UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005097 |
|---|---|
| Receipt number | 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 16:42:06 |
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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
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
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.
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
| Behavior,custom |
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
| Not applicable |
Age-upper limit
| Not applicable |
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
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Fujimoto |
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
| 1st name | |
| Middle name | |
| Last name | Yoshihito Ando |
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 or person
Institute
Jichi Medical University, Department of Neurology
Institute
Department
Personal name
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
| 2011 | Year | 02 | Month | 16 | 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
| 2010 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 16 | Day |
Last modified on
| 2011 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006055
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| Registered date | File name |
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| Registered date | File name |
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