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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033239
Receipt No. 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

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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
Email 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
Email babystep6781@gmail.com

Sponsor
Institute Hokkaido University Faculty of Health Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037898

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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