UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030190
Receipt No. R000034419
Scientific Title Single center, open-label, randomized control trial to clarify preventive efficacy of electric stimulation for muscle atrophy after trauma.
Date of disclosure of the study information 2017/12/01
Last modified on 2018/12/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Single center, open-label, randomized control trial to clarify preventive efficacy of electric stimulation for muscle atrophy after trauma.
Acronym Single center, open-label, randomized control trial to clarif-y preventive efficacy of electric stimulation for muscle atrophy after trauma.
Scientific Title Single center, open-label, randomized control trial to clarify preventive efficacy of electric stimulation for muscle atrophy after trauma.
Scientific Title:Acronym Single center, open-label, randomized control trial to clarif-y preventive efficacy of electric stimulation for muscle atrophy after trauma.
Region
Japan

Condition
Condition pelvis fracture
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For patients who require bed rest for more than 1 week due to pelvic fractures, we investigate whether decrease of muscle volumes can be suppressed by performing muscle electrical stimulation in addition to national rehabilitation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We compare the cross-sectional area of the femur measured by the CT on baseline (A) with the same area measured by CT on the 14-day from baseline (B) and calculate the ratio (A/ B). And we measure the decrease rates.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The autotens pro belt electrode is put in the area of the abdomen, the distal part of both femurs and the ankle. It turns on electricity to the whole lower limbs. The output frequency is 20 Hz and energization for 5 seconds are carried out and the cycle of pause of 2 seconds is performed for 20 minutes. These stimulates are carried out once a day for 5 days a week. The current value is 2 to 15 mA.
The current value is set to the maximum value over three days if the patient does not feel uncomfortable to these stimulates.
Interventions/Control_2 routinely rehabilitation
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria over 20, less than 90 years old
Unstable type pelvic fracture, or pelvic fracture with weighting area. The patients with these pelvic fractures who required bed rest for more than 1 week.
The patients with these pelvic fracture who receive the pelvis to femur of the CT scan.
Key exclusion criteria The patients who are inserted a pacemaker.
The patients have the following past history; neuromuscular disorder (polio, myasthenia gravis, Guillain-Barre etc.), cerebral infarction (complete paralysis, contracture)
The patients who can not follow instructions due to loss of consciousness.
ADL is a wheelchair, bedridden, or the patients with femoral neck trochanter fracture
The patients have the bowel injuries or the pancreatic injuries of the Japanese association for the surgery trauma injury score over 2 scores.
The patients have the bowel injuries with Abbreviated Injury Scale over 2points. The patient who the attending doctor judged that fasting management is necessary
The patients with fractures or skin damage (excluding contusion) in the EMS site (thighs, knee joints, ankle joints)
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Kimura
Organization National Center for Global Health and Medicine
Division name Emergency Department
Zip code
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo
TEL 03-3202-7181
Email akimura@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makiko Yamamoto
Organization National Center for Global Health and Medicine
Division name Emergency Department
Zip code
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo
TEL 03-3202-7181
Homepage URL
Email makiyamamoto@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Emergency Department
Institute
Department

Funding Source
Organization Grants-in-Aid for Research from the National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 01 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 Open public recruiting
Date of protocol fixation
2017 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 30 Day
Last modified on
2018 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034419

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.