UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the physical therapy effect with toe pinch force in patients with type 2 diabetes mellitus
Title of the study (Brief title)	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	Hiroaki Kataoka
Organization	KKR Takamatsu Hospital
Division name	Rehabilitation center
Address	4-18, Tenjinmae, Takamatsu, Kagawa 760-0018, Japan
TEL	087-861-3261
Email	h.kataoka59@gmail.com

Public contact
Name of contact person	Hiroaki Kataoka
Organization	KKR Takamatsu Hospital
Division name	Rehabilitation center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://link.springer.com/article/10.1007/s13340-017-0318-y
Results
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