Protocol summary

Study aim
The effect of a aquatic exercise course on ankle dorsiflexion range of motion, lower limb motor performance screening, ankle self-report scores, sensorimotor performance elements, functional tests in athletes with chronic ankle instability.
Design
40 male athletes (20 in each group) participated in this study. They were selected purposefully based on the entry and exit criteria and were randomly divided into two groups (control group and experimental group).
Settings and conduct
The experimental group does aquatic exercise for 8 weeks, the place of exercises (protocol) is in the pool They did three sessions a week for (1/5) an hour and a half with specific methods of warming up, the main exercise, the number of sets, rests and the number of movements. The control group did not do any intervention and continued their exercises.
Participants/Inclusion and exclusion criteria
Admission: history of sprained ankles in the last two years, feeling of empty ankles twice in the last six months, obtaining the specified score in all four questionnaires, having the age range (18-30) years, voluntary consent of the subjects to participate in the research. Failure to enter: not having a history of ankle sprains in the last two years, not having the feeling of emptying the ankle twice in the last six months, not obtaining the specified score in all four questionnaires, not having the age range (18-30) years.
Intervention groups
People in two groups (experimental group did daily exercises and a specialized and specified water sports intervention for 8 weeks, which is designed to be effective for athletes with chronic ankle instability), (interventional control group) did not do and followed up their daily exercises) were divided.
Main outcome variables
Functional Movement, Sensorimotor Function

General information

Reason for update
Acronym
AQE-CAI
IRCT registration information
IRCT registration number: IRCT20230709058724N1
Registration date: 2024-06-29, 1403/04/09
Registration timing: retrospective

Last update: 2024-06-29, 1403/04/09
Update count: 0
Registration date
2024-06-29, 1403/04/09
Registrant information
Name
Saeed Zarei
Name of organization / entity
The University of Shahrekord
Country
Iran (Islamic Republic of)
Phone
+98 25 3885 4864
Email address
saeidzareei1999@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-17, 1402/04/26
Expected recruitment end date
2023-07-28, 1402/05/06
Actual recruitment start date
2023-06-27, 1402/04/06
Actual recruitment end date
2023-07-23, 1402/05/01
Trial completion date
2023-10-02, 1402/07/10
Scientific title
The effect of aquatic exercise on Functional Movement Assessments and Elements of Sensorimotor Function in Athletes with Chronic Ankle Instability
Public title
The effect of aquatic exercise on Athletes with Chronic Ankle Instability
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Athletes (basketball, handball, volleyball, futsal) History of ankle sprains in the last two years Twice feeling empty ankles in six months Obtaining the determined score in four questionnaires Male athletes (18-30) with chronic ankle instability Three years of sports experience with three sessions a week No history of spine or lower limb surgery No hearing problems Not having balance problems
Exclusion criteria:
Acute Ankle Sprain (less than 6 weeks old) Severe Lower Limb Injuries like fractures, ligament tears requiring surgery uncontrolled medical conditions like heart disease, high blood pressure, or neurological disorders
Age
From 18 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will randomly assign to either the aquatic exercise group or the control group using a computer-generated random sequence with a 1:1 allocation ratio. This randomization sequence will be generated by an independent statistician not involved in participant recruitment or data collection. Allocation concealment was achieved using sequentially numbered, opaque envelopes. These envelopes contained pre-printed group assignments and were opened only after obtaining informed consent and completing baseline assessments for each participant.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will employ a single-blind randomized controlled trial design. Participants will be aware of their group assignment (aquatic exercise group or control group) throughout the study duration. However, all data collection procedures will be standardized to minimize potential bias from assessors. Data analysts will be blinded to group assignment until after all data collection complete and the primary analyses conduct. A single, un-blinded researcher not involve in data collection or participant interaction will maintain the randomization sequence and ensured proper allocation concealment.
Placebo
Not used
Assignment
Parallel
Other design features
two control and experimental groups. The experimental group performs the water sports protocol along with the sports exercises, and the control group performs their own sports exercises.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University
Street address
Rahbar Boulevard, Shahrekord University
City
Chaharmahal va Bakhtiari
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۸۶۳۴۱۴۱
Approval date
2023-11-11, 1402/08/20
Ethics committee reference number
IR.SKU.REC.1402.036

