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 | 2025/04/27 09:41:18 |
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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
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
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
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
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000045892
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
7
Results
The Cumberland Ankle Instability Tool score for subjective instability was significantly improved only in the hip strength + balance training group between before and after intervention. The total score of the Balance Error Scoring System, a static postural balance index, was improved in the hip strength + balance training group and in the ankle strength + balance training group after the intervention compared to before. However, there were no significant group differences in any of the outcomes.
Results date posted
| 2025 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Seven patients with chronic ankle instability were randomly divided into two groups: a hip muscle strengthening (hip joint abduction, external rotation, and extension muscle strengthening) + balance training group and an ankle joint muscle strengthening (ankle joint plantar flexion, dorsiflexion, external and internal rotation muscle strengthening) + balance training group.
Participant flow
Participants were randomly assigned to one of the groups using the envelope method.
Adverse events
None.
Outcome measures
Foot and Ankle Ability Measure, Cumberland Ankle Instability Tool, Balance Error Scoring System, Y Balance Test, hip abduction and external rotation muscle strength
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2025 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045892
