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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018258
Receipt No. R000021130
Scientific Title NHO network research:TSPD as a rehabilitation program for Parkinson's disease
Date of disclosure of the study information 2015/07/13
Last modified on 2016/07/13

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Basic information
Public title NHO network research:TSPD as a rehabilitation program for Parkinson's disease
Acronym TSPD: Rehabilitation program
Scientific Title NHO network research:TSPD as a rehabilitation program for Parkinson's disease
Scientific Title:Acronym TSPD: Rehabilitation program
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy of TSPD (rehabilitation program for PD)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes MDS-UPDRS
Key secondary outcomes Hoehn-Yahr stage, posture, ability of walk, volume of voice, ROM, FIM, motor symptoms of PD, non-motor symptoms of PD, intellectual function(MMSE, FAB, SKAS), PDQ-39

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 TSPD-M
Interventions/Control_2 TSPD-A
Interventions/Control_3 nordic walk
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
90 years-old >
Gender Male and Female
Key inclusion criteria (1) Patient with PD diagnosed by Brain Bank Criteria for PD
(2) Patient with informed consent
Key exclusion criteria (1) in pregnancy, during lactation
(2) dysphagia, predictable prognosis such as respiratory failure, circulation failure, renal failure, hepatic failure
(3) depression requiring treatment
(4) patients with DBS or stereotaxic brain surgery
(5) cognitive disorder (MMSE<20)
(6) onset of age under 40 years
(7) not to indicate this program for the patient by attending physician
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name HASEGAWA, Kazuko
Organization National Hospital Organization, Sagamihara National Hospital
Division name Neurology
Zip code
Address 18-1 Sakuradai, Minami-ku, Sagamihara city, Kanagawa
TEL 042-742-8311
Email k-hasegawa@sagamihara-hosp.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name HASEGAWA, Kazuko
Organization National Hospital Organization, Sagamihara National Hospital
Division name Neurology
Zip code
Address 18-1 Sakuradai,Minami-ku, Sagamihara, Kanagawa
TEL 042-742-8311
Homepage URL http://www.hosp.go.jp/~sagami/
Email k-hasegawa@sagamihara-hosp.gr.jp

Sponsor
Institute Department of Neurology, National Hospital Organization, Sagamihara National Hospital
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
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 相模原病院,北海道医療センター,あきた病院,西多賀病院,鳥取医療センター,旭川医療センター,岩手病院,千葉東病院,新潟病院,西新潟中央病院,まつもと医療センター,静岡藤病院,刀根山病院,和歌山病院、東名古屋病院,松江医療センター,水戸医療センター,隈元南病院,長崎川だな医療センター,青森県立中央病院,旭川赤十字病院

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 13 Day

Related information
URL releasing protocol http://www.hosp.go.jp
Publication of results Partially published

Result
URL related to results and publications http://www.hosp.go.jp
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 Preinitiation
Date of protocol fixation
2015 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 07 Month 31 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 09 Day
Last modified on
2016 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021130

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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