UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024870 |
|---|---|
| Receipt number | R000028624 |
| Scientific Title | Effect of the belt-style skeletal muscle stimulation therapy on seriously ill ischemic limb patient |
| Date of disclosure of the study information | 2016/11/17 |
| Last modified on | 2021/11/30 08:24:49 |
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Basic information
Public title
Effect of the belt-style skeletal muscle stimulation therapy on seriously ill ischemic limb patient
Acronym
Effect of the belt-style skeletal muscle stimulation therapy on seriously ill ischemic limb patient
Scientific Title
Effect of the belt-style skeletal muscle stimulation therapy on seriously ill ischemic limb patient
Scientific Title:Acronym
Effect of the belt-style skeletal muscle stimulation therapy on seriously ill ischemic limb patient
Region
| Japan |
Condition
Condition
critical limb ischaemia patient
Classification by specialty
| Cardiology | Cardiovascular surgery | Plastic surgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For patients with severe ischemic limbs, in addition to usual rehabilitation, belt type skeletal muscle stimulation therapy is used in combination to examine the effect on daily living ability, mental function and peripheral blood flow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Skin reflux pressure
*Every 2 weeks
Key secondary outcomes
Knee extension muscle force
Daily living behavior
Health related QOL
Depressed state
Cognitive function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform normal rehabilitation
Interventions/Control_2
Perform normal rehabilitation and belt type skeletal muscle stimulation therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Severe ischemic cases during hospitalization
Key exclusion criteria
1.Person who ranked independence degree (bedridden degree) in daily life rank C
2.Those who can not walk even if using welfare tools etc.
3.Severe cognitive impairment (MMSE: 21 points or less)
4.Those who can not obtain consent
5.Person who judged inappropriate by researcher or cooperative researcher
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Tamatani/Kaori Sochi |
Organization
Kawashima Kaijima Hospital for Social Medical Corporation
Division name
Rehabilitation room/nursing department
Zip code
Address
1-1-39 Kitasako,Tokushima,770-8548,Japan
TEL
088-631-0110
reha.tamatani@khg.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Tamatani |
Organization
Kawashima Kaijima Hospital for Social Medical Corporation
Division name
Rehabilitation room
Zip code
Address
1-1-39 Kitasako,Tokushima,770-8548,Japan
TEL
088-631-0110
Homepage URL
reha.tamatani@khg.or.jp
Sponsor or person
Institute
Kawashima Kaijima Hospital for Social Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 17 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 17 | Day |
Last modified on
| 2021 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028624
