UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028556 |
|---|---|
| Receipt number | R000032682 |
| Scientific Title | A comparison of Verbal Communication effects of hand-bathing with foot bath for stroke patients |
| Date of disclosure of the study information | 2017/08/20 |
| Last modified on | 2019/10/30 19:38:12 |
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Basic information
Public title
A comparison of Verbal Communication effects of hand-bathing with foot bath for stroke patients
Acronym
A comparison of Verbal Communication effects of hand-bathing with foot bath for stroke patients
Scientific Title
A comparison of Verbal Communication effects of hand-bathing with foot bath for stroke patients
Scientific Title:Acronym
A comparison of Verbal Communication effects of hand-bathing with foot bath for stroke patients
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate and compare the Verbal Communication effects of hand-bathing with foot bath for
stroke patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Morphological analysis of nouns during speech
Key secondary outcomes
Skin surface temperature
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Hand-bathing
Interventions/Control_2
Foot bath
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Adult stroke patient
2.Consciousness:Assessed by the ward manager
to have ability to answer questions on the
questionnaire (equivalent to scores of 15
or more in the Glasgow Coma Scale)
3.Brunnstrum stage V or below
4.Linguistic communication:Having ability to
communicate verbally
Key exclusion criteria
Potential participants were excluded if the target area demonstrated swelling, redness, rashes, wounds and itchy sensation.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rika Yano |
Organization
Hokkaido University
Division name
Faculty oh Health Sciences
Zip code
Address
Kita12, Nishi 5, Kita-ku, Sapporo
TEL
011-706-3323
r-yano@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rika Yano |
Organization
Hokkaido University
Division name
Faculty oh Health Sciences
Zip code
Address
Kita12, Nishi 5, Kita-ku, Sapporo
TEL
011-706-3323
Homepage URL
r-yano@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion on science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2017 | Year | 08 | Month | 20 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 06 | Day |
Last modified on
| 2019 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032682
