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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ruei-Meei Wu
  • Phone Number: 2144 886-2-2312345

Study Contact Backup

  • Name: Wen-Chieh Yang
  • Phone Number: 886-2-33668149

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ruey-Meei Wu, Professor

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Mandarin-speaking Taiwanese
  2. Hypokinetic dysarthria due to Parkinson's disease
  3. No other neurodegenerative diseases
  4. No cognitive deficits
  5. Age range 30 years and above

Exclusion Criteria:

  1. Not able to follow verbal directions,
  2. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Lee Silverman Voice Treatment (SVLT) LOUD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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).
Immediate

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Immdediate

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.
Immediate
Depression level measured by BDI-II
Time Frame: Immediate
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.
Immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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