Health conditions studied

1

Description of health condition studied
Chronic ankle instability
ICD-10 code
M25.37
ICD-10 code description
Other instability, ankle and foot

Primary outcomes

1

Description
Motor performance and sensory-motor performance elements
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
8 specialized tests(1-Knee to wall dorsiflexion ankle test 2-Stroke balance test 3-Y balance test 4-Functional movement screen 5-Side–hop test 6-Figure-of-8-Hop Test 7-Triple hop for distance 8-Assessment of sensory-motor function

Secondary outcomes

1

Description
After the implementation of the water exercise protocol on chronic ankle instability in the study, the secondary outcome variable can be "quality score of ankle questionnaires and self-report" and "lower limb motor performance screening scores" and "static and dynamic balance test and range of motion" ankle dorsiflexion and elements of sensory-motor and functional function.
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
پرسشنامه (1-پرسشنامه بی ثباتی مچ پای کامبرلند 2- پرسشنامه تشخیص بی ثباتی عملکردی مچ پا 3-مقایس سنجش توانایی پا و مچ پا 4- مقیاس سنجش توانایی پا و مچ پل در فعالیت ورزشی) 8 تست تخصصی(1-آزمون رساندن زانو به دیوار 2-آزمون تعادل ایستا لک لک 3-آزمون تعادل پویا 4-آزمون غربالگری حرکات عملکردی 5-آزمون جهش جانبی 6-آزمون جهش هشت لاین 7-آزمون سه لی برای مسافت 8-ارزیابی عملکرد حسی-حرکتی

Intervention groups

1

Description
Intervention Group: Aquatic exercises that focus on the ankle joint start from the first week with the least resistance and gradually intensify until the eighth week and reach the maximum pressure. These exercises include the following: increasing the load (resistance exercises), improving agility and jumping (after reaching the necessary preparation). And tools such as: water noodle, swimming board, rope, ladder have been used.
Category
Rehabilitation

2

Description
Control group:Participants in the control group will continue their daily activities and routine work (team or individual exercises three times a week).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord University
Full name of responsible person
Saeed Zarei
Street address
Leader Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۸۶۳۴۱۴۱
Phone
+98 38 3232 4401
Email
saeidzareei1999@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Department of Sports and Youth
Full name of responsible person
Saeed Zarei
Street address
Imam Hossein Square
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۷۳۴۷۵ – ۸۸۱۶۴
Phone
+98 38 1225 1000
Email
saeidzareei1999@gmail.com
Web page address
https://chb.msy.gov.ir
Grant name
Finance and research plan
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Sports and Youth
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Shahrekord University
Full name of responsible person
saeedzarei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports pathology and corrective movements
Street address
Leader Blvd
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۷۳۴۷۵ – ۸۸۱۶۴
Phone
+98 38 1225 1000
Email
saeidzareei1999@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sharekord University
Full name of responsible person
sajad bagherian dehkordi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports pathology and corrective movements
Street address
Leader Blvd
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۷۳۴۷۵ – ۸۸۱۶۴
Phone
+98 38 1220 1000
Email
sajjadbagherian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
ShahreKord University
Full name of responsible person
Saeed Zarei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports pathology and corrective movements
Street address
Leader Blvd
City
ShahreKord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۷۳۴۷۵ – ۸۸۱۶۴
Phone
+98 38 1220 1000
Email
saeidzareei1999@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data can be shared.6
When the data will become available and for how long
The access period starts one year after the results are published
To whom data/document is available
Academic and scientific researchers
Under which criteria data/document could be used
For use in future research
From where data/document is obtainable
saeidzareei1999@gmail.com
What processes are involved for a request to access data/document
One year after the statistical analysis and summarization of all the results and all the mentioned documents will be provided to you.
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