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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040957
Receipt No. R000046771
Scientific Title Exploratory study in the development of new rehabilitation system using immersive virtual reality.
Date of disclosure of the study information 2020/06/30
Last modified on 2020/06/30

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Basic information
Public title Exploratory study in the development of new rehabilitation system using immersive virtual reality.
Acronym Exploratory rehabilitation study using immersive VR.
Scientific Title Exploratory study in the development of new rehabilitation system using immersive virtual reality.
Scientific Title:Acronym Exploratory rehabilitation study using immersive VR.
Region
Japan

Condition
Condition disuse syndrome,stroke
Classification by specialty
Medicine in general Neurology Surgery in general
Orthopedics Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To exmaine the effectiveness of rehabilitation with immersive VR.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of physical function and psychological assessment at baseline, 1 week after, and 2 weeks after the intervention.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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
Other
Interventions/Control_1 rehabilitation using immersive VR (case)
Interventions/Control_2 rehabilitation using immersive VR (control)
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
19 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients with the weakness of upper and lower limb(s) due to disuse syndrome.
Key exclusion criteria Patients who cannot engage in physical exercises due to other diseases or patients who cannot follow the exercise instruction due to cognitive impairments.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yasuo
Middle name
Last name Nakahara
Organization The University of Teikyo Hospital
Division name Department of Rehabilitation Science
Zip code 173-8606
Address 2-11-1 Kaga, Itabashi-Ku, Tokyo
TEL 03-3964-1211
Email VRreha@gmail.com

Public contact
Name of contact person
1st name Yasuo
Middle name
Last name Nakahara
Organization The University of Teikyo Hospital
Division name Department of Rehabilitation Science
Zip code 173-8606
Address 2-11-1 Kaga, Itabashi-Ku, Tokyo
TEL 03-3964-1211
Homepage URL
Email VRreha@gmail.com

Sponsor
Institute The University of Teikyo Hospital
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research(C)
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 Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address 2-11-1 Kaga, Itabashi-Ku, Tokyo
Tel 03-3964-7256
Email turb-office@teikyo-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
2020 Year 06 Month 30 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
2020 Year 06 Month 18 Day
Date of IRB
2020 Year 06 Month 18 Day
Anticipated trial start date
2020 Year 06 Month 30 Day
Last follow-up date
2025 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
2020 Year 06 Month 30 Day
Last modified on
2020 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046771

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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