UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006735 |
|---|---|
| Receipt number | R000007956 |
| Scientific Title | Effect of proprioceptive inputs induced by tibial nerve electrical stimulation on spinal reflex and mechanical property in lower extremities in humans |
| Date of disclosure of the study information | 2011/11/17 |
| Last modified on | 2015/05/16 10:51:10 |
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Basic information
Public title
Effect of proprioceptive inputs induced by tibial nerve electrical stimulation on spinal reflex and mechanical property in lower extremities in humans
Acronym
Effect of tibial nerve electrical stimulation on spinal reflex and mechanical property in lower extremities
Scientific Title
Effect of proprioceptive inputs induced by tibial nerve electrical stimulation on spinal reflex and mechanical property in lower extremities in humans
Scientific Title:Acronym
Effect of tibial nerve electrical stimulation on spinal reflex and mechanical property in lower extremities
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine soleus H-reflex and motor property after calf-raise training with and without neuromuscular electrical stimulation (NMES) training in healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
evoked electromyography
Key secondary outcomes
motor function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Calf-raise training (15 repetitions, 4 sets, 10 days)
Interventions/Control_2
Calf-raise training (15 repetitions, 4 sets, 10 days) with transcutaneous neuromuscular electrical stimulation applied to tibial nerve (75 Hz rectangular pulse, 400 micro sec duration, maximal intensity below sensory threshold)
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
healthy adults, who give written informed consent after detailed explanation of the study
Key exclusion criteria
neurological and/or orthopedic history, medical diagnosis with limitation of exercise exertion in past one year
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken'ichi Egawa |
Organization
Meiji Yasuda Life Foundation of Health and Welfare
Division name
Service Department
Zip code
Address
1-8-3 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-3349-2750
egaken-ind@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken'ichi Egawa |
Organization
Meiji Yasuda Life Foundation of Health and Welfare
Division name
Service Department
Zip code
Address
1-8-3 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-3349-2750
Homepage URL
egaken-ind@umin.ac.jp
Sponsor or person
Institute
Meiji Yasuda Life Foundation of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
School of Technology for Social Medicine
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
社会医学技術学院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 22 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 16 | Day |
Last modified on
| 2015 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007956
