UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050882 |
|---|---|
| Receipt number | R000057988 |
| Scientific Title | On the effect of combined neuromuscular electrical stimulation and eccentric contraction training on the intrinsic muscles of the foot in healthy adults. A single-blind randomized controlled trial. |
| Date of disclosure of the study information | 2023/04/20 |
| Last modified on | 2023/04/19 01:03:11 |
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Basic information
Public title
A single-blind, randomized, controlled trial of the raining effects of combined electrical stimulation and eccentric contraction on foot muscles in normal adults.
Acronym
A single-blind, randomized, controlled trial of the raining effects of combined electrical stimulation and eccentric contraction on foot muscles in normal adults.
Scientific Title
On the effect of combined neuromuscular electrical stimulation and eccentric contraction training on the intrinsic muscles of the foot in healthy adults. A single-blind randomized controlled trial.
Scientific Title:Acronym
On the effect of combined neuromuscular electrical stimulation and eccentric contraction training on the intrinsic muscles of the foot in healthy adults. A single-blind randomized controlled trial.
Region
| Japan |
Condition
Condition
Flat foot.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the immediate effects of a training method that combines electrical stimulation and eccentric contraction on strengthening the intrinsic foot muscles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle cross-sectional area
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Electrical Stimulation and eccentric contraction
Interventions/Control_2
Electrical stimulation
Interventions/Control_3
No intervention
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Normal Adults
Key exclusion criteria
Exercise restrictions by doctors
Cardiovascular disease
History of stroke or seizure
Infection
Lower limb injury
Surgical history less than a year ago
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kengo |
| Middle name | |
| Last name | Fukuda |
Organization
Department of Rehabilitation Innoshima Ishikai Hospital
Division name
Rehabilitation department
Zip code
7222211
Address
1962 Nakanosyou-cyo,Innoshima,Onomichi-shi,Hiroshima
TEL
0845-24-1210
511kengofukuda@gmail.com
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Fukuda |
Organization
Department of Rehabilitation Innoshima Ishikai Hospital
Division name
Rehabilitation department
Zip code
7222211
Address
1962 Nakanosyou-cyo,Innoshima,Onomichi-shi,Hiroshima
TEL
0845-24-1210
Homepage URL
511kengofukuda@gmail.com
Sponsor or person
Institute
Department of Rehabilitation Innoshima Ishikai Hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
Prefectural University of Hiroshima
Address
1-1 Gakuen-cho, Mihara-shi, Hiroshima
Tel
0848601225
511kengofukuda@gmail.com
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 | 20 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 25 | 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
| 2023 | Year | 04 | Month | 19 | Day |
Last modified on
| 2023 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057988
| 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 |
