UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014847 |
|---|---|
| Receipt number | R000017232 |
| Scientific Title | The stimulation somatosensory affects the ankle instability and sprain incidence |
| Date of disclosure of the study information | 2014/08/20 |
| Last modified on | 2016/08/29 12:39:37 |
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Basic information
Public title
The stimulation somatosensory affects the ankle instability and sprain incidence
Acronym
The stimulation somatosensory affects the ankle instability and sprain incidence
Scientific Title
The stimulation somatosensory affects the ankle instability and sprain incidence
Scientific Title:Acronym
The stimulation somatosensory affects the ankle instability and sprain incidence
Region
| Japan |
Condition
Condition
ankle instability
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to reveal the effects of balance training and TENS. The participants are athletes who suffer with ankle instability. They were measured their muscular strength, muscle reaction time, balance test, EMG test, a jump test.
Furthermore, researchers examine the influence of balance training and TENS to the ankle instability and performance. In addition the effects for ankle sprain incidence rate of each intervention were also investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
The incidence of ankle instability
Key secondary outcomes
(1) We have 4 times measurements at a start and 6th week, 12th week, 24th week.
The measurements contain balance test, muscle reaction time, muscle activity on jump performance, muscle strength.
(2) Side effects of the TENS (skin rash, burning sensation).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention: Balance training (Basic treatment) and TENS (Under the guidance of the head research representatives gives, the participants are attached with the electrode pads onto the muscle of the peroneus longus and the peroneus brevis by themselves, and are performed with 5 Hz electric stimulations for 15 minutes 3times a week for 24 weeks period.)
Interventions/Control_2
Control: Balance training (Basic treatment)
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
Female
Key inclusion criteria
Karlsson Score<80, or CAIT<27
Key exclusion criteria
A person visiting a hospital for treatment because of a primary illness and the person who takes medication.(diabetes, heart disease, kidney disease, liver disease, hyponatremia, refractory hypertension)
The person who has the medical history of lower limbs surgery.
The person who has difficulty to exercise due to an ankle instability which is high excessively.
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YOSHIDA NARUTO |
Organization
Teikyo Heisei University
Division name
Faculty of Health Care
Zip code
Address
Toshima-ku, Tokyo 170-8445, Japan
TEL
81358433111
n.yoshida@thu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YOSHIDA NARUTO |
Organization
Teikyo Heisei University
Division name
Faculty of Health Care
Zip code
Address
Toshima-ku, Tokyo 170-8445, Japan
TEL
81358433111
Homepage URL
n.yoshida@thu.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
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
Address
Tel
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
筑波大学（茨城県）、茨城大学（茨城県）、福岡大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | 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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 12 | Day |
Last modified on
| 2016 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017232
| 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 |
