UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041770
Receipt number 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 2023/03/17 10:58:45

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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), Simple Test for Evaluating Hand Function (STEF) 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 or person

Institute

Cloud Clinic

Institute

Department

Personal name



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

2024 Year 12 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

2023 Year 03 Month 17 Day



Link to view the page

Value
https://center6.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