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Recruitment status Completed
Unique ID issued by UMIN UMIN000011655
Receipt No. R000013604
Scientific Title Effects of neuromuscular electrical stimulation of quadriceps force in patients after Living-donor liver transplantation
Date of disclosure of the study information 2013/09/04
Last modified on 2018/02/11

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Basic information
Public title Effects of neuromuscular electrical stimulation of quadriceps force in patients after Living-donor liver transplantation
Acronym Effects of neuromuscular electrical stimulation in patients after Living-donor liver transplantation
Scientific Title Effects of neuromuscular electrical stimulation of quadriceps force in patients after Living-donor liver transplantation
Scientific Title:Acronym Effects of neuromuscular electrical stimulation in patients after Living-donor liver transplantation
Region
Japan

Condition
Condition Patients after Living-donor liver transplantation
Classification by specialty
Hepato-biliary-pancreatic surgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effects of neuromuscular electrical stimulation of quadriceps force
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quadriceps force
Key secondary outcomes Activity of daily living
Post operative day

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Other
Interventions/Control_1 Intervention group:
We used electrical muscle stimulation.
Stimulation region:Quadriceps muscle
Intensity:Symmetrical biphasic square pulsed current at 45 Hz
Pulse:400 ms
Duty cycle:12 sec on and 6 sec off
Intensity:40-80 mA
Time:45 min 1session 5time per week

Control group:
Stimulation region:tibialis anterior muscle
Except for stimulation region, other intervention is same in both groups.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The adult patient that is possible to evaluated in patients of preoperative living doner liver transplantation.
Informed consent was obtained from all
patients prior to participation in the study.
Key exclusion criteria Musculoskeletal impairment
Cerebral vascular disorder
Severe visually and hearing impairment
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Hanada
Organization Nagasaki University Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7258
Email mstshnd46180@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masatoshi Hanada
Organization Nagasaki University Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7258
Homepage URL
Email mstshnd46180@nagasaki-u.ac.jp

Sponsor
Institute Department of Rehabilitation Medicine, Nagasaki University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 長崎大学病院(長崎県)

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 04 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
2013 Year 09 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 04 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
2013 Year 09 Month 04 Day
Last modified on
2018 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013604


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