UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040327 |
|---|---|
| Receipt number | R000046015 |
| Scientific Title | Effects of local cooling on skin blood flow response in persons with spinal cord injuries |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2020/05/08 04:36:17 |
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Basic information
Public title
Effects of local cooling on skin blood flow response in persons with spinal cord injuries
Acronym
Cold-induced cutaneous vasodilation in SCI
Scientific Title
Effects of local cooling on skin blood flow response in persons with spinal cord injuries
Scientific Title:Acronym
Cold-induced cutaneous vasodilation in SCI
Region
| Japan |
Condition
Condition
Cervical, thoracic, and lumbar spinal cord injuries
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess whether cold-induced cutaneous vasodilation, which is observed during cold water immersion of fingertips in able-bodies, occur even in a non-sensate area for spinal cord injuries and what temperature and how many minutes will need to induce the response.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A number of participants who will get a cold-induced cutaneous vasodilation (CIVD).
Key secondary outcomes
A delay, time constant, and maximal amplitude of a CIVD curve
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
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Local cooling at 15 and 8 degrees for 15 min of each
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons with spinal cord injuries C5-L2.
AIS A
Persons who can communicate
Persons who wish to participate the present study voluntarily
Persons without diabetes mellitus, hypertension, abnormal lipid metabolism
Persons who have been injured for more than 6 months
Key exclusion criteria
Persons affected by the followings:
inflammatory cutaneous disease
infection at the measurement
arteriosclerosis obliterans
collargen disease
liver disease
skin atrophy
aging over 65 y.o.
receiving steroid treatment
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Yoshi-ichiro |
| Middle name | |
| Last name | Kamijo |
Organization
Wakayama Medical University
Division name
Department of Rehabilitaion Medicine
Zip code
641-8509
Address
811-1 Kimidera
TEL
0734410664
yoshikmj@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshi-ichiro |
| Middle name | |
| Last name | Kamijo |
Organization
Wakayama Medical University
Division name
Department of Rehabilitaion Medicine
Zip code
641-8509
Address
811-1 Kimidera
TEL
0734410664
Homepage URL
yoshikmj@wakayama-med.ac.jp
Sponsor or person
Institute
Department of Rehabilitaion Medicine,
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Rehabilitaion Medicine,
Wakayama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama 641-8509, Japan
Tel
073-447-2300 ext.3692, 3693
wa-rinri@wakayama-med.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | 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
| 2020 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2020 | Year | 05 | Month | 08 | Day |
Last modified on
| 2020 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046015
