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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041770
Receipt No. R000047676
Scientific Title Evaluation of mediVR-KAGURA guided Therapy: A Prospective Interventional Study
Date of disclosure of the study information 2020/09/13
Last modified on 2020/09/14

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Basic information
Public title Evaluation of mediVR-KAGURA guided Therapy: A Prospective Interventional Study
Acronym KAGURA challenge
Scientific Title Evaluation of mediVR-KAGURA guided Therapy: A Prospective Interventional Study
Scientific Title:Acronym KAGURA Study
Region
Japan

Condition
Condition Physical and cognitive dysfunctions such as ataxia, walking or balancing disabilities, higher brain dysfunction, attention deficit, and/or unilateral spatial neglect regardless of baseline disorders
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of mediVR-KAGURA guided therapy for the treatments of physical and cognitive dysfunctions
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Physical and cognitive indices such as Timed up and go test (TUG) or Trail Making Test (TMT), which will be selected based on each baseline disease
Key secondary outcomes Physical and cognitive indices excluding primary outcomes, which will be selected based on each baseline disease

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 mediVR-KAGURA guided therapy
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
6 years-old <=
Age-upper limit
110 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with physical and/or cognitive dysfunctions
2. Agreed to the participation of this study with written informed consent by themselves or guardians
Key exclusion criteria 1. Inappropriate candidates at attending physician's discretion
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Masahiko
Middle name
Last name Hara
Organization Cloud Clinic
Division name Department of Clinical Investigation
Zip code 6650066
Address Nigawadanchi 4-1, Takarazuka, Hyogo, Japan
TEL 0798317588
Email hara@cloudclinic.online

Public contact
Name of contact person
1st name Masahiko
Middle name
Last name Hara
Organization Cloud Clinic
Division name Department of Clinical Investigation
Zip code 6650066
Address Nigawadanchi 4-1, Takarazuka, Hyogo, Japan
TEL 0798317588
Homepage URL
Email hara@cloudclinic.online

Sponsor
Institute Cloud Clinic
Institute
Department

Funding Source
Organization NA
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 Japan Society of Clinical Research
Address Kita-ku Umeda 1-11-4-1000 Osaka Ekimae 4th Bldg 10F Osaka, 530-0001 Japan
Tel 06-6131-5495
Email hara@japanscr.org

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 09 Month 13 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
2020 Year 08 Month 01 Day
Date of IRB
2020 Year 08 Month 20 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2022 Year 08 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 09 Month 13 Day
Last modified on
2020 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047676

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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