UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021636 |
|---|---|
| Receipt number | 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 08:12:22 |
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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
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
mtsu@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024952
