UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034942 |
|---|---|
| Receipt number | 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 | 2025/03/12 12:26:50 |
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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 | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3833
michiyukikawakami@hotmail.com
Public contact
Name of contact person
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3833
Homepage URL
michiyukikawakami@hotmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
Keio University
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3833
y.takahashi.jk@juntendo.ac.jp
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
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039629
