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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025462
Receipt No. R000029303
Scientific Title Group-based multidisciplinary rehabilitation for Parkinson's disease: An in-patient approach
Date of disclosure of the study information 2016/12/28
Last modified on 2018/12/07

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Basic information
Public title Group-based multidisciplinary rehabilitation for Parkinson's disease: An in-patient approach
Acronym Group-based rehabilitation for Parkinson's disease
Scientific Title Group-based multidisciplinary rehabilitation for Parkinson's disease: An in-patient approach
Scientific Title:Acronym Group-based rehabilitation for Parkinson's disease
Region
Japan

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

Objectives
Narrative objectives1 We assessed the effect of group-based multidisciplinary rehabilitation for Parkinson's disease.
Basic objectives2 Others
Basic objectives -Others 1-year follow-up
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes UPDRS parts 1-4
Key secondary outcomes MMSE, FAB, SDS

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Group-based multidisciplinary rehabilitation for in-patients with Parkinson's disease for 5 weeks
Interventions/Control_2 Individual-based multidisciplinary rehabilitation for in-patients with Parkinson's disease for 5 weeks
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
50 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Eligibility criteria included a clinical diagnosis of PD with a disease severity rating of stage 3 to 4 on the Hoehn and Yahr scale,stable medication use, medical clearance for participation, and willingness to participate in treatment and outcome testing.
Key exclusion criteria Exclusion criteria were current participation in any other behavioral or pharmacologic study or debilitating conditions that would impede full participation.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Mitsui
Organization Tokushima National Hospital, National Hospital Organization
Division name Department of Clinical Research
Zip code
Address 1354 Shikiji, Kamojima, Yoshinogawa, Tokushima 776-0031 Japan
TEL 0883-24-2161
Email tmitsui@tokushima-nh.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Arisa Shimizu
Organization Tokushima National Hospital, National Hospital Organization
Division name Department of Clinical Research
Zip code
Address 1354 Shikiji, Kamojima, Yoshinogawa, Tokushima 776-0031 Japan
TEL 0883-24-2161
Homepage URL
Email rinsyou@tokushima-nh.hosp.go.jp

Sponsor
Institute Department of Clinical Research, Tokushima National Hospital, National Hospital Organization
Institute
Department

Funding Source
Organization JPS
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 28 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 Open public recruiting
Date of protocol fixation
2014 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 28 Day
Last modified on
2018 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029303

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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