Hypokinetic DysathriaNCT02506205
The Effect of LSVT LOUD for Mandarin-speaking Individuals With Hypokinetic Dysarthria Due to Parkinson's Disease
A study testing Lee Silverman Voice Treatment (SVLT) LOUD in people with Hypokinetic Dysathria, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hypokinetic Dysathria
- What is being tested?
- Lee Silverman Voice Treatment (SVLT) LOUD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mandarin-speaking Taiwanese
- Hypokinetic dysarthria due to Parkinson's disease
- No other neurodegenerative diseases
- No cognitive deficits
- Age range 30 years and above
Who cannot join
- Not able to follow verbal directions,
- speech characteristics uncommon to Parkinson's disease
Trial locations and contacts
1 site in 1 country.
Ruei-Meei Wu contact
Wen-Chieh Yang contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Ruey-Meei Wu, Professor, 886-2-23123456 ext. 2144, robinwu@ntu.edu.tw
Wen-Chieh Yang, Ph.D. student, 886-2-33668149, d98428003@ntu.edu.tw
About this study
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.
- Conditions
- Hypokinetic Dysathria
- Being tested
- Lee Silverman Voice Treatment (SVLT) LOUD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lee Silverman Voice Treatment (SVLT) LOUDBehavioural
| Study group | Role | What they receive |
|---|---|---|
| LSVT LOUD | Experimental | 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. Receives: Behavioral: Lee Silverman Voice Treatment (SVLT) LOUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech intelligibility
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).
Measured: Immediate
Secondary outcomes (1)
Speech function
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.
Measured: Immdediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hypokinetic DysathriaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506205
- Sponsor's protocol ID
- 201407035RINC
- Status last verified
- Jul 2015
- First submitted
- 21 Jul 2015
- Last updated
- 23 Jul 2015
- Results posted
- No
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.
PubMed 5811846Fox, 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.
PubMed 16393799Liu, 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.
PubMed 11561033Sapir 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).
PubMed 17675595Schulz 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.
PubMed 10665513Whitehill 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.
PubMed 17972188
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of LSVT LOUD for Mandarin-speaking Individuals With Hypokinetic Dysarthria Due to Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02506205
- Acronym / sponsor ID
- 201407035RINC
- Conditions
- Hypokinetic Dysathria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LSVT LOUD | Experimental | Behavioral: Lee Silverman Voice Treatment (SVLT) LOUDLSVT 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mandarin-speaking Taiwanese
- Hypokinetic dysarthria due to Parkinson's disease
- No other neurodegenerative diseases
- No cognitive deficits
- Age range 30 years and above
Key exclusion criteria (2 listed)
- Not able to follow verbal directions,
- speech characteristics uncommon to Parkinson's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lee Silverman Voice Treatment (SVLT) LOUD | Behavioural | LSVT LOUD |
Primary outcome
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).
1 secondary outcome
Speech function
Time frame: Immdediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- Background: PubMed 5811846Darley 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.
- BackgroundFox, 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.
- Background: PubMed 16393799Jeng 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.
- BackgroundLiu, 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
- Background: PubMed 11561033Ramig 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.
- Background: PubMed 17675595Sapir 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).
- Background: PubMed 10665513Schulz 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.
- Background: PubMed 17972188Whitehill 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruei-Meei Wu contact
Wen-Chieh Yang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lee Silverman Voice Treatment (SVLT) LOUD in people with Hypokinetic Dysathria, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruei-Meei Wu (886-2-2312345 ext. 2144), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech intelligibility (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02506205, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.