N/A
N=36
Voice Treatment for Parkinson's Disease
Idiopathic Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT03700684 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Treatment-related Changes in Vocal Intensity Will be Assessed Using Acoustic Analysis. — 3; 3; 0.26 Decibels
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lee Silverman Voice Treatment (Behavioral); SpeechVive (Device); Control (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Massachusetts, Amherst
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-related Changes in Vocal Intensity Will be Assessed Using Acoustic Analysis. |
3; 3; 0.26 | — |
| PRIMARY Treatment-related Changes in Speech Breathing Will be Assessed Using Respiratory Kinematics. |
22.89; 21.75; 17.87; 20.73; 5.84; 6.41 | — |
| PRIMARY Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (Open Quotient) |
0.72; 0.71; 0.72; 0.68 | — |
| PRIMARY Assessing Mental and Physical Effort Associated With Each Treatment Program Using the Modified National Aeronautics and Space Administration (NASA)-Task Load Index |
60.07; 35.23; 67.03; 16.59; 65.32; 22.31 | — |
| PRIMARY Treatment-related Changes in Speech Breathing Will be Assessed Using Laryngeal Aerodynamics (MFDR) |
194.31; 239.90; 179.53; 181.24 | — |
| SECONDARY Treatment-related Changes in Quality of Life Will be Assessed Using the Parkinson's Disease Questionnaire (PDQ-39) |
18.61; 23.04; 26.74; 18.13; 21.60; 23.95 | — |
| SECONDARY Treatment-related Changes in Communicative Competence Will be Assessed Using the Communicative Participation Item Bank-Short Form Questionnaire |
19.17; 16.09; 18.3; 23; 16.45; 18.78 | — |
| SECONDARY Treatment-related Changes in Activities of Daily Living Assessed by the Voice-related Quality of Life (VR-QOL) Questionnaire |
19; 23.91; 25.1; 16.13; 21.27; 21.33 | — |
| SECONDARY Treatment-related Changes in Speech Rate Will be Assessed Using Acoustic Analysis. |
3.27; 3.53; 3.26; 3.42 | — |
| SECONDARY Treatment-related Changes in Speech Pauses Will be Assessed Using Acoustic Analysis. |
26; 27.19; 26.6; 29.88; 27.18; 27.11 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03700684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.