UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015846 |
|---|---|
| Receipt number | R000018440 |
| Scientific Title | The effectiveness of Parkinson's disease rehabilitation using tai chi |
| Date of disclosure of the study information | 2014/12/05 |
| Last modified on | 2018/12/07 14:09:53 |
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Basic information
Public title
The effectiveness of Parkinson's disease rehabilitation using tai chi
Acronym
Parkinson's disease rehabilitation using tai chi
Scientific Title
The effectiveness of Parkinson's disease rehabilitation using tai chi
Scientific Title:Acronym
Parkinson's disease rehabilitation using tai chi
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of effectiveness of the rehabilitation for Parkinson's disease using tai chi
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
UPDRS parts 1 to 4
Key secondary outcomes
MMSE, FAB and SDS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
tai chi plus regular rehabilitation
Interventions/Control_2
regular rehabilitation
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Parkinson's disease, Hoehn-Yahr stage 3-4
2)inpatient
Key exclusion criteria
Parkinson's disease, Hoehn-Yahr stage 1 or 5
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Mitsui |
Organization
Tokushima National Hospital
Division name
Department of Clinical Research
Zip code
Address
1354 Shikiji, Kamojima, Yoshinogawa, Tokushima 776-0031, Japan
TEL
+81-883-24-2161
tmitsui@tokushima-nh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayaka Miyake |
Organization
Tokushima National Hospital
Division name
Department of Clinical Research
Zip code
Address
1354 Shikiji, Kamojima, Yoshinogawa, Tokushima 776-0031, Japan
TEL
+81-883-24-2161
Homepage URL
rinsyou@tokushima-nh.hosp.go.jp
Sponsor or person
Institute
Tokushima National Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima National Hospital
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 12 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 04 | Day |
Last modified on
| 2018 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018440
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
