UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049748 |
|---|---|
| Receipt number | R000056645 |
| Scientific Title | Kinesiphysiological analysis of changes in subjectively intensities in belt electrode-skeletal muscle electrical stimulation |
| Date of disclosure of the study information | 2023/04/15 |
| Last modified on | 2023/12/13 09:13:45 |
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Basic information
Public title
Kinesiphysiological analysis of changes in subjectively intensities in belt electrode-skeletal muscle electrical stimulation
Acronym
Kinesiphysiological analysis of changes in subjectively intensities in belt electrode-skeletal muscle electrical stimulation
Scientific Title
Kinesiphysiological analysis of changes in subjectively intensities in belt electrode-skeletal muscle electrical stimulation
Scientific Title:Acronym
Kinesiphysiological analysis of changes in subjectively intensities in belt electrode-skeletal muscle electrical stimulation
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate exercise physiology changes associated with changing of different subjective intensity in belt-type skeletal muscle electrical stimulation the belt electrode skeletal muscle electrical stimulation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Metabolic equivalent
Key secondary outcomes
oxygen uptake, blood pressure, heart rate, respiratory rate, pain, and general fatigue
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Belt electrode-electrical stimulation is performed at different subjective intensities.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers affiliated with Kyoto Prefectural University of Medicine who consented to participation in this study.
Key exclusion criteria
1. pregnancy or possible pregnancy
2. cardiac pacemaker
3. uncontrolled hypertension
4. exercise limitations associated with action disorder of heart
5. hematogenous disorder of lower extremity
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mikami |
| Middle name | |
| Last name | Yasuo |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5324
reha@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Hishikawa |
| Middle name | |
| Last name | Norikazu |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5324
Homepage URL
hisikawa@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Pref ectural University of Medicine
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medical Science, Kyoto Pref ectural University of Medicine
Address
Department of Rehabilitation Medicine
Tel
075-251-5324
reha@koto.kpu-m.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056645
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
