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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000021636
Receipt No. R000024952
Scientific Title The effects of the hot compress to the back for sensitivity to cold of patients with Parkinson's disease
Date of disclosure of the study information 2016/03/27
Last modified on 2017/04/10

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Basic information
Public title The effects of the hot compress to the back for sensitivity to cold of patients with Parkinson's disease
Acronym The hot compress to the back for sensitivity to cold of patients with Parkinson's disease
Scientific Title The effects of the hot compress to the back for sensitivity to cold of patients with Parkinson's disease
Scientific Title:Acronym 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
1st name
Middle name
Last name Midori Tsukagoshi
Organization Yokohama City University
Division name School of Nursing
Zip code
Address 3-9 Fukuura Kanazawa-ku, Yokohama city
TEL 045-787-2525
Email mtsu@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Midori Tsukagoshi
Organization Yokohama City University
Division name School of Nursing
Zip code
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)

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 03 Month 27 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
Date of protocol fixation
2016 Year 03 Month 27 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000024952

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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