UMIN-CTR Clinical Trial

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
Email	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
Email	reha.tamatani@khg.or.jp

Sponsor
Institute	Kawashima Kaijima Hospital for Social Medical Corporation
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028624