Trial Outcomes & Findings for Voice Treatment for Parkinson's Disease (NCT NCT03700684)
NCT ID: NCT03700684
Last Updated: 2023-05-30
Results Overview
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).
COMPLETED
NA
36 participants
Change from baseline after 8 weeks of treatment
2023-05-30
Participant Flow
Participant milestones
| Measure |
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.
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.
|
SpeechVive
Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
SpeechVive: Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
|
Control
Persons with Parkinsons disease do not receive voice intervention
Control: Persons assigned to the non-treatment control group will not participate in voice treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
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.
|
SpeechVive
Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
SpeechVive: Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
|
Control
Persons with Parkinsons disease do not receive voice intervention
Control: Persons assigned to the non-treatment control group will not participate in voice treatment.
|
|---|---|---|---|
|
Overall Study
COVID-19
|
0
|
0
|
2
|
Baseline Characteristics
Voice Treatment for Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Lee Silverman Voice Treatment
n=12 Participants
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.
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.
|
SpeechVive
n=12 Participants
Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
SpeechVive: Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
|
Control
n=10 Participants
Persons with Parkinsons disease do not receive voice intervention
Control: Persons assigned to the non-treatment control group will not participate in voice treatment.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 4.88 • n=5 Participants
|
69 years
STANDARD_DEVIATION 7.52 • n=7 Participants
|
67 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
68 years
STANDARD_DEVIATION 7.72 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Hoehn & Yahr
|
2.5 Units on a scale
STANDARD_DEVIATION 0.79 • n=5 Participants
|
2.75 Units on a scale
STANDARD_DEVIATION 1.05 • n=7 Participants
|
2.60 Units on a scale
STANDARD_DEVIATION 1.26 • n=5 Participants
|
2.62 Units on a scale
STANDARD_DEVIATION 1.02 • n=4 Participants
|
PRIMARY outcome
Timeframe: Change from baseline after 8 weeks of treatmentVocal 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.
Outcome measures
| Measure |
Lee Silverman Voice Treatment
n=12 Participants
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.
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.
|
SpeechVive
n=12 Participants
Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
SpeechVive: Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
|
Control
n=10 Participants
Persons with Parkinsons disease do not receive voice intervention
Control: Persons assigned to the non-treatment control group will not participate in voice treatment.
|
|---|---|---|---|
|
Treatment-related Changes in Vocal Intensity Will be Assessed Using Acoustic Analysis.
|
3 Decibels
Standard Deviation 1.4
|
3 Decibels
Standard Deviation 2.5
|
0.26 Decibels
Standard Deviation 0.23
|
PRIMARY outcome
Timeframe: Change from baseline after 8 weeks of treatmentPopulation: The primary goal was to ascertain the impact of internal cueing (SpeechVive) and external cueing (Lee Silverman Voice Treatment) on respiratory mechanics. To achieve this goal, and to ensure adequate statistical power was maintained, a direct treatment group comparison was undertaken. As a result, the clinical controls, who did not receive any form of intervention, were excluded from this analysis.
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.
Outcome measures
| Measure |
Lee Silverman Voice Treatment
n=12 Participants
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.
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.
|
SpeechVive
n=12 Participants
Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
SpeechVive: Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
|
Control
Persons with Parkinsons disease do not receive voice intervention
Control: 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.
Lung volume initiation (baseline)
|
22.89 percent change in vital capacity
Standard Deviation 20.14
|
21.75 percent change in vital capacity
Standard Deviation 13.31
|
—
|
|
Treatment-related Changes in Speech Breathing Will be Assessed Using Respiratory Kinematics.
Lung volume initiation (post-treatment)
|
17.87 percent change in vital capacity
Standard Deviation 15.81
|
20.73 percent change in vital capacity
Standard Deviation 8.90
|
—
|
|
Treatment-related Changes in Speech Breathing Will be Assessed Using Respiratory Kinematics.
Lung volume termination (baseline)
|
5.84 percent change in vital capacity
Standard Deviation 16.95
|
6.41 percent change in vital capacity
Standard Deviation 11.78
|
—
|
|
Treatment-related Changes in Speech Breathing Will be Assessed Using Respiratory Kinematics.
