UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Group-based multidisciplinary rehabilitation for Parkinson's disease: An in-patient approach
Title of the study (Brief title)	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	Takao Mitsui
Organization	Tokushima National Hospital, National Hospital Organization
Division name	Department of Clinical Research
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	Arisa Shimizu
Organization	Tokushima National Hospital, National Hospital Organization
Division name	Department of Clinical Research
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 04 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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