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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043625
Receipt No. R000049736
Scientific Title Correlation between ADL quantification using PLLA film and Barthel Index Score in elderly people.
Date of disclosure of the study information 2021/05/01
Last modified on 2021/03/16

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Basic information
Public title ADL quantification using ankle device and Barthel Index Score in elderly people.
Acronym ADL Study
Scientific Title Correlation between ADL quantification using PLLA film and Barthel Index Score in elderly people.
Scientific Title:Acronym PLLA-BI Study
Region
Japan

Condition
Condition elderly
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Quantification of activities of daily living by device
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the integral Piezoelectric Poly L-lactic Acid Film amplitude
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Subjects wear an ankle band with a built-in Piezoelectric Poly L-lactic Acid Film
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
65 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Elderly who go to a long-term care facility or enter
Key exclusion criteria Those who the researcher deems inappropriate
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Satoru
Middle name
Last name Iwase
Organization Saitama Medical University Hospital
Division name Department of Palliative Medicine
Zip code 350-0495
Address 38 Morohongou, Moroyama cho Iruma-gun, Saitama, Japan
TEL 049-726-1705
Email siwase@saitama-med.ac.jp

Public contact
Name of contact person
1st name Satoru
Middle name
Last name Iwase
Organization Saitama Medical University Hospital
Division name Department of Palliative Medicine
Zip code 350-0495
Address 38 Morohongou, Moroyama cho Iruma-gun, Saitama, Japan
TEL 049-726-1705
Homepage URL
Email siwase@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University Hospital
Institute
Department

Funding Source
Organization Murata Manufacturing Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Saitama Medical University
Address 38 Moro Hongo, Moroyama-cho, Iruma-gun, Saitama
Tel 049-276-2143
Email rinri@saitama-med.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
2021 Year 05 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
2021 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 13 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
2021 Year 03 Month 16 Day
Last modified on
2021 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049736

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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