Protocol summary

Study aim
Study of effect and persistence of six weeks of wobble board training and kinesiotape on joint position sense, lower extremity function and balance in athletes with functional ankle instability
Design
36 female athletes with functional ankle instability divided into two experimental and one control groups. The simple randomization method was used to assign individuals to two groups that in this method, random allocation software was used to create a random sequence.
Settings and conduct
The present study is a quasi-experimental research with a pre-test post-test design and follow up with two experimental group and a one control group. 36 Female Athletes with Functional Ankle Instability randomly divided into two experimental and one control groups. Position sense, lower extremity function and balance are measured before and after and one month after stopping exercises.
Participants/Inclusion and exclusion criteria
Female athletes in the age range of 20 to 30 years old; history of at least one ankle inversion injury in the last two years; ability to bear body weight; normal gait and full range of motion in the ankle joint
Intervention groups
First Intervention Group Includes Female Athletes with Functional Ankle Instability who Receive Wobble Board Training. The Second Intervention Group Includes Female Athletes with Functional Ankle Instability who Receive Kinesiotape. The Control Group Includes Female Athletes with Functional Ankle Instability who did not Receive any Intervention.
Main outcome variables
Position sense; lower extremity function; balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200107046035N6
Registration date: 2021-11-03, 1400/08/12
Registration timing: prospective

Last update: 2021-11-03, 1400/08/12
Update count: 0
Registration date
2021-11-03, 1400/08/12
Registrant information
Name
Hossein Shahrokhi
Name of organization / entity
Hakim Sabzevari University
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 2756
Email address
h.shahrokhi@hsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of effect and persistence of six weeks of wobble board training and kinesiotape on joint position sense, lower extremity function and balance in athletes with functional ankle instability
Public title
Effect of six weeks of wobble board training and kinesiotape on joint position sense, lower extremity function and balance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female athletes in the age range of 20 to 30 years old A history of at least one ankle inversion injury in the last two years Ability to bear body weight Normal gait and full range of motion in the ankle joint
Exclusion criteria:
History of lower extremity injury History of lower extremity surgery Balance disorders Participate in a rehabilitation program for the past six months
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
The simple Randomization Method was used to assign individuals to three groups that in this method, Random Allocation Software was used to create a random sequence. Then, in order not to determine which group the individuals will be assigned to before dividing them into two groups, or in other words, allocation concealment, the central randomization method was used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sport Sciences Research Institute
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2021-07-20, 1400/04/29
Ethics committee reference number
IR.SSRC.REC.1400.073

Health conditions studied

1

Description of health condition studied
Functional Ankle Instability
ICD-10 code
M25.3
ICD-10 code description
Other instability of joint

Primary outcomes

1

Description
Joint Position Sense
Timepoint
At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention and One Month After Stopping Training
Method of measurement
Ankle Proprioception Goniometer

2

Description
Lower Extremity Function
Timepoint
At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention and One Month After Stopping Training
Method of measurement
Foot and Ankle Ability Measure Scale

3

Description
Balance
Timepoint
At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention and One Month After Stopping Training
Method of measurement
Y Balance Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Wobble Board Training for 6 weeks, 3 sessions per week, 2 hour per session
Category
Treatment - Other

2

Description
Intervention group: Kinesiotape for 6 weeks, 3 sessions per week, 2 hour per session
Category
Treatment - Other

3

Description
Control group: Without any training and just doing normal daily activities
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Raja University
Full name of responsible person
Zeynab Aligoli
Street address
Novrizian, Motahhari blvd.
City
Qazvin
Province
Qazvin
Postal code
95834-34148
Phone
+98 28 3367 7101
Email
z.aligoli2019@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Raja university
Full name of responsible person
Hadi Miri
Street address
Novrizian, Motahhari bolv
City
Qazvin
Province
Qazvin
Postal code
95834-34148
Phone
+98 28 3367 7101
Email
hd.miri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Raja university
Proportion provided by this source
5
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercise
Street address
Hakim Sabzevari University - Tohidshahr - Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98514401101
Email
h.shahrokhi@hsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercise
Street address
Hakim Sabzevari University - Tohidshahr - Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98514401101
Email
h.shahrokhi@hsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hakin Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercise
Street address
Hakim sabzevari university - Tohidshahr - Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98514401101
Email
h.shahrokhi@hsu.ac.ai

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
All potential data can be shared after people have not been identified
When the data will become available and for how long
Start the access period one year after printing the results
To whom data/document is available
Data will be available to academic and scientific researchers
Under which criteria data/document could be used
Any kind of functional analysis on the submitted data is allowed
From where data/document is obtainable
by Email: h.shahrokhi@hsu.ac.ir
What processes are involved for a request to access data/document
by Email: h.shahrokhi@hsu.ac.ir and the reason for using the documents
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