UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018258
Receipt number 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 13:47:03

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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 or person

Institute

Department of Neurology, National Hospital Organization, Sagamihara National Hospital

Institute

Department

Personal name



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

Value
https://center6.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