UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028976 |
|---|---|
| Receipt number | R000033152 |
| Scientific Title | Multicenter nonrandomized single group of taping study about the effect to the finger for stroke patients. |
| Date of disclosure of the study information | 2017/09/04 |
| Last modified on | 2017/09/03 07:32:45 |
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Basic information
Public title
Multicenter nonrandomized single group of taping study about the effect to the finger for stroke patients.
Acronym
Effect of the taping to a finger on stroke patients.
Scientific Title
Multicenter nonrandomized single group of taping study about the effect to the finger for stroke patients.
Scientific Title:Acronym
Effect of the taping to a finger on stroke patients.
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We test the effect that we taped on a finger for stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Simple test for evaluating hand function:STEF
Key secondary outcomes
Active Range of motion.
Extension of MP joint, PIP joint, DIP joint of a thumb, a forefinger, the middle finger.
Hearing of "to stretch it out stake" which "do not change" which "it is easy to lengthen" after pasting in comparison with before pasting.
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
Treatment
Type of intervention
| Device,equipment | Maneuver | Other |
Interventions/Control_1
We tape it to a thumb and a forefinger and a middle finger.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The stroke hemiplegic patients who are admitted to an acute phase and the convalescent ward.
More than an STEF one point.
Twelve phase of ueda style single paralysis function tests.
More than arms function grade 3.
More than finger function grade 2.
There are not remarkable joint excursion restrictions.
The patients who a researcher explained study contents and signed consent form.
Key exclusion criteria
Lower than Mini-Mental State Examination 23 points.
Lower than Hasegawa's Dementia Scale for Revised 20 points.
Disturbance of consciousness Japan Coma Scale one point or more.
There is anosognosia.
There is eczema, dermatitis, itching in taping.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Hayashi |
Organization
Ebina neurosurgery
Division name
Outpatient rehabilitation
Zip code
Address
4-2-14, Shimoimaizumi, Ebina-shi, Kanagawa, 243-0435, Japan
TEL
046-236-2170
reha2004ot32@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Hayashi |
Organization
Ebina neurosurgery
Division name
Outpatient rehabilitation
Zip code
Address
4-2-14, Shimoimaizumi, Ebina-shi, Kanagawa, 243-0435, Japan
TEL
046-236-2170
Homepage URL
reha2004ot32@hotmail.com
Sponsor or person
Institute
Ebina neurosurgery
Institute
Department
Personal name
Funding Source
Organization
Kanagawa occupational therapist society
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Minato sekijuji hospital
Imusu yokohama kariba neurosurgery hospital
Saiseikai kanagawa ken hospital
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 | 09 | Month | 04 | 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
| 2016 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 21 | 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
| 2017 | Year | 09 | Month | 02 | Day |
Last modified on
| 2017 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033152
| 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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