UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056416 |
|---|---|
| Receipt number | R000064460 |
| Scientific Title | the effects of core muscle training using EMS |
| Date of disclosure of the study information | 2024/12/16 |
| Last modified on | 2026/01/16 14:08:17 |
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Basic information
Public title
the effects of core muscle training using EMS
Acronym
the effects of core muscle training using EMS
Scientific Title
the effects of core muscle training using EMS
Scientific Title:Acronym
the effects of core muscle training using EMS
Region
| Japan |
Condition
Condition
Healthy subjects, low back pain
Classification by specialty
| Rehabilitation medicine | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effects of trunk muscle training using EMS on muscle strength, flexibility, and balance ability
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle strength, flexibility, and balance ability before and after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
EMS Training
Interventions/Control_2
placebo
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
| 16 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subjects, low back pain
Key exclusion criteria
participants who have a tumor, obvious lumbar herniation, lumbar spinal canal stenosis, infections, musculoskeletal disorder, sciatic nerve compression and pain, sensory impairment, decreased muscle strength and reflex.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Wachi |
Organization
Bukkyo University
Division name
Department of Physical Therapy
Zip code
5270145
Address
7, Higashi-Togano-cho, Nishinokyo, Nakagyo-ku, Kyoto
TEL
0754912141
m-wachi@bukkyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Wachi |
Organization
Bukkyo Univertity
Division name
Department of Physical Therapy
Zip code
5270145
Address
7, Higashi-Togano-cho, Nishinokyo, Nakagyo-ku, Kyoto
TEL
08031379862
Homepage URL
m-wachi@bukkyo-u.ac.jp
Sponsor or person
Institute
Furu clinic
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa Orthopaedic & Sports Medicine Clinic
Address
881 Ono, Ritto, Shiga
Tel
0775530007
k.riha-workshop@kanazawaseikei.or.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
| 2024 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
36
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
| 2024 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 10 | Day |
Last modified on
| 2026 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064460
