UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033239 |
|---|---|
| Receipt number | R000037898 |
| Scientific Title | To comparison between the effects of hip muscle strengthening and balance training for chronic ankle instability |
| Date of disclosure of the study information | 2018/07/03 |
| Last modified on | 2020/05/17 14:37:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
To comparison between the effects of hip muscle strengthening and balance training for chronic ankle instability
Acronym
To comparison between the effects of hip muscle strengthening and balance training for chronic ankle instability
Scientific Title
To comparison between the effects of hip muscle strengthening and balance training for chronic ankle instability
Scientific Title:Acronym
To comparison between the effects of hip muscle strengthening and balance training for chronic ankle instability
Region
| Japan |
Condition
Condition
chronic ankle instability
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To comparison between the effects of hip muscle strengthening and balance training
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Star Excursion Balance Test
Balance Error Scoring System
Strength of hip abductor and external rotator
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
hip muscle strengthening
Interventions/Control_2
balance training
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a history of at least 1 significant ankle sprain
at least 2 episodes of giving way in the 6 months prior study enrollment or at least two ankle sprains to the same ankle
Cumberland Ankle Instability Tool is less than or equal to 24 points
Key exclusion criteria
a history of first ankle sprain in the previous one year
a history of at least 1 ankle sprain in the previous 3 month
a history of a fracture or previous surgeries in either limb of the lower extremity
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Harukazu Tohyama |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
Address
Kita 12 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-3393
tohyama@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromu Murata |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
Address
Kita 12 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
080-6075-5726
Homepage URL
babystep6781@gmail.com
Sponsor or person
Institute
Hokkaido University Faculty of Health Sciences
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 03 | 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
| 2018 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 02 | Day |
Last modified on
| 2020 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037898
