UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054542 |
|---|---|
| Receipt number | R000062310 |
| Scientific Title | Effect of pelvic floor muscle training on Parkinson's disease |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/06/01 13:53:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of pelvic floor muscle training on Parkinson's disease
Acronym
Effect of pelvic floor muscle training on Parkinson's disease
Scientific Title
Effect of pelvic floor muscle training on Parkinson's disease
Scientific Title:Acronym
Effect of pelvic floor muscle training on Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease patients
Classification by specialty
| Neurology | Urology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In addition to quantitatively measuring pelvic floor muscle training using transabdominal ultrasound, we will also measure posture and investigate the relationship with lower urinary tract symptoms to examine the effectiveness of pelvic floor muscle training from multiple angles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At the time of intervention and at the end of the intervention, ultrasound examinations, posture evaluations, lower urinary tract symptoms, bowel symptoms, and QOL will be investigated.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Pelvic floor muscle training
Interventions/Control_2
Kotsuban soko-kin kunren o shinai
11 / 5,000
Not doing pelvic floor muscle training
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Parkinson's disease severity classification: Grade 3 or less
Key exclusion criteria
Parkinson's disease severity classification: Grade 4 or higher
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sshoko |
| Middle name | |
| Last name | hayashida |
Organization
Kansai University of Social Welfare
Division name
Faculty of Nursing
Zip code
6780255
Address
380-3 Nitta, Ako City, Hyogo Prefecture
TEL
0791462525
hayashida@kusw.ac.jp
Public contact
Name of contact person
| 1st name | shoko |
| Middle name | |
| Last name | hayashida |
Organization
Kansai University of Social Welfare
Division name
Faculty of Nursing
Zip code
67802355
Address
380-3 Nitta, Ako City, Hyogo Prefecture
TEL
0791462525
Homepage URL
hayashida@kusw.ac.jp
Sponsor or person
Institute
Kansai University of Social Welfare
Institute
Department
Personal name
Funding Source
Organization
Kansai University of Social Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai University of Social Welfare
Address
380-3 Nitta, Ako City, Hyogo Prefecture
Tel
0791462525
hayashida@kusw.ac.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
| 2024 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 01 | Day |
Last modified on
| 2024 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062310
