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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036223
Receipt No. R000041266
Scientific Title Effectiveness of Lee Silverman Voice Treatment LOUD in Japanese-speaking patients with Parkinson's disease
Date of disclosure of the study information 2019/03/18
Last modified on 2019/03/16

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Basic information
Public title Effectiveness of Lee Silverman Voice Treatment LOUD in Japanese-speaking patients with Parkinson's disease
Acronym Effectiveness of Lee Silverman Voice Treatment LOUD in Japanese-speaking patients with Parkinson's disease
Scientific Title Effectiveness of Lee Silverman Voice Treatment LOUD in Japanese-speaking patients with Parkinson's disease
Scientific Title:Acronym Effectiveness of Lee Silverman Voice Treatment LOUD in Japanese-speaking patients with Parkinson's disease
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Studies on LSVT LOUD have been conducted in a few other languages and have primarily focused on the analysis of acoustic parameters before and after treatment. The increase in conversational intelligibility in both English and Spanish dysarthria in PD patients following LSVT LOUD treatment could be explained by language-universal factors. In addition, LSVT for 4 weeks has been demonstrated to increase vocal loudness and improve intelligibility in Japanese-speaking PD patients: however, the long-term effects of LSVT have not been examined in these patients. Therefore, the present study examined the long-term effects of LSVT in Japanese-speaking PD patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The assessments described below were conducted at the following times: 1) pretreatment (Baseline), 2) immediately after four weeks of treatment, and 3) at the end of 12 months of follow-up (12FU) after four weeks of treatment.
1) Vocal loudness
A) Sustained phonation of /a/,B) Reading a passage: "The North Wind and the Sun" C) Delivering a monologue: This task used the Japanese folk tale "Momotaro".
Key secondary outcomes 2) Intelligibility
Intelligibility was assessed based on the reading of a passage and the production of a monologue recorded in vocal loudness testing. The audio samples were arranged randomly and assessed at a constant SPL by three speech-language pathologists with at least five years of experience. The audio data were copied and reassessed to examine the reproducibility of the original assessments. Intelligibility was assessed using a standard Japanese test, as described by Itoh et al. Audio samples were assessed on a nine-level scale in 0.5-point increment, including "1. Completely intelligible," "2. Some unintelligible words," "3. Intelligible if the listener knows the topic," "4. Few intelligible words," and "5. Completely unintelligible." Intraclass correlation coefficients (ICCs) were calculated to determine the assessor with the highest reliability; this assessor's assessments of intelligibility were used as reference values.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria LSVT LOUD training was conducted at our hospital from April 1, 2011 to March 31, 2020
Key exclusion criteria Person who is diagnosed with dementia
Target sample size 30

Research contact person
Name of lead principal investigator
1st name KEIGO
Middle name
Last name NAKAYAMA
Organization National Center Hospital,National Center of Neurology and Psychiatry
Division name Department of Rehabilitation Medicine,
Zip code 187-8551
Address 4-1-1 ogawahigashimachi, Kodaira, Tokyo, Japan
TEL +80-42-341-2711
Email stnakayama@ncnp.go.jp

Public contact
Name of contact person
1st name KEIGO
Middle name
Last name NAKAYAMA
Organization National Center Hospital, National Center of Neurology and Psychiatry
Division name Department of Rehabilitation Medicine
Zip code 187-8551
Address 4-1-1 ogawahigashimachi, Kodaira, Tokyo, Japan
TEL +80-42-341-2711
Homepage URL
Email stnakayama@ncnp.go.jp

Sponsor
Institute National Center Hospital,
National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB, National Center of Neurology and Psychiatry
Address 4-1-1 ogawahigashimachi, Kodaira, Tokyo, Japan
Tel +80-42-341-2711
Email rinri-jimu@ncnp.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 22
Results
Fourteen patients were followed-up till 12FU. The changes in dB SPL from baseline to immediately after treatment were +5.7 dB, +4.8 dB, and 4.1 dB, and those from baseline to the 12FU were +4.0 dB, +5.6 dB, and +4.9 dB for sustained phonation of /a/, reading a passage, and delivering a monologue, respectively. Despite significant variability at all assessment points, intelligibility significantly improved immediately after treatment, but not at 12FU, compared with baseline.
Results date posted
2019 Year 03 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study included 22 Japanese PD patients (14 men and 8 women; median age, 67.5 years [range, 63.5 - 69.8 years]; disease duration, 9.0 years [range, 4.3 - 12.8 years]; Modified Unified Parkinson's Disease Rating Scale, 34.5 [range, 21.8 - 47.0]; Hoehn & Yahr Scale stage, 3.0 [range, 2.0 - 3.0]; Raven's Colored Progressive Matrices score, 29.0 [range, 26.0 - 30.0]), and they underwent LSVT at our hospital between April 2011 and February 2018. All patients were clinically diagnosed with possible PD because they met the International Parkinson and Movement Disorder Society clinical diagnosis criteria. In addition, dopamine transporter single-photon emission coupled tomography revealed striatonigral degeneration, and metaiodobenzylguanidine myocardial scintigraphy found a reduced heart-to-mediastinum uptake ratio (delayed images) in all patients.Treatment with antiparkinsonian drugs improved motor symptoms in all patients.
Participant flow
Patients who requested LOUD were intensively trained for 4 weeks and followed up until 12 months.
Adverse events
None
Outcome measures
1) Vocalloudness
2) Intelligibility
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
2016 Year 06 Month 17 Day
Anticipated trial start date
2016 Year 06 Month 17 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information We retrospectively investigated voice volume and intelligibility for patients who received one month of training.

Management information
Registered date
2019 Year 03 Month 16 Day
Last modified on
2019 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041266

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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