UMIN-CTR Clinical Trial

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

pelvis fracture

Classification by specialty

Emergency medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

National Center for Global Health and Medicine
Emergency Department

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

11

Month

30

Day

Last modified on

2018

Year

12

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034419