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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040229
Receipt No. R000045892
Scientific Title The effects of hip-focused exercise intervention in individuals with chronic ankle instability: a randomized controlled trial.
Date of disclosure of the study information 2020/04/23
Last modified on 2020/10/22

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Basic information
Public title The effects of hip-focused exercise intervention in individuals with chronic ankle instability: a randomized controlled trial.
Acronym The effects of hip-focused exercise on chronic ankle instability.
Scientific Title The effects of hip-focused exercise intervention in individuals with chronic ankle instability: a randomized controlled trial.
Scientific Title:Acronym The effects of hip-focused exercise on chronic ankle instability.
Region
Japan

Condition
Condition Chronic ankle instability
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of hip-focused exercise on chronic ankle instability.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Validated questionnaires (assessments of perceived ankle instability and ankle function)
Key secondary outcomes Dynamic balance
Static balance
Hip muscles strength
Ankle muscles strength

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Hip muscles strengthening and balance training(4 week, 3 times/week)
Interventions/Control_2 Ankle muscles strengthening and balance training (4 week, 3 times/week)
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
40 years-old >
Gender Male and Female
Key inclusion criteria 1) Having a history of a lateral ankle sprain resulted in at least 1 interrupted day of physical activity.
2) Having a history of two or more lateral ankle sprains and/or episodes of "giving way".
3) Perceived instability will be identified by questionnaires (Cumberland Ankle Instability Tool).
Key exclusion criteria 1) Having a history of fracture or surgery in the lower limb
2) Having a history of acute injuries of other joints of the lower limb within three months.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Mina
Middle name
Last name Samukawa
Organization Hokkaido University
Division name Faculty of Health Sciences
Zip code 060-0812
Address West 5, North 12, Kita-ku, Sapporo, Hokkaido, Japan
TEL 0117063329
Email mina@hs.hokudai.ac.jp

Public contact
Name of contact person
1st name Yuta
Middle name
Last name Koshino
Organization Hokkaido University
Division name Faculty of Health Sciences
Zip code 060-0812
Address West 5, North 12, Kita-ku, Sapporo, Hokkaido, Japan
TEL 0117063329
Homepage URL
Email yutakoshino16@gmail.com

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The ethics committee of Faculty of Health Sciences, Hokkaido University
Address West 5, North 12, Kita-ku, Sapporo, Hokkaido, Japan
Tel 011-706-3316
Email shomu@hs.hokudai.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
2020 Year 04 Month 23 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
2020 Year 04 Month 15 Day
Date of IRB
2020 Year 08 Month 18 Day
Anticipated trial start date
2020 Year 11 Month 02 Day
Last follow-up date
2023 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
2020 Year 04 Month 23 Day
Last modified on
2020 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045892

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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