UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of the hot compress to the back for sensitivity to cold of patients with Parkinson's disease
Title of the study (Brief title)	The hot compress to the back for sensitivity to cold of patients with Parkinson's disease
Region	Japan

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

Objectives
Narrative objectives1	Study for the hot compress to the back to the sensitivity to cold of patients with Parkinson's disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of the skin temperature of hands and feet before and after the hot compress
Key secondary outcomes	change of the sensitivity to cold (VAS) hardness of dorsal muscle vital signs

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	10 minitues the hot compress
Interventions/Control_2
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	sensitivity to cold in patients with Parkinson's disease patient with Hoehn-Yahr stage 1-4
Key exclusion criteria	1) patient with Hoehn-Yahr stage 5 2) patient with difficultly communication 3) patient with less than 90mmHg or more than 140 mmHg of systolic blood pressure,patient with less than 50 mmHg or more than 90mmHg of diastolic blood pressure 4) patient with sensitization of the skin
Target sample size	25

Research contact person
Name of lead principal investigator	Midori Tsukagoshi
Organization	Yokohama City University
Division name	School of Nursing
Address	3-9 Fukuura Kanazawa-ku, Yokohama city
TEL	045-787-2525
Email	mtsu@yokohama-cu.ac.jp

Public contact
Name of contact person	Midori Tsukagoshi
Organization	Yokohama City University
Division name	School of Nursing
Address	3-9 Fukuura Kanazawa-ku, Yokohama city
TEL	045-787-2525
Homepage URL
Email	mtsu@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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 03 Month 27 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 03 Month 27 Day
Anticipated trial start date	2016 Year 03 Month 27 Day
Last follow-up date
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 03 Month 27 Day
Last modified on	2017 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024952