UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of Parkinson's disease rehabilitation using tai chi
Title of the study (Brief title)	Parkinson's disease rehabilitation using tai chi
Region	Japan

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

Objectives
Narrative objectives1	Assessment of effectiveness of the rehabilitation for Parkinson's disease using tai chi
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

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

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	tai chi plus regular rehabilitation
Interventions/Control_2	regular rehabilitation
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	40 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Parkinson's disease, Hoehn-Yahr stage 3-4 2)inpatient
Key exclusion criteria	Parkinson's disease, Hoehn-Yahr stage 1 or 5
Target sample size	500

Research contact person
Name of lead principal investigator	Takao Mitsui
Organization	Tokushima National Hospital
Division name	Department of Clinical Research
Address	1354 Shikiji, Kamojima, Yoshinogawa, Tokushima 776-0031, Japan
TEL	+81-883-24-2161
Email	tmitsui@tokushima-nh.hosp.go.jp

Public contact
Name of contact person	Sayaka Miyake
Organization	Tokushima National Hospital
Division name	Department of Clinical Research
Address	1354 Shikiji, Kamojima, Yoshinogawa, Tokushima 776-0031, Japan
TEL	+81-883-24-2161
Homepage URL
Email	rinsyou@tokushima-nh.hosp.go.jp

Sponsor
Institute	Tokushima National Hospital
Institute
Department

Funding Source
Organization	Tokushima National Hospital
Organization
Division
Category of Funding Organization	Government offices of other countries
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	2014 Year 12 Month 05 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 03 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 12 Month 04 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=R000018440