UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055959 |
|---|---|
| Receipt number | R000063950 |
| Scientific Title | Research on the effects of home use of a visually induced kinesthetic illusion system on brain and body functions |
| Date of disclosure of the study information | 2024/10/27 |
| Last modified on | 2025/04/23 10:48:07 |
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Basic information
Public title
Research on the effects of home use of a visually induced kinesthetic illusion system on brain and body functions
Acronym
Research on the effects of home use of a visually induced kinesthetic illusion system
Scientific Title
Research on the effects of home use of a visually induced kinesthetic illusion system on brain and body functions
Scientific Title:Acronym
Research on the effects of home use of a visually induced kinesthetic illusion system
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of home use of the visually induced kinesthetic illusion system on brain and physical functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fractional anisotropy value
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using the visually induced kinesthetic illusion system at home
Interventions/Control_2
Stretching at home
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Written informed consent.
Key exclusion criteria
In accordance with the safety standards of magnetic resonance imaging facilities, the following patients will be excluded from this study:
1. those who have a cardiac pacemaker or artificial heart valve
2. those who have severe cardiac disease
3. those who are dependent on internal or external life support devices
4. those who have metal arterial clips in the cranium
5. those who have surgical clips or ferromagnetic materials in the body for hemostasis
6. those who have cochlear implants
7. persons who may have metal fragments in their body
8. persons with tattoos or art makeup
9. persons who may be claustrophobic
Persons who may suffer from bronchial asthma or allergic chronic diseases
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University
Division name
Rehabilitation Medicine, Graduate School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3833
michiyukikawakami@hotmail.com
Public contact
Name of contact person
| 1st name | Kenya |
| Middle name | |
| Last name | Tanamachi |
Organization
Keio University
Division name
Rehabilitation Medicine, Graduate School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3833
Homepage URL
k-tanamachi@tmu.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Other
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
Keio University
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3833
med-rinri-jimu@adst.keio.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
| 2024 | Year | 10 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2024 | Year | 10 | Month | 27 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063950
