UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050915 |
|---|---|
| Receipt number | R000054347 |
| Scientific Title | A new rehabilitation method using virtual reality system |
| Date of disclosure of the study information | 2023/04/25 |
| Last modified on | 2024/04/24 10:15:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A new rehabilitation method using virtual reality system
Acronym
Rehabilitation and virtual reality
Scientific Title
A new rehabilitation method using virtual reality system
Scientific Title:Acronym
Rehabilitation and virtual reality
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of virtual reality system for chronic stroke patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Assessment of motor functions (Fugl-Meyer Assessment,Modified Ashworth Scale, range of motion, Box & Block test) > Training with virtual reality system (once per week, for ca. 6 months) > Assessment of motor functions
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with cerebrovascular disorders and neurological diseases. Those who are in the chronic phase and have stabilized symptoms. Individuals who score 25 or higher on the Montreal Cognitive Assessment (MoCA) and do not show signs of cognitive impairment."
Key exclusion criteria
Minors, individuals with suspected cognitive impairment even if they are of legal age, and those who lack sufficient decision-making capacity shall be excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | Ohki |
Organization
Kyorin University
Division name
School of Medicine
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
ohkiy@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukari |
| Middle name | |
| Last name | Ohki |
Organization
Kyorin University
Division name
Shool of Medicine
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
Homepage URL
ohkiy@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Kyorin University
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
Faculty of Medicine Research Ethics Committee, Kyorin University
Address
6-20-2 Shinkawa, Mitaka, Tokyo
Tel
0422-47-5511
rec@ks.kyorin-u.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
| 2023 | Year | 04 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 04 | Month | 24 | Day |
Last modified on
| 2024 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054347
