A total score is calculated by summing the assigned scores across the 10 items. Higher scores indicate that the voice problem interferes with activities of daily living.
- Treatment-related changes in spoken language will be assessed using a narrative analysis. [ Time Frame: Change from baseline after 8 weeks of treatment ]Participants are asked to tell a story about the people and events depicted in a picture array. The recorded speech sample is analyzed to assess expressive language skills including measures of pause duration and syntactic structure.
- Treatment-related changes in speech rate will be assessed using acoustic analysis. [ Time Frame: Change from baseline after 8 weeks of treatment ]While wearing a microphone, participants will read a short passage and provide a monologue on a topic of their choice. These recorded speech samples will be analyzed for speech rate using an acoustic software program. Speech rate is measured and reported in syllables per second. Higher values indicate a faster speech rate.
- Treatment-related changes in speech pauses will be assessed using acoustic analysis. [ Time Frame: Change from baseline after 8 weeks of treatment ]While wearing a microphone, participants will read a short passage and provide a monologue on a topic of their choice. These recorded speech samples will be analyzed for filled and unfilled pauses using an acoustic software program. Pauses are reported as a frequency count (how many occur in a given sample) and the average duration of the pauses (in msec).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700684
|Contact: Kelly Richardson, Ph.D.||firstname.lastname@example.org|
|United States, Indiana|
|West Lafayette, Indiana, United States, 47907|
|Contact: Jessica Huber, Ph.D. 765-494-3796 email@example.com|
|Contact: Sandy Snyder 765-494-6488 firstname.lastname@example.org|
|United States, Massachusetts|
|University of Massachusetts Amherst||Recruiting|
|Amherst, Massachusetts, United States, 01040|
|Contact: Kelly Richardson, Ph.D.|
|Principal Investigator:||Kelly Richardson, Ph.D.||University of Massachusetts, Amherst|