Lung volume termination (post-treatment)
|
-6.37 percent change in vital capacity
Standard Deviation 16.75
|
5.37 percent change in vital capacity
Standard Deviation 7.90
|
—
|
|
Treatment-related Changes in Speech Breathing Will be Assessed Using Respiratory Kinematics.
Lung volume excursion (baseline)
|
17.05 percent change in vital capacity
Standard Deviation 12.79
|
15.34 percent change in vital capacity
Standard Deviation 10.21
|
—
|
|
Treatment-related Changes in Speech Breathing Will be Assessed Using Respiratory Kinematics.
Lung volume excursion (post-treatment)
|
24.24 percent change in vital capacity
Standard Deviation 17.60
|
15.36 percent change in vital capacity
Standard Deviation 9.68
|
—
|
PRIMARY outcome
Timeframe: Change from baseline after 8 weeks of treatmentPopulation: The primary goal was to ascertain the impact of internal cueing (SpeechVive) and external cueing (Lee Silverman Voice Treatment) on laryngeal aerodynamics. To achieve this goal, and to ensure adequate statistical power was maintained, a direct treatment group comparison was undertaken. As a result, the clinical controls, who did not receive any form of intervention, were excluded from this analysis.
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.
Outcome measures
| Measure |
Lee Silverman Voice Treatment
n=12 Participants
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.
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.
|
SpeechVive
n=12 Participants
Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
SpeechVive: Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
|
Control
Persons with Parkinsons disease do not receive voice intervention
Control: Persons assigned to the non-treatment control group will not participate in voice treatment.
|
|---|---|---|---|
|
Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (Open Quotient)
Open Quotient (baseline)
|
0.72 No unit of measurement
Standard Deviation 0.05
|
0.71 No unit of measurement
Standard Deviation 0.13
|
—
|
|
Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (Open Quotient)
Open Quotient (post-treatment)
|
0.72 No unit of measurement
Standard Deviation 0.11
|
0.68 No unit of measurement
Standard Deviation 0.12
|
—
|
PRIMARY outcome
Timeframe: Change from baseline after 8 weeks of treatmentPopulation: Controls were excluded as the goal was to ascertain the impact of voice intervention on self-perception of physical and mental effort.
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.
Outcome measures
| Measure |
Lee Silverman Voice Treatment
n=12 Participants
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.
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.
|
SpeechVive
n=12 Participants
Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
SpeechVive: Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
|
Control
Persons with Parkinsons disease do not receive voice intervention
Control: Persons assigned to the non-treatment control group will not participate in voice treatment.
|
|---|---|---|---|
|
Assessing Mental and Physical Effort Associated With Each Treatment Program Using the Modified National Aeronautics and Space Administration (NASA)-Task Load Index
Mental effort (baseline)
|
60.07 units on a scale
Standard Deviation 23.53
|
35.23 units on a scale
Standard Deviation 30.19
|
—
|
|
Assessing Mental and Physical Effort Associated With Each Treatment Program Using the Modified National Aeronautics and Space Administration (NASA)-Task Load Index
Mental effort (post-treatment)
|
67.03 units on a scale
Standard Deviation 15.54
|
16.59 units on a scale
Standard Deviation 17.70
|
—
|
|
Assessing Mental and Physical Effort Associated With Each Treatment Program Using the Modified National Aeronautics and Space Administration (NASA)-Task Load Index
Physical effort (baseline)
|
65.32 units on a scale
Standard Deviation 18.24
|
22.31 units on a scale
Standard Deviation 11.13
|
—
|
|
Assessing Mental and Physical Effort Associated With Each Treatment Program Using the Modified National Aeronautics and Space Administration (NASA)-Task Load Index
Physical effort (post-treatment)
|
67.59 units on a scale
Standard Deviation 20.24
|
10.5 units on a scale
Standard Deviation 8.15
|
—
|
PRIMARY outcome
Timeframe: Change from baseline after 8 weeks of treatmentPopulation: The primary goal was to ascertain the impact of internal cueing (SpeechVive) and external cueing (Lee Silverman Voice Treatment) on laryngeal aerodynamics. To achieve this goal, and to ensure adequate statistical power was maintained, a direct treatment group comparison was undertaken. As a result, the clinical controls, who did not receive any form of intervention, were excluded from this analysis.
