UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011655 |
|---|---|
| Receipt number | 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 | 2022/06/09 17:55:43 |
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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
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
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
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
mstshnd46180@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine, Nagasaki University Hospital
Institute
Department
Personal name
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
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
| 2013 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 04 | Day |
Last modified on
| 2022 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013604
