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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000005097 |
Receipt No. | R000006055 |
Scientific Title | An effect of the exercise training for the Parkinson's disease |
Date of disclosure of the study information | 2011/02/16 |
Last modified on | 2011/02/23 |
Basic information | ||
Public title | An effect of the exercise training for the Parkinson's disease | |
Acronym | An effect of the exercise training for the Parkinson's disease | |
Scientific Title | An effect of the exercise training for the Parkinson's disease | |
Scientific Title:Acronym | An effect of the exercise training for the Parkinson's disease | |
Region |
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Condition | ||||
Condition | Parkinson's disease | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | We comfirm whether the training for the posture abnormality of the Parkinson's disease patient are effective or not.
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Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | The amount of change of the angle of neck dropping and lumber curvature (comptocormia) |
Key secondary outcomes | The amount of change of the speed of the finger movement |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -but assessor(s) are blinded |
Control | No treatment |
Stratification | NO |
Dynamic allocation | YES |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Educational,Counseling,Training | |
Type of intervention |
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Interventions/Control_1 | Paraspinal muscle training | |
Interventions/Control_2 | Finger movement 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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | The Parkinson's disease patient who can training with the posture abnormality (the neck dropping and/or camptocormia) | |||
Key exclusion criteria | The patient who cannot training because of the severe spinal column and finger deformity, severe internal organs disease and so on | |||
Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Jichi Medical University | ||||||
Division name | Department of Neurology | ||||||
Zip code | |||||||
Address | 3311-1 Yakushiji Shimotsuke City Tochigi pref. JAPAN | ||||||
TEL | 0285-58-7352 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Jichi Medical University | ||||||
Division name | Department of Neurology | ||||||
Zip code | |||||||
Address | 3311-1 Yakushiji Shimotsuke City Tochigi pref. JAPAN | ||||||
TEL | 0285-58-7352 | ||||||
Homepage URL | |||||||
yacht-po@jichi.ac.jp |
Sponsor | |
Institute | Jichi Medical University, Department of Neurology |
Institute | |
Department |
Funding Source | |
Organization | The research committee on the neurodegenerative diseases |
Organization | |
Division | |
Category of Funding Organization | |
Nationality of Funding Organization | Japan |
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 | 自治医科大学附属病院、国立精神神経医療研究センター、北里大学病院、北里大学東病院、埼玉県総合リハビリテーションセンター、静岡てんかん神経医療センター、東海大学医学部付属病院、岐阜大学医学部附属病院、山梨大学医学部附属病院、沼津リハビリテーション病院、岡山旭東病院、横浜神経内科・内科クリニック、富山大学附属病院、和歌山県立医科大学附属病院、筑波技術大学東西医学統合医療センター |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006055 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |