UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of inpatient rehabilitation for stooped posture with Parkinson's disease
Title of the study (Brief title)	Rehabilitation for stooped posture with Parkinson's disease
Region	Japan

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

Objectives
Narrative objectives1	Assessment of the effectiveness of inpatient rehabilitation for stooped posture with Parkinson's disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Trunk flexion angle
Key secondary outcomes	UPDRS,FIM,PDQ-39,BBS,TUG,VAS

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is 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	outpatient rehabilitation
Interventions/Control_2	inpatient rehabiliotation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Parkinson's disease patient with stooped posture
Key exclusion criteria	MMSE score < 23 point,Spinal deformity
Target sample size	20

Research contact person
Name of lead principal investigator	Yuki Kawami
Organization	Hyogo Prefectural Rehabilitation Hospital at Nishi-Harima
Division name	Department of Physical Therapy,Faculty of Rehabilitation
Address	7-1 Koto 1-chome,Shingu-cho,Tatsuno-shi,Hyogo 679-5165,Japan
TEL	0791-58-1050
Email	ykawami-hyogo@umin.ac.jp

Public contact
Name of contact person	Yuki Kawami
Organization	Hyogo Prefectural Rehabilitation Hospital at Nishi-Harima
Division name	Department of Physical Therapy,Faculty of Rehabilitation
Address	7-1 Koto 1-chome,Shingu-cho,Tatsuno-shi,Hyogo 679-5165,Japan
TEL	0791-58-1050
Homepage URL
Email	ykawami-hyogo@umin.ac.jp

Sponsor
Institute	Hyogo Prefectural Rehabilitation Hospital at Nishi-Harima
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Hyogo Prefectural Rehabilitation Hospital at Nishi-Harima
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kobe University Graduate School of Health Sciences
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 04 Month 07 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 07 Month 01 Day
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
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	2016 Year 04 Month 06 Day
Last modified on	2016 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025031