UMIN-CTR Clinical Trial

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
Email

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
Email	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
Email

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
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

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