UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050524 |
|---|---|
| Receipt number | R000057536 |
| Scientific Title | The effects of Lee Silverman Voice Treatment (LSVT) BIG on cognitive functions among people with Parkinson's disease |
| Date of disclosure of the study information | 2023/03/07 |
| Last modified on | 2025/03/08 09:21:51 |
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Basic information
Public title
The effects of Lee Silverman Voice Treatment (LSVT) BIG on cognitive functions among people with Parkinson's disease
Acronym
The effects of Lee Silverman Voice Treatment (LSVT) BIG on cognitive functions among people with Parkinson's disease
Scientific Title
The effects of Lee Silverman Voice Treatment (LSVT) BIG on cognitive functions among people with Parkinson's disease
Scientific Title:Acronym
The effects of Lee Silverman Voice Treatment (LSVT) BIG on cognitive functions among people with Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to reveal the effects of LSVT BIG on cognitive functions among people with Parkinson's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mini mental state examination
The Japanese version of Montreal cognitive assessment
frontal assessment battery
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
people with Parkinson's disease who were admitted to Kakeyu Hospital
Key exclusion criteria
people with other neurological diseases
medication adjustment during LSVT BIG
requests of deregistration from individuals with Parkinson's disease or their family
people who fail to complete LSVT BIG
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keita |
| Middle name | |
| Last name | Sue |
Organization
JA Nagano Kouseiren Kakeyu Misayama Rehabilitation center Kakeyu Hospital
Division name
Department of Rehabilitation
Zip code
386-0396
Address
1308, Kakeyuonsen, Ueda, Nagano, Japan
TEL
0268-44-2111
keitasue@live.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Sue |
Organization
JA Nagano Kouseiren Kakeyu Misayama Rehabilitation center Kakeyu Hospital
Division name
Department of Rehabilitation
Zip code
386-0396
Address
1308, Kakeyuonsen, Ueda, Nagano, Japan
TEL
0268-44-2111
Homepage URL
keitasue@live.jp
Sponsor or person
Institute
Keita Sue
Department of Rehabilitation, Kakeyu Misayama Rehabilitation center Kakeyu Hospital
Institute
Department
Personal name
Funding Source
Organization
Keita Sue
Department of Rehabilitation, Kakeyu Misayama Rehabilitation center Kakeyu Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JA Nagano Kouseiren Kakeyu Misayama Rehabilitation center Kakeyu Hospital
Address
1308, Kakeyuonsen, Ueda, Nagano, Japan
Tel
0268-44-2111
keitasue@live.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
JA長野厚生連鹿教湯三才山リハビリテーションセンター鹿教湯病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 07 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2027 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2027 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2029 | Year | 11 | Month | 01 | Day |
Other
Other related information
In group comparison of cognitive tests between before and after LSVT BIG.
To determine what factor influences the improvement of cognitive function.
Management information
Registered date
| 2023 | Year | 03 | Month | 07 | Day |
Last modified on
| 2025 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057536
