UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051006 |
|---|---|
| Receipt number | R000058143 |
| Scientific Title | The effect of 12 weeks of tai chi training on function, balance, and pain in athletes with ankle instability |
| Date of disclosure of the study information | 2023/06/02 |
| Last modified on | 2023/05/08 15:13:28 |
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Basic information
Public title
Effect of tai chi training on ankle instability
Acronym
Effect of tai chi training on ankle instability
Scientific Title
The effect of 12 weeks of tai chi training on function, balance, and pain in athletes with ankle instability
Scientific Title:Acronym
The effect of 12 weeks of tai chi training on function, balance, and pain in athletes with ankle instability
Region
| Asia(except Japan) |
Condition
Condition
Functional ankle instability
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effect of 12 weeks of Tai Chi training on the performance, balance, quality of life, and pain of athletes with ankle instability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Ankle Instability
Key secondary outcomes
Fear of movement
Quality of life
Perceived treatment effect
Ankle function
Balance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The tai chi rehabilitation program in the present study is derived from the traditional Yang style, and the main program will include 9 forms of tai chi. Participants of the tai chi rehabilitation program group will spend 12 weeks of tai chi training three sessions per week for 60 minutes per session. Each training session will consist of 10 minutes of warm-up, 45 minutes of the main part of the training program, and 5 minutes of cooling down. Each training session will be managed and supervised by a professional Tai Chi coach.
Interventions/Control_2
Participants in the control group continued their usual activities.
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
being between 18 and 40 years of age
experienced a significant ankle sprain accompanied by inflammatory symptoms (pain, swelling, etc.)
at least one day of sports time loss occurred in the last year
scored equal and more than 24 in the Cumberland ankle instability tool
Key exclusion criteria
positive ligamentous laxity (anterior drawer and Talar tilt tests)
a history of other injuries in either lower extremity during 3 months prior to study enrollment
a history of fracture or surgery in either lower extremity
any other muscular, joint, or neurological conditions that affect lower limb function
currently enrolled in an ankle rehabilitation program
and visual, vestibular, and cognitive deficits
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Aynollah |
| Middle name | |
| Last name | Naderi |
Organization
Shahrood University of Technology
Division name
Sports science
Zip code
3619995161
Address
Shahrood University of Technology, Shahroud, Semnan Province, Iran
TEL
982332392204
ay.naderi@shahroodut.ac.ir
Public contact
Name of contact person
| 1st name | Seyyed Zahed |
| Middle name | |
| Last name | Ebrahimi |
Organization
The University College of Omran-Tosseeh
Division name
Sports science
Zip code
5615735617
Address
Aref Crossroads, University Square, Hamedan
TEL
988138230410
Homepage URL
zahedebrahimi@gmail.com
Sponsor or person
Institute
The University College of Omran-Tosseeh
Institute
Department
Personal name
Funding Source
Organization
The University College of Omran-Tosseeh
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shahrood University of Technology
Address
Haft Tir Square, Shahrood University of Technology
Tel
98 938 006 4684
ay.naderi@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
| 2023 | Year | 06 | Month | 02 | 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
| 2023 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 08 | Day |
Last modified on
| 2023 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058143
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