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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024207
Receipt No. R000027866
Scientific Title Effects of navigation system for rehabilitation using digital mirror device in physical activities in patients with dialysis
Date of disclosure of the study information 2016/10/01
Last modified on 2016/09/28

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Basic information
Public title Effects of navigation system for rehabilitation using digital mirror device in physical activities in patients with dialysis
Acronym Effects of navigation system for rehabilitation using digital mirror device in physical activities in patients with dialysis
Scientific Title Effects of navigation system for rehabilitation using digital mirror device in physical activities in patients with dialysis
Scientific Title:Acronym Effects of navigation system for rehabilitation using digital mirror device in physical activities in patients with dialysis
Region
Japan

Condition
Condition hemodialysis patients
Classification by specialty
Nephrology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 improvement of the physical activity and abilities and the trunk imbalance, the activities of dairy living
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes the activities of daily living




Key secondary outcomes standing and sitting postures and trunk balance, mortality, the physical activity, acute myocardial infarction, PTCA and PTA, CHF require hospital care, cerebrovascular event require hospital care, pneumonia, malignancy, bone fracture and event of fall

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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Rehabilitation for 15 minutes using digital mirror device
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
85 years-old >=
Gender Male and Female
Key inclusion criteria patients receiving hemodialysis or peritoneal dialysis
Key exclusion criteria 1.patients who has difficulty in going to hospital
2.patients who judged that a doctor was inappropriate
3.patients who receives exercise function rehabilitation now
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hamada Chieko
Organization Juntendo University Hospital
Division name Nephrology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL 03-58020-1065
Email chieko@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nozaki Nao
Organization Juntendo University Hospital
Division name Nephrology
Zip code
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL 03-3813-3111
Homepage URL
Email nozaki-n@juntendo.ac.jp

Sponsor
Institute Ministry of Education, Culture, Sports, Science and Technology
Institute
Department

Funding Source
Organization Self funding
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
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
2016 Year 10 Month 01 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
2016 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 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
2016 Year 09 Month 28 Day
Last modified on
2016 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027866

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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