UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059698 |
|---|---|
| Receipt number | R000062978 |
| Scientific Title | Observation of the therapeutic effects of rehabilitation and lidocaine injections on postural abnormalities in Parkinson's disease and related disorders |
| Date of disclosure of the study information | 2025/11/08 |
| Last modified on | 2025/11/08 14:48:36 |
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Basic information
Public title
Observation of the therapeutic effects of rehabilitation and lidocaine injections on postural abnormalities in Parkinson's disease and related disorders
Acronym
Treatment of postural abnormalities with rehabilitation and lidocaine injections
Scientific Title
Observation of the therapeutic effects of rehabilitation and lidocaine injections on postural abnormalities in Parkinson's disease and related disorders
Scientific Title:Acronym
Treatment of postural abnormalities with rehabilitation and lidocaine injections
Region
| Japan |
Condition
Condition
Parkinson's disease and related disorders
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the therapeutic effects of rehabilitation and lidocaine injections performed at NCNP on postural abnormalities in Parkinson's disease and related diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improve posture in standing position
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients of Parkinson's disease-related disorders with postural abnormalities
2) Patients who have received or will receive treatment for postural abnormalities at our hospital
3) Those who are able to maintain a standing position
4) Those who have received an explanation of this study, understood its purpose, and agreed to participate
5) Those who have been treated for postural abnormalities for more than 6 months
Key exclusion criteria
1) Those who cannot maintain an upright position
2) Others who the principal investigator deems inappropriate
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Mukai |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of neurology
Zip code
187-8551
Address
4-1-1 Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
TEL
+81-42-341-2711
ymukai@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Mukai |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of neurology
Zip code
187-8551
Address
4-1-1 Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
TEL
+81-42-341-2711
Homepage URL
ymukai@ncnp.go.jp
Sponsor or person
Institute
National Research and Development Agency
Institute
Department
Personal name
Funding Source
Organization
National Research and Development Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of NCNP
Address
4-1-1, Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
Tel
+81-42-341-2712
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
| 2025 | Year | 11 | Month | 08 | 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
180
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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing to note
Management information
Registered date
| 2025 | Year | 11 | Month | 08 | Day |
Last modified on
| 2025 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062978