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).
Outcome measures
| Measure |
Lee Silverman Voice Treatment
n=12 Participants
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.
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.
|
SpeechVive
n=12 Participants
Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
SpeechVive: Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
|
Control
Persons with Parkinsons disease do not receive voice intervention
Control: Persons assigned to the non-treatment control group will not participate in voice treatment.
|
|---|---|---|---|
|
Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (MFDR)
Maximum flow declination rate (baseline)
|
194.31 L/s/s
Standard Deviation 83.69
|
239.90 L/s/s
Standard Deviation 200.25
|
—
|
|
Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (MFDR)
Maximum flow declination rate (post-treatment)
|
179.53 L/s/s
Standard Deviation 42.42
|
181.24 L/s/s
Standard Deviation 54.73
|
—
|
SECONDARY outcome
Timeframe: Change from baseline after 8 weeks of treatmentThis 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 (0=never, 4=always) and is scored along 8 different 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 across these 8 difference scales. The minimum score is 0 and the maximum score is 100. Lower scores indicate a better quality of life and higher scores indicate a lower quality of life. Summary index scores are reported for baseline and post-treatment.
Outcome measures
| Measure |
Lee Silverman Voice Treatment
n=12 Participants
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.
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.
|
SpeechVive
n=12 Participants
Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
SpeechVive: Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
|
Control
n=10 Participants
Persons with Parkinsons disease do not receive voice intervention
Control: Persons assigned to the non-treatment control group will not participate in voice treatment.
|
|---|---|---|---|
|
Treatment-related Changes in Quality of Life Will be Assessed Using the Parkinson's Disease Questionnaire (PDQ-39)
Baseline
|
18.61 score on a scale
Standard Deviation 10.27
|
23.04 score on a scale
Standard Deviation 9.04
|
26.74 score on a scale
Standard Deviation 16.95
|
|
Treatment-related Changes in Quality of Life Will be Assessed Using the Parkinson's Disease Questionnaire (PDQ-39)
Post-treatment
|
18.13 score on a scale
Standard Deviation 12.70
|
21.60 score on a scale
Standard Deviation 11.32
|
23.95 score on a scale
Standard Deviation 16.64
|
SECONDARY outcome
Timeframe: Change from baseline after 8 weeks of treatmentThe 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.
Outcome measures
| Measure |
Lee Silverman Voice Treatment
n=12 Participants
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.
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.
|
SpeechVive
n=12 Participants
Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
SpeechVive: Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
|
Control
n=10 Participants
Persons with Parkinsons disease do not receive voice intervention
Control: Persons assigned to the non-treatment control group will not participate in voice treatment.
|
|---|---|---|---|
|
Treatment-related Changes in Communicative Competence Will be Assessed Using the Communicative Participation Item Bank-Short Form Questionnaire
Baseline
|
19.17 score on a scale
Standard Deviation 5.98
|
16.09 score on a scale
Standard Deviation 7.99
|
18.3 score on a scale
Standard Deviation 4.95
|
|
Treatment-related Changes in Communicative Competence Will be Assessed Using the Communicative Participation Item Bank-Short Form Questionnaire
Post-treatment
|
23 score on a scale
Standard Deviation 4.81
|
16.45 score on a scale
Standard Deviation 6.12
|
18.78 score on a scale
Standard Deviation 8.48
|
SECONDARY outcome
Timeframe: Change from baseline after 8 weeks of treatmentThe Voice-related Quality of Life VR-QOL 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. The minimum total score is 10 and the maximum total score is 50. Higher scores indicate that the voice problem interferes with activities of daily living. The overall VR-QOL score ranges from 10 to 15 (excellent), 16 to 20 (very good), 21 to 25 (good), 26-30 (fair) and scores more than 30 and up to 50 is poor.
Outcome measures
| Measure |
Lee Silverman Voice Treatment
n=12 Participants
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.
