UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040229
Receipt number 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 2023/04/26 09:20:51

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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 or person

Institute

Hokkaido University

Institute

Department

Personal name



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

Enrolling by invitation

Date of protocol fixation

2020 Year 04 Month 15 Day

Date of IRB

2020 Year 08 Month 18 Day

Anticipated trial start date

2021 Year 05 Month 10 Day

Last follow-up date

2024 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

2023 Year 04 Month 26 Day



Link to view the page

Value
https://center6.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