UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044618 |
|---|---|
| Receipt number | R000050791 |
| Scientific Title | Verification of exercise menus that influence the psychosocial function of the visually impaired |
| Date of disclosure of the study information | 2021/06/23 |
| Last modified on | 2022/06/29 09:13:38 |
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Basic information
Public title
Verification of exercise menus that influence the psychosocial function of the visually impaired
Acronym
Verification of exercise menus that influence the psychosocial function of the visually impaired
Scientific Title
Verification of exercise menus that influence the psychosocial function of the visually impaired
Scientific Title:Acronym
Verification of exercise menus that influence the psychosocial function of the visually impaired
Region
| Japan |
Condition
Condition
Visually impaired
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify exercise menus that influence the psychosocial function of the visually impaired.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS-2, VFQ-25, SOC
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
2 weeks of exercise intervention > 2 weeks of upper limb sensory training intervention
Interventions/Control_2
2 weeks of upper limb sensory training intervention > 2 weeks of exercise intervention
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Either "Corrected visual acuity of the better eye is less than 0.5" or "Scotoma or defect in the visual field" is satisfied.
Key exclusion criteria
Mental disorders caused by mental illnesses such as intellectual disability, developmental disability and schizophrenia.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Nishida-Shimizu |
Organization
National Rehabilitation Center for Persons with Disabilities
Division name
Hospital, Department of Medical Treatment(2), (Research Institute)
Zip code
359-8555
Address
4-1, Namiki, Tokorozawa, Saitama
TEL
0429953100
shimizu-tomomi@rehab.go.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Nishida-Shimizu |
Organization
National Rehabilitation Center for Persons with Disabilities
Division name
Hospital, Department of Medical Treatment(2), (Research Institute)
Zip code
359-8555
Address
4-1, Namiki, Tokorozawa, Saitama
TEL
0429953100
Homepage URL
shimizu-tomomi@rehab.go.jp
Sponsor or person
Institute
National Rehabilitation Center for Persons with Disabilities (Research Institute)
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Rehabilitation Center for Persons with Disabilities
Address
4-1, Namiki, Tokorozawa, Saitama
Tel
0429953100
kikakurinnri@mhlw.go.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
| 2021 | Year | 06 | Month | 23 | 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
29
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
| 2021 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 05 | 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
| 2021 | Year | 06 | Month | 22 | Day |
Last modified on
| 2022 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050791
| 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 |
