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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034175
Receipt No. R000038846
Scientific Title Telemedicine using smart glasses, wearable computer glasses, in patients with Parkinson's disease.
Date of disclosure of the study information 2018/09/18
Last modified on 2018/09/18

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Basic information
Public title Telemedicine using smart glasses, wearable computer glasses, in patients with Parkinson's disease.
Acronym Telemedicine using smart glasses, wearable computer glasses, in patients with Parkinson's disease.
Scientific Title Telemedicine using smart glasses, wearable computer glasses, in patients with Parkinson's disease.
Scientific Title:Acronym Telemedicine using smart glasses, wearable computer glasses, in patients with Parkinson's disease.
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will test the usefulness of telemedicine (D to D to P) by smart glasses for patients with Parkinson's disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes MDS-UPDRS
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 Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 A local doctor (non-specialist) carries out regular medical examination for patients who live in a detached island diagnosed Parkinson's disease once a month for 6 months.This period is as the control period, and virtual specialized outpatient is held using smart glass followed by a neurologist in university hospital once a month for 6 months.
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 who satisfy all the following criteria are targeted.
1. The patient who desire a virtual expert clinic and can visit one year.
2. The patient who satisfy the criteria; by the Ministry of Health, Labor and Welfare Specific Disease Research Group, UK Parkinson 's Disease Society Brain Bank Criteria (1992), or diagnostic criteria of Movement Disorder Society (MDS).

3. Outpatient.
4. 20 years old or over.
5. Gender does not matter.
6. The patient who consent to join this research with full understanding.
Key exclusion criteria Patients applicable to even one of the following are excluded as subjects.
1. The patient who is in the outpatient specialized in neurology
2. The patients who do not wish to have a virtual nerve specialized clinic
3. The patients who were judged inappropriate as researchers
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teiichirou Miyazaki
Organization Nagasaki University Hospital
Division name Department of Neurology and Strokology
Zip code
Address 1-7-1, Sakamoto, Nagasaki City, Nagasaki, Japan
TEL 095-819-7200
Email teacomet@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Teiichirou Miyazaki
Organization Nagasaki University Hospital
Division name Department of Neurology and Strokology
Zip code
Address 1-7-1, Sakamoto, Nagasaki City, Nagasaki, Japan
TEL 095-819-7200
Homepage URL
Email teacomet@hotmail.com

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
Address
Tel
Email

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
2018 Year 09 Month 18 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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 18 Day
Last modified on
2018 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038846

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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