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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034320
Receipt No. R000039127
Scientific Title Association of the plantar pressure and Sarcopenia in people with Diabetes
Date of disclosure of the study information 2018/11/01
Last modified on 2018/09/29

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Basic information
Public title Association of the plantar pressure and Sarcopenia in people with Diabetes
Acronym Association of the plantar pressure and Sarcopenia in people with Diabetes
Scientific Title Association of the plantar pressure and Sarcopenia in people with Diabetes
Scientific Title:Acronym Association of the plantar pressure and Sarcopenia in people with Diabetes
Region
Japan

Condition
Condition (1) Diabetes
(2) Healthy subjects
Classification by specialty
Endocrinology and Metabolism Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aimed to identify Rehabilitation methods to prevent lower limb amputation. We evaluate association of peak plantar pressure and muscle strength, muscle mass, Sarcopenia in Diabetes and Healthy subjects .
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes peak plantar pressure during gait
Key secondary outcomes skeletal muscle mass
handgrip strength
gait speed
thickness and cross-sectional area of the foot
toe grip strength
patient education
fall history

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 No plantar ulcer
Key exclusion criteria The use of walking aids
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Yoshida
Organization Kawasaki Medical School Hospital
Division name Rehabilitation Center
Zip code
Address 577 Matsushima, Kurashiki city, Okayama, Japan
TEL 086-462-1111
Email pt.yoshdia@hp.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Yoshida
Organization Kawasaki Medical School Hospital
Division name Rehabilitation Center
Zip code
Address 577 Matsushima, Kurashiki city, Okayama, Japan
TEL 086-462-1111
Homepage URL
Email pt.yoshdia@hp.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
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
2018 Year 11 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
2018 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational

Management information
Registered date
2018 Year 09 Month 29 Day
Last modified on
2018 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039127

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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