UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051746 |
|---|---|
| Receipt number | R000059059 |
| Scientific Title | Physical and psychological effects of using water therapy in the rehabilitation of athletes with chronic ankle instability |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2023/07/29 02:05:52 |
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Basic information
Public title
Physical and psychological effects of water therapy in athletes with chronic ankle instability
Acronym
CAI
Scientific Title
Physical and psychological effects of using water therapy in the rehabilitation of athletes with chronic ankle instability
Scientific Title:Acronym
CAI
Region
| Asia(except Japan) |
Condition
Condition
chronic ankle instability
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study intends to compare the effect of 8 weeks of water therapy with dry exercise on the performance, balance, and quality of life of athletes with chronic ankle instability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ankle instability
Postural control
Key secondary outcomes
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
| Other |
Interventions/Control_1
Exercise in water
Interventions/Control_2
Exercise on land
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
| 20 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Recommendations of the International Ankle Consortium
Cumberland Ankle Instability Tool (CAIT) score more than 25
Key exclusion criteria
Positive anterior drawer test and/or talar tilt test
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 | 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
Homepage URL
Ay.naderi@shahroodut.ac.ir
Sponsor or person
Institute
Shahrood University of Technology
Institute
Department
Personal name
Funding Source
Organization
Shahrood University of Technology
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
| 2024 | Year | 02 | Month | 01 | 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
| 2023 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 10 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059059
