UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026081 |
|---|---|
| Receipt number | 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 13:23:17 |
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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
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
h.kataoka59@gmail.com
Sponsor or person
Institute
KKR Takamatsu Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029970
