UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048107 |
|---|---|
| Receipt number | R000054757 |
| Scientific Title | Study of a tactile tape bisection test -Comparison of healthy and visually impaired- |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2023/06/20 11:45:38 |
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Basic information
Public title
Study of a tactile tape bisection test
-Comparison of healthy and visually impaired-
Acronym
Tactile tape bisection test
Scientific Title
Study of a tactile tape bisection test
-Comparison of healthy and visually impaired-
Scientific Title:Acronym
Tactile tape bisection test
Region
| Japan |
Condition
Condition
healthy/visually impaired
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the average function of tactile spatial cognition in healthy and visually impaired people by a tape bisection test.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of deviation from the center of the tape bisection test(mm)
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Subject pinches the center of the tape (50 cm) with eyes closed
Perform twice and adopt the one with the larger deviation amount
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy
2)Visually impaired
The sum of the visual acuity of both eyes is 0.2 or less (equivalent to grade 5 or higher for the physically disabled)
Key exclusion criteria
1)Those with obvious cognitive dysfunction
2)Those with obvious cognitive dysfunction
Those with a visual impairment of less than 1 year
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shunosuke |
| Middle name | |
| Last name | Gomado |
Organization
Saiseikai Toyama Hospital
Division name
Department of Rehabilitation
Zip code
931-8533
Address
33-1 Kusunoki, Toyama City, Toyama Prefecture
TEL
076-437-1111
reha-ot@saiseikai-toyama.jp
Public contact
Name of contact person
| 1st name | Shunosuke |
| Middle name | |
| Last name | Gomado |
Organization
Saiseikai Toyama Hospital
Division name
Department of Rehabilitation
Zip code
931-8533
Address
33-1 Kusunoki, Toyama City, Toyama Prefecture
TEL
076-437-1111
Homepage URL
reha-ot@saiseikai-toyama.jp
Sponsor or person
Institute
Saiseikai Toyama Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Toyama Hospital
Address
33-1 Kusunoki, Toyama City, Toyama Prefecture
Tel
076-437-1111
hospital@saiseikai-toyama.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 | 07 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 20 | Day |
Last modified on
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054757
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