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.
|
SpeechVive
n=12 Participants
Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
SpeechVive: Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
|
Control
n=10 Participants
Persons with Parkinsons disease do not receive voice intervention
Control: Persons assigned to the non-treatment control group will not participate in voice treatment.
|
|---|---|---|---|
|
Treatment-related Changes in Activities of Daily Living Assessed by the Voice-related Quality of Life (VR-QOL) Questionnaire
Baseline
|
19 score on a scale
Standard Deviation 7.83
|
23.91 score on a scale
Standard Deviation 9.09
|
25.1 score on a scale
Standard Deviation 6.37
|
|
Treatment-related Changes in Activities of Daily Living Assessed by the Voice-related Quality of Life (VR-QOL) Questionnaire
Post-treatment
|
16.13 score on a scale
Standard Deviation 5.19
|
21.27 score on a scale
Standard Deviation 5.98
|
21.33 score on a scale
Standard Deviation 7.73
|
SECONDARY outcome
Timeframe: Change from baseline after 8 weeks of treatmentPopulation: The primary goal was to ascertain the impact of internal cueing (SpeechVive) and external cueing (Lee Silverman Voice Treatment) on speech rate. To achieve this goal, and to ensure adequate statistical power was maintained, a direct treatment group comparison was undertaken. As a result, the clinical controls, who did not receive any form of intervention, were excluded from this analysis.
While wearing a microphone, participants will read a short passage. The 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 and lower values indicate a slower speech rate.
Outcome measures
| Measure |
Lee Silverman Voice Treatment
n=12 Participants
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.
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.
|
SpeechVive
n=12 Participants
Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
SpeechVive: Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
|
Control
Persons with Parkinsons disease do not receive voice intervention
Control: Persons assigned to the non-treatment control group will not participate in voice treatment.
|
|---|---|---|---|
|
Treatment-related Changes in Speech Rate Will be Assessed Using Acoustic Analysis.
Baseline
|
3.27 Syllables per second
Standard Deviation 0.93
|
3.53 Syllables per second
Standard Deviation 0.86
|
—
|
|
Treatment-related Changes in Speech Rate Will be Assessed Using Acoustic Analysis.
Post-treatment
|
3.26 Syllables per second
Standard Deviation 0.88
|
3.42 Syllables per second
Standard Deviation 1.02
|
—
|
SECONDARY outcome
Timeframe: Change from baseline after 8 weeks of treatmentWhile wearing a microphone, participants will read a short passage. These recorded speech samples will be analyzed for the frequency of pauses using an acoustic analysis software program. Pauses are reported as a frequency count (how many occur in a given sample).
Outcome measures
| Measure |
Lee Silverman Voice Treatment
n=12 Participants
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.
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.
|
SpeechVive
n=12 Participants
Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
SpeechVive: Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
|
Control
n=10 Participants
Persons with Parkinsons disease do not receive voice intervention
Control: Persons assigned to the non-treatment control group will not participate in voice treatment.
|
|---|---|---|---|
|
Treatment-related Changes in Speech Pauses Will be Assessed Using Acoustic Analysis.
Baseline
|
26 Pauses per sample
Standard Deviation 7.65
|
27.19 Pauses per sample
Standard Deviation 14.03
|
26.6 Pauses per sample
Standard Deviation 8.30
|
|
Treatment-related Changes in Speech Pauses Will be Assessed Using Acoustic Analysis.
Post-treatment
|
29.88 Pauses per sample
Standard Deviation 6.24
|
27.18 Pauses per sample
Standard Deviation 9.06
|
27.11 Pauses per sample
Standard Deviation 11.99
|
Adverse Events
Lee Silverman Voice Treatment
SpeechVive
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lee Silverman Voice Treatment
n=12 participants at risk
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.
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.
|
SpeechVive
n=12 participants at risk
Persons with Parkinson's disease receive eight weeks of voice treatment using the SpeechVive device.
SpeechVive: Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
|
Control
n=10 participants at risk
Persons with Parkinsons disease do not receive voice intervention
Control: Persons assigned to the non-treatment control group will not participate in voice treatment.
|
|---|---|---|---|
|
General disorders
Balance
|
0.00%
0/12 • 8 weeks
The study protocol involved non-invasive measures and did not put the subject at risk for a serious adverse event.
|
0.00%
0/12 • 8 weeks
The study protocol involved non-invasive measures and did not put the subject at risk for a serious adverse event.
|
10.0%
1/10 • Number of events 1 • 8 weeks
The study protocol involved non-invasive measures and did not put the subject at risk for a serious adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place