UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045407 |
|---|---|
| Receipt number | R000051843 |
| Scientific Title | Effect of foam rolling on during ankle fixation prevents the reduction of ankle dorsiflexion angle-Randomized Controlled Trials- |
| Date of disclosure of the study information | 2021/09/12 |
| Last modified on | 2021/09/17 19:37:08 |
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Basic information
Public title
Effect of foam rolling on during ankle fixation prevents the reduction of ankle dorsiflexion angle-Randomized Controlled Trials-
Acronym
Effect of foam rolling on during ankle fixation prevents the reduction of ankle dorsiflexion angle
Scientific Title
Effect of foam rolling on during ankle fixation prevents the reduction of ankle dorsiflexion angle-Randomized Controlled Trials-
Scientific Title:Acronym
Effect of foam rolling on during ankle fixation prevents the reduction of ankle dorsiflexion angle
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
About the preventive effect on the range of motion of the foam roller after fixing the ankle joint
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before ankle fixation and after ankle fixation range of motion
Key secondary outcomes
(1)Ease of movement of joints of before ankle fixation
(2)After measuring the range of motion of the ankle dorsiflexion, the subject
Questionnaire on the fixed side
(3)Questionnaire on the fixed side of the target person after FR
(4)Questionnaire on the strength of left and right FR to the target person
(5)Changes in the ease of movement of the ankle joint after removal of the supporter
(6)Lower leg circumference
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Ankle fixation+Foam Rolling
Interventions/Control_2
Ankle fixation
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
No history of both ankle joints
Key exclusion criteria
(1)Have a history of either ankle joint
(2)Intervention has not been completed for more than 3 days
(3)If the supporter cannot be fixed for 5 days
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kouji |
| Middle name | |
| Last name | Koyama |
Organization
Tokyo Ariake University of Medical and Health Science
Division name
Faculty of Health Science
Zip code
135-0063
Address
2-9-1 Ariake, Koto-ku, Tokyo 135-0063 Japan
TEL
03-6703-7000
5120002@tau.ac.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Kobune |
Organization
Tokyo Ariake University of Medical and Health Science
Division name
Graduate School of Health Science
Zip code
135-0063
Address
2-9-1 Ariake, Koto-ku, Tokyo 135-0063 Japan
TEL
03-6703-7000
Homepage URL
5120002@tau.ac.jp
Sponsor or person
Institute
Tokyo Ariake University of Medical and Health Science
Institute
Department
Personal name
Funding Source
Organization
Tokyo Ariake University of Medical and Health Science
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
Tokyo Ariake University of Medical and Health Science
Address
2-9-1 Ariake, Koto-ku, Tokyo 135-0063 Japan
Tel
03-6703-7000
akiyama@tau.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
| 2021 | Year | 09 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 01 | 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
| 2021 | Year | 09 | Month | 07 | Day |
Last modified on
| 2021 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051843
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
