UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056615 |
|---|---|
| Receipt number | R000064705 |
| Scientific Title | Optimizing strategies for the prevention of chronic ankle sprains: |
| Date of disclosure of the study information | 2025/01/30 |
| Last modified on | 2025/01/02 15:42:08 |
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Basic information
Public title
Optimizing strategies for the prevention of chronic ankle sprains:
Effectiveness of Balance-Strengthening and Hopping Exercises in Reducing Lower Extremity Kinetic Risk Factors for Chronic Ankle Sprain Among Elite Female In-Line Speed Skaters: A Multi-Arm Parallel-Group Randomized Trial
Acronym
Optimizing strategies for the prevention of chronic ankle sprains:
Scientific Title
Optimizing strategies for the prevention of chronic ankle sprains:
Scientific Title:Acronym
Acronym
Region
| Asia(except Japan) |
Condition
Condition
Multi-Arm Parallel-Group Randomized Trial
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to address the significant gap in the literature regarding the most effective exercise interventions for preventing Chronic ankle instability (CAI)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Lower Extremity Kinetic Risk Factors for Chronic Ankle Sprain
Key secondary outcomes
Joint Repositioning Error
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The hopping exercise protocol
Interventions/Control_2
balance-strengthening protocol
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
| 15 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
The inclusion criteria required participants were age ranged from 15 to 25 years old and they had all experienced at least 4 years of professional ISS regular exercises, to have a history of at least one inversion ankle sprain that necessitated protected weight bearing, immobilization, and restricted activity for a minimum of 24 hours[25]. The initial sprain must have taken place more than one year before the participant enrolled in the study[26]. Achieving a Cumberland Ankle Instability Tool (CAIT) score of 25 or lower on the affected side[27].
Key exclusion criteria
Participants were excluded: The recurrence of ankle sprain injury during the study period, if they had a history of participants were excluded if they had a history of lower extremity injuries that restricted movement [28, 29], any noticeable musculoskeletal deformities in the lower extremities or upper body while in a normal standing posture [30, 31], or if they missed more than three sessions or two consecutive sessions of the intervention program
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | Esmaeil |
| Middle name | |
| Last name | Mozafaripour |
Organization
Guilan University
Division name
Faculty of sport science
Zip code
1445955985
Address
5th Kilometer of Persian Gulf Highway, Rasht, Guilan Province, Iran
TEL
+989192787818
e.mozafaripour@yahoo.com
Public contact
Name of contact person
| 1st name | Esmaeil |
| Middle name | |
| Last name | Mozafaripour |
Organization
guilan university
Division name
Faculty of sport science
Zip code
1445955985
Address
5th Kilometer of Persian Gulf Highway, Rasht, Guilan Province, Iran
TEL
+989192787818
Homepage URL
e.mozafaripour@yahoo.com
Sponsor or person
Institute
Azad university
Institute
Department
Personal name
Funding Source
Organization
no funding
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
Guilan university
Address
5th Kilometer of Persian Gulf Highway, Rasht, Guilan Province, Iran
Tel
+989192787818
e.mozafaripour@yahoo.com
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
| 2025 | Year | 01 | Month | 30 | 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
39
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
Terminated
Date of protocol fixation
| 2024 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 02 | Day |
Last modified on
| 2025 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064705
