- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02506205
The Effect of LSVT LOUD for Mandarin-speaking Individuals With Hypokinetic Dysarthria Due to Parkinson's Disease
July 21, 2015 updated by: National Taiwan University Hospital
A handful of studies have examined the effects of the Lee Silverman Voice Treatment (LSVT) LOUD on hypokinetic dysarthria in English speakers with Parkinson's disease (PD).
Although LSVT LOUD has been found to be effective on improving these speaker's vocal intensity and increasing their speech intelligibility as well as speech function with Phase I evidence, no study has investigated whether Mandarin-speaking individuals with dysarthria secondary to PD would benefit from LSVT LOUD.
In the proposed study, speech data of Mandarin-speaking individuals with hypokinetic dysarthria before and after speech therapy will be audio recorded and analyzed in order to examine the effects of LSVT LOUD on the speech function in this population.
The same speech data will be played to Mandarin listeners in order to investigate the speech intelligibility of this population.
It is hypothesized that Mandarin-speaking individuals with hypokinetic dysarthria secondary to PD will demonstrate reduced vocal intensity, reduced speech intelligibility and impaired speech function before they receive LSVT LOUD.
They will improve these speech characteristics following speech therapy and will present with short-term maintenance effects.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Ruey-Meei Wu, Professor
- Phone Number: 2144 886-2-23123456
- Email: robinwu@ntu.edu.tw
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Contact:
- Wen-Chieh Yang, Ph.D. student
- Phone Number: 886-2-33668149
- Email: d98428003@ntu.edu.tw
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Principal Investigator:
- Ruey-Meei Wu, Professor
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Mandarin-speaking Taiwanese
- Hypokinetic dysarthria due to Parkinson's disease
- No other neurodegenerative diseases
- No cognitive deficits
- Age range 30 years and above
Exclusion Criteria:
- Not able to follow verbal directions,
- speech characteristics uncommon to Parkinson's disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LSVT LOUD
LSVT LOUD was developed based on concepts of neuroplasticity, motor learning, skill acquisition and motor speech.
LSVT LOUD trains laryngeal and respiratory functions through loud and effortful phonatory tasks (Ramig, Sapir, Countryman, Pawlas, O'Brien, Hoehn, & Thomson, 2001).
It targets vocal intensity via stimulation of effortful speech productions with multiple repetitions and through encouraging self-calibrations of loud voice by patients.
LSVT LOUD cues patients to speak loud (e.g., Fox et al., 2002; Ramig et al., 2001; Sapir et al., 2007).
Having a single cue may increase treatment effects, as it reduces cognitive load in adults with PD because some of them develop cognitive deficits when PD progresses (Fox et al., 2002).
Treatment is intensive, consisting of 4 individual sessions a week for 4 weeks, with 16 sessions in one month.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech intelligibility
Time Frame: Immediate
|
Speech intelligibility will be assessed by native Mandarin listeners' orthographic transcription accuracy and ratings based on a nine-point Likert scale (from 1 - very difficult to understand to 9 - very easy to understand).
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Immediate
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech function
Time Frame: Immdediate
|
Speech function will be assessed using acoustic methods.
E.g., vowel formant frequencies correlated with vowel articulation will be extracted and analyzed using Praat software.
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Immdediate
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life measured by PDQ-39
Time Frame: Immediate
|
This area of assessment will be measured by Parkinson's Disease Questionnaire (PDQ-39) (Jenkinson, Fitzpatrick, Peto, Greenhall, & Hyman, 1997).
This battery provides information on areas that affect participants' well-being and the degree affected.
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Immediate
|
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Depression level measured by BDI-II
Time Frame: Immediate
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Some patients with PD develop depression that affects their daily life.
Therefore, it is necessary to assess their depression level with Beck Depression Inventory-II (Beck, Steer, & Brown, 1996)
|
Immediate
|
|
Cognitive status measured by MMSE
Time Frame: Immediate
|
It is necessary to assess their cognitive status with Mini-mental State Examination (MMSE) (Folstein, Foistein, & McHugh, 1975) and the score will be used as the inclusion or exclusion criteria.
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Immediate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Darley FL, Aronson AE, Brown JR. Clusters of deviant speech dimensions in the dysarthrias. J Speech Hear Res. 1969 Sep;12(3):462-96. doi: 10.1044/jshr.1203.462. No abstract available.
- Fox, C. M., Morrison, C. E., Ramig, L. O., & Sapir, S. (2002). Current perspectives on the Lee Silverman Voice Treatment (LSVT) for individuals with idiopathic Parkinson disease. American Journal of Speech-Language Pathology, 11: 111-123.
- Jeng JY, Weismer G, Kent RD. Production and perception of mandarin tone in adults with cerebral palsy. Clin Linguist Phon. 2006 Jan-Feb;20(1):67-87. doi: 10.1080/02699200400016539.
- Liu, H.-M., Tseng, C.-H., & Tsao, F.-M. (2000). Perceptual and acoustic analysis of speech intelligibility in Mandarin-speaking young adults with cerebral palsy. Clinical Linguistics and Phonetics, 14: 447-464
- Ramig LO, Sapir S, Countryman S, Pawlas AA, O'Brien C, Hoehn M, Thompson LL. Intensive voice treatment (LSVT) for patients with Parkinson's disease: a 2 year follow up. J Neurol Neurosurg Psychiatry. 2001 Oct;71(4):493-8. doi: 10.1136/jnnp.71.4.493.
- Sapir S, Spielman JL, Ramig LO, Story BH, Fox C. Effects of intensive voice treatment (the Lee Silverman Voice Treatment [LSVT]) on vowel articulation in dysarthric individuals with idiopathic Parkinson disease: acoustic and perceptual findings. J Speech Lang Hear Res. 2007 Aug;50(4):899-912. doi: 10.1044/1092-4388(2007/064). Erratum In: J Speech Lang Hear Res. 2007 Dec;50(6):1652.
- Schulz GM, Grant MK. Effects of speech therapy and pharmacologic and surgical treatments on voice and speech in Parkinson's disease: a review of the literature. J Commun Disord. 2000 Jan-Feb;33(1):59-88. doi: 10.1016/s0021-9924(99)00025-8.
- Whitehill TL, Wong LL. Effect of intensive voice treatment on tone-language speakers with Parkinson's disease. Clin Linguist Phon. 2007 Nov-Dec;21(11-12):919-25. doi: 10.1080/02699200701602045.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
July 21, 2015
First Submitted That Met QC Criteria
July 21, 2015
First Posted (Estimate)
July 23, 2015
Study Record Updates
Last Update Posted (Estimate)
July 23, 2015
Last Update Submitted That Met QC Criteria
July 21, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201407035RINC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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