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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034942
Receipt No. R000039629
Scientific Title The electrophysiological study of spinal circuits controlling movement of lower limb
Date of disclosure of the study information 2018/11/19
Last modified on 2019/03/29

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Basic information
Public title The electrophysiological study of spinal circuits controlling movement of lower limb
Acronym The study of spinal circuits involved in lower limb movement
Scientific Title The electrophysiological study of spinal circuits controlling movement of lower limb
Scientific Title:Acronym The study of spinal circuits involved in lower limb movement
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the state of heteronymous facilitation (HF) and reciprocal inhibition (RI) in healthy subjects
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Electrophysiological assessments
Heteronymous facilitation (HF)
Reciprocal inhibition (RI)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria No medical history of motor musculoskeletal illness of lower extremity and neurological disorder
Key exclusion criteria 1.Serious cardiac disease: unstable angina, myocardial infarction shortly after symptom onset, decompensated congestive heart failure, acute cor pulmonale, uncontrolled arrhythmia, serious aortic stenosis, active myocarditis, endocarditis, etc.
2.Uncontrolled hypertension
3.Acute systemic disease or fever
4.Complication of recent pulmonary embolism, acute cor pulmonale or serious pulmonary hypertension
5.Complication of serious liver or renal dysfunction
6.Complication of serious orthopedic disease which bars exercise capability
7.Complication of serious cognitive dysfunction or psychiatric disorder
8.Other metabolic abnormality (acute thyroiditis, etc.)
9.Implanted electronic pacing or defibrillation devices
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiyuki Kawakami
Organization Keio University School of Medicine
Division name Department of Rehabilitation
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3833
Email michiyukikawakami@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Michiyuki Kawakami
Organization Keio University School of Medicine
Division name Department of Rehabilitation
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3833
Homepage URL
Email michiyukikawakami@hotmail.com

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Government offices of other countries
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 YES
Study ID_1 2018-0194
Org. issuing International ID_1 Keio University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 19 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
2018 Year 11 Month 19 Day
Date of IRB
2018 Year 11 Month 19 Day
Anticipated trial start date
2018 Year 11 Month 20 Day
Last follow-up date
2019 Year 03 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Electrophysiological evaluation of RI and HF is carried out in one evaluation.

Management information
Registered date
2018 Year 11 Month 19 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039629

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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