UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051980 |
|---|---|
| Receipt number | R000059324 |
| Scientific Title | Examine the effects of Shabon Wrapping on stroke patients with pain and numbness in their lower limbs |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2023/08/23 04:11:03 |
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Basic information
Public title
Effectiveness of cleaning method using foam wrapping for stroke patients with foot pain and numbress
Acronym
Examination of the Effect of Washing Methods Wrapped in Form on Pain and Numbness
Scientific Title
Examine the effects of Shabon Wrapping on stroke patients with pain and numbness in their lower limbs
Scientific Title:Acronym
Examination of the Effect of Shabon Wrapping on Pain and Numbness
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study on the effect of Shabon Wrapping on patients with pain and numbness in lower extremities as aftereffects of stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in VAS immediately prior to and after the initial implementation before and after the intervention of Shabon Wrapping and 6-7days
Key secondary outcomes
1.Changes before and after the first day of VAS in the shabon wrapping group,around 3-4days later,and around 6-7days later
2.Changes before and after the first day of VAS in the shabon wrapping group,around 3-4days later,and6-7days later
3.EQ-5D
4.blood pressure pulse
5.patient satisfaction
6.adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Duration of intervention is up to 7days
Wipe ones lower limbs with a warm towel every day
The soap bubble wrap is done for 10 minutes
The soap bubble wrap will be carried out 3 times the first day, 3 to 4 days later, and 6 to 7 days later
Interventions/Control_2
Duration of intervention is up to 7days
Wipe ones lower limbs with a warm towel every day
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A person diagnosed with stroke
A person who is not conscious or cognitively affected by stroke and a person over 20 years of age who has pain and numbness confined to the paralyzed side
A person have the ability to agree
Key exclusion criteria
A patient whose mental and physical functions have deteriorated significantly after a medical professional researcher has conducted visual examinations and interviews, making it difficult to answer a questionnaire survey
A patient with chronic pain and numbness
A patient with pain and numbness on both sides
A patient with a history of allergies to soap and detergents and a rash on the lower extremities
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Miki |
| Middle name | |
| Last name | Matsumoto |
Organization
Fukuoka university chikushi hospital
Division name
Stroke center
Zip code
8180067
Address
Fukuokakenn chikushinosi zokumyouin 1-1-1
TEL
0929211011
chikushi@adm.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Fukuoka university chikushi hospital
Division name
Stroke center
Zip code
8180067
Address
Fukuokakenn chikushinoshi zokumyouin 1-1-1
TEL
0929211011
Homepage URL
yamamegu@adm.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka university
Institute
Department
Personal name
Funding Source
Organization
Fukuoka university
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
Fukuoka university medical faculty Department of Bioethics and Medical Ethics Committee on Medical Ethics
Address
Fukuokakenn fukuokashi jounannku nanakuma 7-45-1
Tel
0928011011
fumed-ethics@fukuoka-u.ac.jp
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
福岡大学筑紫病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 23 | Day |
Last modified on
| 2023 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059324
