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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026081
Receipt No. R000029970
Scientific Title A study of the physical therapy effect with toe pinch force in patients with type 2 diabetes mellitus
Date of disclosure of the study information 2017/02/11
Last modified on 2017/11/27

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Basic information
Public title A study of the physical therapy effect with toe pinch force in patients with type 2 diabetes mellitus
Acronym A study of the physical therapy effect with toe pinch force in patients with type 2 diabetes mellitus
Scientific Title A study of the physical therapy effect with toe pinch force in patients with type 2 diabetes mellitus
Scientific Title:Acronym A study of the physical therapy effect with toe pinch force in patients with type 2 diabetes mellitus
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The first objective is to compare the toe pinch force with and without type 2 diabetes mellitus. The second objective is to examine the effect of toe resistance training.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in toe pinch force and motor function before and after hospitalization.
Key secondary outcomes Changes in toe pinch force and motor function after discharge.

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Daily exercise education with toe resistance training during hospitalization.
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
30 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Inpatients with type 2 diabetes give written informed consent to participate in the study.
Key exclusion criteria 1. Dysesthesia with one side lower limbs and upper limbs.
2. Patients having acute metabolic disorders.
3. Patients with acute or chronic bone and joint disease, and cerebral vascular disease.
4. Patients having foot/toe deformity, or muscle atrophy and edema of the foot.
5. Patients whose daily activities are highly restricted.
6. Patients hospitalized for surgery.
7. Patients who seem inappropriate for this study by investigations.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Kataoka
Organization KKR Takamatsu Hospital
Division name Rehabilitation center
Zip code
Address 4-18, Tenjinmae, Takamatsu, Kagawa 760-0018, Japan
TEL 087-861-3261
Email h.kataoka59@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Kataoka
Organization KKR Takamatsu Hospital
Division name Rehabilitation center
Zip code
Address 4-18, Tenjinmae, Takamatsu, Kagawa 760-0018, Japan
TEL 087-861-3261
Homepage URL
Email h.kataoka59@gmail.com

Sponsor
Institute KKR Takamatsu Hospital
Institute
Department

Funding Source
Organization 114 bank, Kagawa Prefecture, Japan
Organization
Division
Category of Funding Organization Non profit foundation
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 KKR高松病院(香川県)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007/s13340-017-0318-y
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 Completed
Date of protocol fixation
2014 Year 09 Month 19 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
2017 Year 03 Month 10 Day
Date of closure to data entry
2017 Year 03 Month 24 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 04 Month 28 Day

Other
Other related information

Management information
Registered date
2017 Year 02 Month 10 Day
Last modified on
2017 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029970

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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