UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053592 |
|---|---|
| Receipt number | R000061156 |
| Scientific Title | Monitoring Survey of Carbon Insoles for Individuals with Hemiplegia Due to Stroke |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/02/10 13:47:27 |
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Basic information
Public title
Monitoring Survey of Carbon Insoles for Individuals with Hemiplegia Due to Stroke
Acronym
Monitoring Survey of Carbon Insoles for Individuals with Hemiplegia Due to Stroke
Scientific Title
Monitoring Survey of Carbon Insoles for Individuals with Hemiplegia Due to Stroke
Scientific Title:Acronym
Monitoring Survey of Carbon Insoles for Individuals with Hemiplegia Due to Stroke
Region
| Japan |
Condition
Condition
Hemiplegia Due to Stroke
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the applicability of the carbon insole to physical therapists and to conduct an adherence study on hemiplegics with the aim of practical application.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
monitoring survey
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Carbon insol
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Hemiplegic stroke victim
(2) The patient must be able to walk unassisted.
(3) Must be using a ankle foot orthosis.
Key exclusion criteria
(1) Cases do not meet the selection criteria
(2) Cases with no intention to participate in the study
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | hirokazu |
| Middle name | |
| Last name | haruna |
Organization
Hokkaido University of Science
Division name
Department of Physical Therapy, Faculty of Health and Medical Sciences
Zip code
0068585
Address
4-1, Maeda 7jo 15-chome, Teinei-ku, Sapporo, Hokkaido
TEL
0116882204
haruna@hus.ac.jp
Public contact
Name of contact person
| 1st name | hirokazu |
| Middle name | |
| Last name | haruna |
Organization
Hokkaido University of Science
Division name
Department of Physical Therapy, Faculty of Health and Medical Sciences
Zip code
0068585
Address
4-1, Maeda 7jo 15-chome, Teinei-ku, Sapporo, Hokkaido
TEL
0116882204
Homepage URL
haruna@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
hirokazu haruna
Funding Source
Organization
Hokkaido University of 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
Hokkaido University of Science
Address
Department of Physical Therapy, Faculty of Health and Medical Sciences
Tel
0116882204
haruna@hus.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
北海道
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | 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
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 02 | Month | 10 | Day |
Last modified on
| 2024 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061156
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
